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  • Internal

    £22,000
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    We are hiring for spots in April and across our Summer intake this year. We have come into 2021 in a very strong position and are excited to bring the next group of graduates through our training programme to start an exciting career within recruitment!

    About Skills Alliance

    Skills Alliance Group is a Global Life Science, Medical Device & Technology, and Animal Health recruitment company encompassing three business units: SA Executive, SA Staffing & SA Consulting.

    For the past 15 years, we have been providing innovative and bespoke recruitment solutions that facilitate our clients need to hire exceptional talent quickly. To date we count many of the leading pharmaceutical, biotechnology, biopharma and CROs as our partners, and we are proud to be contributing to the discovery, development and distribution of safe and effective therapeutics across the globe.

    If you are a graduate and unsure on what recruitment company or sector to join pharma is one of, if not the top and most stable sector to be working in right now. 2020 was a record year for us in regards to promotions and personal billing achievements, we made zero redundancies with the virus and actually grew our global headcount by 20%.

    The core values of our business dictate and shape every decision we make. We therefore behave with agility, continuously improve and are always proactive in every action we take. We also like to have a lot of fun on the way.

    Why Skills Alliance?

    We have a vibrant office based in the City of London that is growing rapidly and have continued to grow through COVID. We come to work every day to do something we love and are genuinely passionate about the industry that we work in. We always conduct employee engagement surveys and the one thing that all of our staff say they love the most about us is the people and culture. We have an amazing culture that we have worked hard on creating. We also work only mid to senior level appointments as well as retained searches which means higher fees and in return the opportunity to earn much more commission.

    What we offer:

    • Competitive basic salary and potential to earn some serious cash: we offer £22,000 on start increasing to £25,000 at 6 months. You can earn up to £60,000 in your first year and over £100,000 in your second year
    • The perks: A fun and extremely buzzy office with perks such as dress down Fridays, beers in the office on Fridays with an early finish, a summer party, huge Christmas party, loads of social events and monthly Director drinks.
    • Benefits: such as flexi time, working from home, private health insurance, corporate gym membership, office meditation sessions, health & wellness programme, duvet days, birthdays off and a generous vacation allowance.
    • Incentives: such as lunch clubs, 2x yearly holiday incentives (previous destinations include Croatia, Ibiza, South of France & Budapest, fantasy recruitment league, the £100K club and quarterly team incentives.
    • 5* Dining: We love a lunch club and the opportunity to have a ½ day at work followed by an all-expenses paid lunch at some of the top restaurants in London
    • Career progression: based on meritocracy. We believe in promoting on merit and not tenure. Promotion to consultant within 6 months and senior consultant 12 months
    • Uncapped commission: structure up to 30% and no cap at all on how much you actually make. you also earn commission from day one.
    • Learning and Development: a supportive and structured environment which includes weekly training delivered by our Global Learning Development Manager and Senior Management Team as well as retainer training directly from our CEO
    • International office relocation: for people who want to work in our other offices (New York, Seattle, Newport Beach and Zurich)

     

    The Trainee Training Academy

    We have a strong track record in training and developing our staff to the highest level and our learning and development function is headed up by somebody who has over the years produced many top billers. As a new employee you will go through an initial 4-week intensive programme learning about the recruitment sector and your market. Every employee will have training throughout their career to ensure that you will always have access to the best support and development.

    The Trainee Academy is where the basics of Recruitment are covered and the participants can learn and practice in a safe environment before being exposed to candidates and clients, peer to peer mentoring, call coaching and modelling success on the companies’ high performers. There then follows psychometric self-development assessment and continual one to one mentoring

    Duties of a Graduate Recruitment Consultant:

    • Business Development and building business relationships as well as cold calling
    • Headhunting and identifying suitable candidates
    • Negotiating and objection handling
    • Qualifying candidates and building candidate networks
    • Arranging and preparing candidates for interviews
    • Lead & referral generating
    • Learning to become an expect in your market

    What skills do you need?

    • A minimum of a bachelor’s degree – Graduating in 2020 or 2021
    • Strong communication skills and the ability to develop new business relationships
    • Ability to listen, learn and apply new ideas quickly
    • A confident personality and will not be afraid to get on the phones
    • Previous sales experience would be highly advantageous
    • Ability to achieve set targets and working to deadlines.
    • Entrepreneurial, ambitious and enjoy a fast paced, but challenging atmosphere.
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    Skills Alliance is a fast growing, specialist life science recruitment firm with offices in London, New York, Seattle, Newport Beach and Zurich. Due to client demand and subsequent business growth, we are looking to hire ambitious, driven and self-motivated Principal Consultants to build on our current success and become future business leaders.

    We are open to consultants from any specialist sector, for example energy or finance who are now looking for a change in market and the opportunity to develop with a fast growing International business.

    We offer uncapped commission, good basic salaries, career development based on ability rather than tenure, individual and team incentives and a very entrepreneurial work atmosphere. The business offers a specialist, boutique feel but with the opportunity to develop your career quickly by working with a highly experienced and internationally recognised senior management team.

    As a new employee you will benefit from the following:

    • The ability to work with market leading consultants and work on and influence top tier executive search work
    • Travel across Europe and Internationally
    • Monthly, quarterly and bi-yearly incentives and holidays
    • Freedom to share and implement your own ideas

    Your primary duties will be focused on building up your specialist vertical market, becoming a subject matter expert and developing your brand and identity within Skills Alliance and the industry. On a day to day basis the core duties for this position will involve:

    • To drive growth and develop the specified vertical market for Skills Alliance on a Pan European basis.
    • You will act as a 360 consultant and as such will be responsible for both client and candidate development.
    • To achieve consistent and rising revenue generation within the specified vertical of the Life Sciences / Pharmaceutical sector.
    • The successful candidate will be expected to offer constructive, entrepreneurial and forward thinking ideas and concepts to assist in the development and growth of Skills Alliance as a leading Global Pharmaceutical Recruitment business.
    • To attend Industry specific conferences and symposia on behalf of Skills Alliance and represent the brand and organization. Build talent-pools of candidate resumes and establish yourself within a vertical market.
    • Screen resumes and qualify potential candidates about suitable job vacancies.
    • Develop leads for new business and conduct business development with new clients within the target vertical by agreeing working agreements and establishing terms of business with Life Sciences / Pharmaceutical companies.

    Additional requirements

    • Ideally you will have a minimum of a University degree
    • Strong communication skills and the ability to build relationships with a variety of customers.
    • At senior level, we would be looking at full 360 recruitment experience with an ability to demonstrate client and candidate acquisition.
    • An ability to listen, learn and apply new ideas quickly
    • Most importantly, we want to hear from people who always strive to be the best at anything they apply themselves to do.

     

    If you are interested in a confidential discussion, please do apply to this job advert with a CV and cover letter explaining the reasons for your interest in the position.

  • Market Access

    Highly competitive salary and benefits
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    Skills Alliance has partnered exclusively with a leading Diabetes company to hire a Head of Market Access DACH. The organisation is dedicated to developing technology that improves the lives of patients with diabetes.

    The Head of Market Access DACH is responsible for the design and delivery of the Market Access strategy to maximise access to their products in the region and prepare for a series of new launches. This will include building strong value dossiers, an optimised pricing strategy, educating key stakeholders, and influencing medical policy decisions.

    The location of the position is flexible within Germany.

    Requirements:

    • Degree in Health Economics, Medicine or another subject relating to Market Access
    • Experience in the Life Sciences industry (previous diabetes experience is an advantage but not essential)
    • Expert knowledge of the German reimbursement system, including government legislation, regulatory system and insurance system
    • Experience creating value dossiers and completing HTA submissions, leading or contributing to price negotiations, and working with Health Economists to produce cost-effectiveness and budget impact models
    • Knowledge of the Swiss and Austrian reimbursement system is an advantage but not essential
    • Ambitious and driven individual with excellent communication skills and a desire to work collaboratively with cross-functional colleagues
    • Fluent in German and English

    The salary and benefits are highly competitive and dependent on the level and quality of previous experience.

    For a full job description and client briefing, please call Oliver Drew on +44 (0) 203 862 9603 or email him to arrange a confidential discussion.

  • Regulatory

    £60 - £63 per hour
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    Skills Alliance are partnering with a very exciting Global Biopharmaceutical Company who are focusing on bringing a new drug through from the clinical trial to commercialisation across Europe.

    They need a strong Regulatory Affairs Manager who is able to support to the Intercontinental & Global Patient Solutions team with initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals.

    This will be a 5 day a week freelance position for 12 months initially to be based in London and an excellent rate on offer.

    Please attach your CV to your application to ease the process.

    Email: shakir.hossain (at) skillsalliance.com

  • Clinical Operations

    Excellent Salary and Package
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    An innovative, Swedish Biotechnology company in Southern Sweden, are now looking to grow their clinical team after starting their treatment on for immuno-oncology. This role opening is very time urgent so do not hesitate to apply.

    They specialise in early phase research they are currently amid revolutionary treatment of haematology and solid tumours. Because of this they require strong trial management experience within Oncology, ideally early phase experience (I and II). They would prefer experienced candidates in Pharma/Biotech but will consider CRO candidates too.

    They are looking for: (Senior) Clinical Project Manager

    (Senior) Clinical Project Manager – with at home flexibility, minimal travel.
    – Need to be open to being in the office 2-3 days a week, you will have the flexibility to work from home.
    – Project, study, or trial management experience.
    – Experience in Oncology, as well as managing Oncology based studies.
    – Oncology experience is essential.

    – Proficient in written and spoken English.

    This is a full time and permanent position.
    It is office based in Southern Sweden, with flexibility.

    They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Brie Welch for more details on +44 (0)204 513 0648 or click APPLY NOW.

  • Clinical Development

    £50000 - £70000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (Euston). They will offer a very competitive salary – circa £60-70K depending on experience + full benefits package.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

  • Clinical Development

    £60000 - £80000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £50000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team and will consider CRO or Pharma experience, this would be working on studies at the cutting edge of science. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    Excellent Salary and Package
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    An upcoming German owned Biotech company is now looking to grow their clinical team after starting new developments in Oncology treatment. This role opening is time urgent so do not hesitate to apply.

    They are a small biotech within Munich and are currently and are looking for an experienced Clinical Trial Associate to join the team and make a difference through their organised nature and their strong administrative ability. This is an opportunity to be a part of the process from the very beginning, a hands on role with a small and welcoming team.

    This is a permanent, full time role, so this means there may be a scope for progression within the firm. They are going through major development regarding bringing on a new electronic TMF system. Which is why they need an experienced clinical trial associate with a strong clinical background.

    Clinical Trial Associate/Assistant – office based

    – Must be willing to commit to into the office 5 days a week.

    – Have experience in eTMF management.

    – Experience in TMF.

    – Proficient in written and spoken English.

    This is a full time and permanent position.

    They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Brie Welch for more details on +44 (0)204 513 0648 or click APPLY NOW.

  • Medical affairs

    £65000 - £75000 per annum, car allowance + bonus
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    Senior Compliance Officer – Brand new role, brand new team

    I am currently working with a client of mine who are looking for an addition to their small compliance team. This is a brand-new team, and so you will be joining as part of a new role within the team and will play a pivotal role in championing compliance across the business.

    My client are specialists across various therapeutic areas and are building a compliance team that can promote the vision of compliance across the company.

    For this position, my client is looking for someone who has experience in a healthcare compliance role. You must have an excellent understanding of the ABPI and IPHA codes of practice. You will be working as part of the compliance team to ensure that these codes of practice are adhered to and you will be the point of contact for compliance in the company.

    Although this is a UK and Ireland role, this position will give you the opportunity to work closely with the EU affiliates as well as working closely with other functions within the company such as sales and marketing and regulatory affairs, as well as medical affairs.

    This is a great opportunity for anyone looking to take the next step in their career and is perhaps looking for a position in which they can take on a wealth of experience and be part of a growing team, with opportunities for growth in the future.

    For more information, please contact Chanel Hicken on 0207 220 6206 for a confidential discussion.

  • Quality

    Competitive + Benefits
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    An expanding Sterile manufacturing company are currently looking to appoint a Quality Director. Already possessing an impressive portfolio they intend to develop this further with their current pipeline making this position pivotal in being able to fulfil this strategy.

    You will be working alongside the Managing Director and be responsible for directing and implementing strategies across the business. You will also be responsible for ensuring compliance with regulatory requirements and managing the internal compliance programs associated with the entire product lifecycle. Experience with QMS management, internal and external audits including site inspection readiness by the FDA & MHRA are essential.

    The main responsibilities of this position will be:

    • Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary other Senior Executives and Non-Executives.

    • Oversee the internal GMP and quality system audit program for all products.

    • Design, implement, and administer a management escalation process to ensure appropriate issues are elevated for management awareness and intervention.

    • Facilitate the management review process with executive management.

    • Ensure the quality and compliance of all required regulatory notifications.

    • Communicate with regulatory bodies as necessary and host regulatory inspections, as necessary.

    • Monitor the external FDA & MHRA regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance.

    • Develop and sustain a high performing team of direct reports, with attention to development and succession planning.

    • As a member of the Executive Team, contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing Development analysis and guidance on all activities, plans, targets and business drivers.

    • To grow and develop the business through the identification and progression of opportunities and by establishing strategic collaborations and interactions with third parties including public and private sector bodies.

    • To lead and manage the business, via a management team, to secure the delivery of high-quality products/services in an effective and timely fashion.

    • To deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness.

    • To report on the business and performance of Quality as required to the Board and others.

    • To take responsibility for all HR issues within the division.

    • To actively contribute to the development and achievement of translational and other programmes.

    • To take Executive responsibility for Health and Safety across the company.

    • To contribute to publications in national and international journals as appropriate.

    If this position looks to be well aligned to your skill set, apply now in order to discuss the opportunity further.

  • Quality

    £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a Microbiologist position.

    You would be part of a well-established and well-known Pharma organisation and as the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Supervise the Microbiology Team and be responsible for all microbiological testing
    • Report results to the QA team
    • Manage the Environmental Monitoring program on site
    • Perform sampling and testing of water on site

    Requirements:

    • 3+ years of experience in a similar position
    • GMP, GLP knowledge/ understanding of Data Integrity
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Microbiologist position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Lavina Rose for more details on 02072206218.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Data Management

    £250 - £300 per day
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    Skills Alliance are recruiting on behalf of a global top-20 Medical Device manufacturer, who are seeking an experienced Data Analyst professionals, with a strong, proven track record in process improvement projects across a global environment. You will be working with teams located in South East Asia & Central America, so demonstrable experience working with integrated teams in these locations would be highly beneficial. This will be a 100% remote based role, however you will be required to hold a right to work in the UK.

    Job Purpose:

    • With the introduction and release of a client single product hierarchy, there is a requirement to hire a product support analysis to aid with the development and implementation of new process.
    • Working closely with the stakeholders, the project team and various global and local Subject Matter Experts to define requirements, support process enablement and produce/update documentation to the highest quality and standards. Collect and analysis of data to providing recommendations to the project team and the maintenance of change plans.

    Key Responsibilities:

    • Responsible for the maintenance of the Product Hierarchy source system.
    • Liaise with global Client markets on both strategic and non-strategic EPRs and support the introduction and embedment of new processes.
    • To ensure local NPI process are aligned with the SPH and that proactive steps are taken to continuously maintain and update the source system.
    • Assist with the refinement and deployment of new processes in order to ensure smooth transition.
    • Work with the project team to analyse reports and take steps to educate and develop process capability.
    • Liaise with key stokeholds and provide guidance on required changes.
    • Provide the core project team with weekly progress updates.
    • Ensure source system data is of high integrity.
    • Further development and improvement of associated policy and processes.
    • Develop and maintain training material.
    • Deliver training to global and local teams.

    Required Experience:

    • Minimum of 2 years experience with Process improvements within a large organisation.
    • Minimum of 2 years experiencing collating and interpreting data, and providing meaningful analysis.
    • Some experience of working with a high level of engagements within a global intergrated teams. Will be working with teams based in South East Asia & Central America.
    • Flexible working hours will be critical for this position.

    Desirable Experience:

    • P360 expericence
    • Some knowledge of Master Data desirable.
    • Some exposure to Lean Six Sigma.
    • Experience using Informatica desirable.
    • Certification as a BA and/or BI.
    • Exposure to Change Management techniques
  • Pre-Clinical

    £90000 - £110000 per annum, Bonus + shares
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    Director of pre-clinical role with cutting edge UK based Biotech, who are growing at present. Based in the South East of the UK.

    Evox are a relatively new exosome therapy focussed Biotech. They have unique technology to engineer and use exosomes for drug delivery – a very exciting and new area within advanced therapies so working at the cutting edge of science.

    They are recruiting for multiple Director roles in their pre-clinical team. They would be overseeing a group (around 7 initially, growing to 12, comprising of group leaders and scientists). They are looking for someone who has advanced therapies experience and someone PhD qualified, they also need candidates with strong leadership and line management experience.

    This is a permanent and full-time position. They are based in the South East and it would be an office-based role with flexibility. The salary would be able to offer is around £90-110K for Director + bonus + benefits. Shares/options would also be part of the package.

    This is a full-time and permanent position. It is office-based in the South East with flexibility. They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details on +44 207 220 6209 or click APPLY NOW.

  • Procurement

    €90000 - €120000 per annum
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    Share

    Skills Alliance are working with a global, reputable pharmaceutical organisation who are seeking an experienced R&D Procurement Category Lead with a strong track record in medical affairs. Based in Berlin, this will be an excellent opportunity for someone to grow within a highly-ambitious, strategic procurement function.

    Purpose & Responsibilities:

    • Work within the R&D Procurement team to lead the creation and ensure the implementation of procurement category strategies for key global Medical Affairs categories including late phase clinical studies, real world data, and pharmacovigilance that add significant value for the business (e.g. external innovations, savings, payment terms, increased compliance/sustainability and reduced risk)
    • Keep up to date on category market intelligence and supply market trends to gain competitive market advantage and to make better business decisions (e.g. new potential suppliers), to understand how the innovation potential can be leveraged successfully within (sub-)category
    • Translate results of category strategies, initiatives and projects into sourcing approaches and operational instructions and jointly agree them with external partners
    • Ensure and be accountable that processes and system content reflect category strategy
    • Establish effective, trustful and personal relationships with key business stakeholders to understand business requirements, set joint targets and be the contact point for all procurement related topics for the business stakeholder community
    • Define what value procurement can add for the business stakeholder community and propose strategic initiatives that deliver against the defined value


    Key Requirements:

    • Long-term professional procurement experience
    • Solid category expertise/understanding of R&D/Medical Affairs area
    • Strong stakeholder engagement skills combined with strong influencing skills
    • Ability to work in a global and virtual working environment and to lead virtual teams
    • Good knowledge and expertise in procurement and procurement processes and methodologies
    • Ability to articulate credible pictures and visions of possibilities that will create sustainable value
    • High proficiency level in English, both written and spoken


    Required Education:

    • Master or equivalent degree in science or business management (PhD preferred)
  • Quality

    £35000 - £45000 per annum
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    Share

    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    Share

    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Regulatory

    Competitive
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    Skills Alliance is currently partnered with the leading global pharmaceutical company based in the northern part of Switzerland. For this purpose, our client is looking for a Sr. Regulatory Manager Vaccines Europeto join their team on a 12 month long term Contract with a possibility of further extension.

    OBJECTIVES:
    • Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.
    • Manages assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region
    • Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
    • Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
    • Responsible for regulatory oversight of assigned clinical trials conducted in the region.
    • Collaborates with all regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.
    • Passion for quality in all areas of responsibility
    • Leads and directs the work of others as part of a matrixed organization.

    ACCOUNTABILITIES:
    • Close collaboration with the RAV Europe Region Head (and Local Operating Company (LOCs) RA as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
    • In cooperation with key stakeholders and RAV Europe Region Head (and LOC RA as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right-first-time.
    • Supports overall content and management of local/regional regulatory components and filings e.g. MAA, MA variations. Contributes to local/regional label development and submission.
    • Ensures compliance with both internal process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
    • Supports RAV Europe Region Head in the preparation of health authority interactions/meetings in the region as applicable for specified projects
    • Actively participate as member of teams within RAV supporting activities as assigned.
    • Manages specific projects as assigned.
    • Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.

    EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    • BS, advanced scientific degree preferred.
    • A minimum of 6 years of pharmaceutical industry experience, with a minimum of 4 years of regulatory experience.
    • European regulatory experience is essential. Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval.
    • Vaccines and/or biologics experience is preferred.
    • Participation in Global regulatory filing is a plus.
    • Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
    • Pays strong attention to quality, and is working reliably and thoroughly.
    • Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.
    • Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
    • Team player

    LICENSES/CERTIFICATIONS:
    • None

    PHYSICAL DEMANDS:
    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
    • Carrying, handling and reaching for objects.
    • Ability to sit or stand for long periods of time while traveling.

    TRAVEL REQUIREMENTS:
    • General willingness to travel to meetings, including overnight trips.
    • Requires 10% travel.

    If you are interested or you know someone who would be interested please apply directly here or feel free to contact Heena Verma via phone @ +41 44 798 2410.

    Thanks!

  • Quality

    £50000 - £65000 per annum
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    Share

    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £90000 - £100000 per annum
    Apply

    Job
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £25000 - £35000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Microbiologist

    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a Microbiologist position.

    You would be part of a well-established and well-known Pharma organisation and as the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Supervise the Microbiology Team and be responsible for all microbiological testing
    • Report results to the QA team
    • Manage the Environmental Monitoring program on site
    • Perform sampling and testing of water on site

    Requirements:

    • 3+ years of experience in a similar position
    • GMP, GLP knowledge/ understanding of Data Integrity
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Microbiologist position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Lavina Rose for more details on 02072206218.

  • Quality

    £25000 - £30000 per annum
    Apply

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    Share

    Senior QA Officer

    I am currently exclusively partnering with a very exciting pharmaceutical company who are currently looking for a Senior QA Officer to join their growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in developing and managing quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, offering excellent long-term prospects.

    Responsibilities:

    • To prepare and update SOPs
    • To make sure relevant personnel is trained on new SOPs
    • To prepare and review product quality reviews
    • To prepare monthly summary

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    €90000 - €120000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are working with a global, reputable pharmaceutical organisation who are seeking an experienced R&D Procurement Category Lead with a strong track record in medical affairs. Based in Berlin, this will be an excellent opportunity for someone to grow within a highly-ambitious, strategic procurement function.

    Purpose & Responsibilities:

    • Work within the R&D Procurement team to lead the creation and ensure the implementation of procurement category strategies for key global Medical Affairs categories including late phase clinical studies, real world data, and pharmacovigilance that add significant value for the business (e.g. external innovations, savings, payment terms, increased compliance/sustainability and reduced risk)
    • Keep up to date on category market intelligence and supply market trends to gain competitive market advantage and to make better business decisions (e.g. new potential suppliers), to understand how the innovation potential can be leveraged successfully within (sub-)category
    • Translate results of category strategies, initiatives and projects into sourcing approaches and operational instructions and jointly agree them with external partners
    • Ensure and be accountable that processes and system content reflect category strategy
    • Establish effective, trustful and personal relationships with key business stakeholders to understand business requirements, set joint targets and be the contact point for all procurement related topics for the business stakeholder community
    • Define what value procurement can add for the business stakeholder community and propose strategic initiatives that deliver against the defined value


    Key Requirements:

    • Long-term professional procurement experience
    • Solid category expertise/understanding of R&D/Medical Affairs area
    • Strong stakeholder engagement skills combined with strong influencing skills
    • Ability to work in a global and virtual working environment and to lead virtual teams
    • Good knowledge and expertise in procurement and procurement processes and methodologies
    • Ability to articulate credible pictures and visions of possibilities that will create sustainable value
    • High proficiency level in English, both written and spoken


    Required Education:

    • Master or equivalent degree in science or business management (PhD preferred)
  • Quality

    £30000 - £40000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Senior Quality Associate

    Currently partnering with a leading global contract service company who are currently looking for a Senior Quality Associate to join their rapidly growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in Good Manufacturing Practice to develop and manage quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To liaise with project teams as a key quality contact
    • To provide advice to cross-functional teams
    • To ensure SOPs are up to date
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To perform risk assessments

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
    Apply

    Job
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    Share

    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    €90000 - €120000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are working with a global, reputable pharmaceutical organisation who are seeking an experienced R&D Procurement Category Lead with a strong track record in medical affairs. Based in Berlin, this will be an excellent opportunity for someone to grow within a highly-ambitious, strategic procurement function.

    Purpose & Responsibilities:

    • Work within the R&D Procurement team to lead the creation and ensure the implementation of procurement category strategies for key global Medical Affairs categories including late phase clinical studies, real world data, and pharmacovigilance that add significant value for the business (e.g. external innovations, savings, payment terms, increased compliance/sustainability and reduced risk)
    • Keep up to date on category market intelligence and supply market trends to gain competitive market advantage and to make better business decisions (e.g. new potential suppliers), to understand how the innovation potential can be leveraged successfully within (sub-)category
    • Translate results of category strategies, initiatives and projects into sourcing approaches and operational instructions and jointly agree them with external partners
    • Ensure and be accountable that processes and system content reflect category strategy
    • Establish effective, trustful and personal relationships with key business stakeholders to understand business requirements, set joint targets and be the contact point for all procurement related topics for the business stakeholder community
    • Define what value procurement can add for the business stakeholder community and propose strategic initiatives that deliver against the defined value


    Key Requirements:

    • Long-term professional procurement experience
    • Solid category expertise/understanding of R&D/Medical Affairs area
    • Strong stakeholder engagement skills combined with strong influencing skills
    • Ability to work in a global and virtual working environment and to lead virtual teams
    • Good knowledge and expertise in procurement and procurement processes and methodologies
    • Ability to articulate credible pictures and visions of possibilities that will create sustainable value
    • High proficiency level in English, both written and spoken


    Required Education:

    • Master or equivalent degree in science or business management (PhD preferred)
  • Clinical Operations

    Excellent Salary and Package
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    Share

    I have partnered with an upcoming, Swedish Biopharmaceutical company located in Stockholm. This is a great opportunity to join quite a niche Biopharma from the very beginning.

    They are now looking to grow their clinical team after successfully completing their early phase studies where they have had extremely positive results. This means they will need a Senior Project Manager / Project Lead / Director of Clin Ops that can lead their team on a global scale for their Phase II trials which may be outsourced to CRO’s.


    They are looking for: Senior Clinical Project Manager / Project Lead / Clin Ops Director – with remote working, minimal travel.

    Key Requirements:

    – Proficient in written and spoken English.

    – Ability to work independently, but also lead a global and regional team for clinical trials.

    – They need someone based in Stockholm or able to work remotely and go the office every few weeks.

    – Strong clinical trial/project management experience.

    Preferred:

    – Experience of overseeing and managing outsourced studies in Pharma/Biotech.

    – Happy to do hands on trial management.

    – Experience across phases I, II and III.

    This is a full time and permanent position.
    It is a remote working role, with occasional travel to their Stockholm office.

    They will offer an excellent salary and package, which can be discussed and negotiated if you meet their requirements.

    Skills Alliance are the preferred supplier for this role. Please contact Brie Welch for more details on +44 (0)204 513 0648 or click APPLY NOW.

  • Quality

    £50000 - £65000 per annum
    Apply

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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • HR and talent acquisition

    Rate on application
    Apply

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    Share

    A global biopharmaceutical company are recruiting for a HR Shared Services Advisor based in Uxbridge. This position will be responsible for providing HR support across the European region. They are looking for a contractor who will support and serve as a first point of contact for employees, managers and HR Business Partners, providing high quality HR advice and guidance with a focus on excellent customer service on a wide range of HR activities and processes.

    Key objectives

    • Utilise HRSM technology to triage, track and manage incoming enquiries and cases
    • Perform data entry across a range of HR systems
    • Create and maintain SOPs
    • Contribute to the ongoing development of the HR Shared Services FAQ library
    • Responsible for creating new starter offer documentation and all HR associated onboarding activities
    • Manage the administration of employee recognition programmes
    • Responsible for responding to external HR queries including reference requests
    • Support the preparation of monthly payroll and follow up on payroll queries
    • Manage core HR processes including on-boarding, off-boarding, absence management, benefits administration, and employee transfers
    • Manage employee files and related documentation in HR system
    • Always ensure compliance with appropriate data protection legislation


    Essential skills and experience

    • Must have experience working within an HR Shared Services environment
    • Must have an interest and understanding of general HR policies and procedures
    • Will have a strong customer service orientation while maintaining a high level of integrity and confidentiality
    • Must possess solid verbal, written, interpersonal and telephone communication skills
    • Must be able to identify critical situations and take action to escalate where necessary
    • Must demonstrate the ability to work in a team
    • Must be able to multitask yet remain detailed-oriented with sound time management skills
    • Must possess strong Microsoft PowerPoint, Excel, Word, and Outlook skills
    • Must be able to perform role under minimal supervision
    • Experience with Workday, Service Now or similar HR systems is desirable

    This role is a 6-month contract role on an hourly rate of £16 p/hr.

    Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

  • HR and talent acquisition

    Rate on application
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    A global pharmaceutical company are recruiting for a Project Assistant based in South East England, Surrey. This is an opportunity to join a reputable pharmaceutical company that are undergoing significant changes with a large underdoing Global Transformation programme.

    Objectives: Support the Coordinator in the Team Management activities of the ATL Team and act as the shadow ATL (Back Up) for one of the ATLs who has been assigned the Menassa, Israeli, Dutch, Swiss and Austrian affiliates.

    Deliverables:
    • Coordinate, Update and Monitor Activity Tracker
    • Coordinate/Publish Monthly ATL/FD Reporting and Monitoring List
    • Coordinate Weekly ATL call and daily ATL PMO call

    Experience:
    • Experienced in working across PMO support projects
    • Willing to take initiative and are confident in their abilities
    • Strong attitude to work
    • Strong use of Microsoft Office Excel

    This is a 12 month contract offering a daily rate of £194 a day.

    Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

  • Pre-Clinical

    £90000 - £110000 per annum, Bonus + shares
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    Director of pre-clinical role with cutting edge UK based Biotech, who are growing at present. Based in the South East of the UK.

    Evox are a relatively new exosome therapy focussed Biotech. They have unique technology to engineer and use exosomes for drug delivery – a very exciting and new area within advanced therapies so working at the cutting edge of science.

    They are recruiting for multiple Director roles in their pre-clinical team. They would be overseeing a group (around 7 initially, growing to 12, comprising of group leaders and scientists). They are looking for someone who has advanced therapies experience and someone PhD qualified, they also need candidates with strong leadership and line management experience.

    This is a permanent and full-time position. They are based in the South East and it would be an office-based role with flexibility. The salary would be able to offer is around £90-110K for Director + bonus + benefits. Shares/options would also be part of the package.

    This is a full-time and permanent position. It is office-based in the South East with flexibility. They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details on +44 207 220 6209 or click APPLY NOW.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Manufacturing

    Competitive
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    Skills Alliance is currently partnered with a multinational biotechnology company, leader in the fields of immunology and hematology. On behalf of our client, we’re currently recruiting for a Continuous Improvement Engineer to join our client’s manufacturing site on a permanent basis.

    Purpose
    • Lead or facilitate the resolution of critical issues (Problem Solvings)
    • Lead and support cross-departmental project teams to implement strategic OE projects, producing significant and measurable improvements and tangible financial results for the business.
    • Build Continuous Improvement (CI) capabilities within the organization training and coaching of Blue Belts, Green belts, and Black Belts.
    • Deliver Operational Excellence (OE) related training programs (5S, Blue Belt, or Green Belt trainings).
    • Continue to develop your OE Skills beyond your Black Belt competencies.
    • Deploy the CI Masterplan (Tiered accountability, 5S, Standard work, Visual Management, VSM, Training) • Continuously look for opportunities of improvement that will make the difference.
    • Continuously increase and diversify your OE, process, and business knowledge and understanding.

    Profile:
    • Education: Master degree in Engineering or in Science.
    • Lean and/or 6 Sigma certification is an asset.
    • Eager to develop his/her OE skills
    • Experienced in the biotechnology / pharmaceutical industry is required
    • Superior interpersonal and coaching skills.
    • Demonstrated ability to lead and motivate teams to achieve business goals.
    • Strong negotiation and consultation skills.
    • Excellent communication, presentation and facilitation skills.
    • Customer oriented, shopfloor oriented, data driven, pragmatic, passion for Continuous Improvement, result driven.
    • Advanced PC skills such as MS Office and Minitab.
    • Fluent in French and English (spoken and written).
    • Previous experience with Lean Transformations, Lean Assessment etc… is required

    If you’re interested in this position or if you would like to receive more information regarding this role, please apply or get in touch with Khephren Mongongu +41 43 508 29 16

  • Manufacturing

    Competitive
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    Skills Alliance is currently partnered with a multinational biotechnology company, leader in the fields of immunology and hematology. On behalf of our client, we’re currently recruiting for an Engineering Systems Specialist to join our client’s manufacturing site on a permanent basis.

    Purpose:

    The Engineering System Specialist is integrated in the Engineering Systems team. The scope of this position is to:
    •Create and improve the templates of engineering documentation including validation documentation
    •Create and improve engineering guidance to standardize the flow of the documentation and the validation requirements
    •Coordinate and Improve the structure engineering documentation repertory.
    •Coach partners of the engineering team to improve their documentation aspect
    •Write/Review project documentation drafted by engineers before the official validation review
    •Support engineering team for new projects according to GMP and Best Engineering Practices requirements.

    Scope of the function:

    •Filling and Packing Engineering and automation.
    •Purification / Utilities Engineering and automation.
    •HVAC and Facilities Engineering and automation.

    Major Accountabilities:

    •The incumbent is a validation expert supporting mechanical and automation engineering projects documentations (URS, Functional& design specifications, commissioning activities…)
    •Create and improve templates & guidance for Site Engineering activities (tenders, validation packages, …)
    •Support the redaction, coach engineers and review of documentations before Validation Agreement.
    •Recommend efficient improvement to qualify equipment and systems.
    •Coordinate engineering documentation activities to support the projects
    •Improve the department documentation structure.
    •Periodic review of Engineering procedures and forms to ensure alignment with local/divisional procedures
    •Assure strict compliance with cGMP, 21 CFRs, GAMP5, Corporate, Divisional and regulatory requirements
    •Support site activities as a technical professional to facilitate investigations

    Technical/Functional (Line) Expertise:

    He or She is able to understand all technical installations, equipment and systems used on the site.
    He or She is comfortable with the main requirement of validation for a new system or equipment.
    He or She is comfortable with technical documentation, engineering aspects, protocols and quality documentation to support all activities on site.
    He or She is perfectly aware of current validation divisional procedure.

    Leadership:

    He or She is also able to be factual to report problematics to management.
    He or She is able to analyze the current process and identify the improvements to do to simplify and standardize.

    Decision-making and Autonomy:

    He or She is able to report his or her final evaluation of technical choices inside projects core team.
    He or She will present this final evaluation to a final review for coaching by the manager or the senior engineer before presenting the final statement for agreement at the superior management level.

    Interaction:

    He or She is a collaborative and proactive member inside a team.
    He or She is sensitive and highly consider humans problematics to interact with other departments with demonstrated communication skills.

    Innovation:

    Leads benchmark and innovative ideas, propose innovation long term plan.

    Complexity:

    He or She have to take as a main priority EHS aspects inside all interventions on line.
    He or She is aware of the complexity of products manufactured, the complexity of aseptic aspects.
    He or She is also able to understand humans challenge complexity, to be able to respect any interlocutors by applying ethics code.

    Education / Experience Required:

    •Master’s degree in Biologics, Validation, Mechanics, Automation, Electrics: (Or bachelor’s degree with additional experience)
    •Comfortable with the technology evolution for automation systems.
    •5 years as a Validation Engineer with efficient technical skills.
    •Core Competencies / Skills / Leadership Behaviors:
    •Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.
    •Good communication, leadership and organizational skills
    •Has the ability to prioritize multiple tasks and work on multiple projects simultaneously
    •Client oriented, rigorous, synthetic and analytic thinking
    •Good written and verbal skills in French and English.
    •Must be sensitive to Data Integrity aspects.
    •Must be proficient with standard office software (Word, Excel and PowerPoint)

    If you are interested in or wish to know more about this position, please apply or get in touch with Khephren Mongongu +41 43 508 29 16.

  • Validation

    Competitive
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    Skills Alliance is currently partnered with a multinational biotechnology company, leader in the fields of immunology and hematology. On behalf of our client, we’re currently recruiting for a CSV Engineer to join our client’s manufacturing site on a permanent basis.

    Responsibilities

    The Validation Engineer II performs qualification / validation activities linked to his/her part of the business (Computerized Systems Validation). He/She prepares and implements the validation documentation required to assure the proper development of a project. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    1) Prepare and implement the validation documentation required to assure the proper development of a project.

    2) Act as a validation representative for projects, with support of his/her Validation Supervisor: Define and implement all validation activities related to the project. Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor.

    Provide validation expertise for the development of the project. Conduct the risk assessment related to the project.

    Review the URS, FS, DS and DR. Prepare the DQ. Review the commissioning protocols and reports to ensure leveraging into qualification.

    Prepare the IQ, OQ & PQ protocols. Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)

    Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system. Assure feedback of status and issues to the Validation Supervisor.

    3) Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

    4) Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    5) Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.

    6) Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file.

    7) Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfilmentand EHS.

    Requirements

    Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline

    Minimum 2 years of experience in Validation/Quality systems Skills: Project management experience

    Excellent communication skills, fluent in French and good knowledge of English (written and spoken)

    Familiar with Quality Management and GxP Regulations. Knowledge of Validation Methodologies Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP. Knowledge of the manufacturing processes.

    Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Sound industry knowledge, project proficiency, and autonomy expected.

  • Project Management

    Competitive
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    The Project Manager – System Owner is in charge of managing a Package of equipment/systems from Design to Hand-Over and the team members dedicated to this package.

    She/He performs the Engineering tasks necessary for the proper functioning of the equipment/systems she/he is in charge of.

    Function and Responsibilities:
    You will be in charge of the Design, Commissioning, Qualification (if required) and Hand-Over for the designated package of equipment/systems according to our client’s scope agreement.

    Your main tasks will be:
    • To deliver and be the owner for the technical documentation linked to your equipment/systems (ex. URS, PFD, P&ID, etc…). You are responsible for their inputs, updates, availabilities and changes.
    • To make the financial follow-up for your designated package according to the scope of agreement.
    • To schedule all activities for your designated package according to the scope of agreement.
    • To be the main person of contact with the suppliers, coordinate the equipment’s activities availabilities from FAT/SAT until hand-over to the final users.
    • To be accountable for all activities happening on the field according to information discussed during technical meetings.
    • To make sure that all information is given in order to update the Overview Planning.
    • To ensure that all technical documentation is completed on time.
    • To coordinate C&Q activities with suppliers and Commissioning /Qualification Engineers.
    • To anticipate all activities (reception to hand-over) for your package according to the scope of agreement.
    • To be accountable to deliver documentation and activities follow up to your Quality partner in order to maintain KPI’s
    • To work as C and Q team member’s supervisor including mission follow up, holidays and day off management, workload supervision, planning supervision and training follow up for commissioning and qualification activities
    • To insure the change management according to the Change control system in place.

    Qualifications:
    • 5 to 7 years’ experience in the Biotech/Pharmaceutical manufacturing Industry
    • Engineering educational background preferably in Chemistry, Bioprocessing or technical engineering
    • Good organization and communication skills
    • Good knowledge of Biotech/Pharma Utilities systems and/or Biotech equipment and experience in automation systems
    • Good knowledge of risk assessment and control
    • Good knowledge of Construction & Design is a plus
    • Fluent in English and French
    • Travelling may be required
    • Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP practices

    If you would like to know more about this position, please apply or get in touch with Khephren Mongongu +41 43 508 29 16.

  • Quality

    Rémunération Competitive
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    Skills Alliance recrute pour le compte d’une multinationale biopharmaceutique active dans le domaine de l’hématologie. Pour le site de production de notre client basé en Suisse Romande, nous sommes à la recherche d’un/d’une Chargé(e) de Qualité Opérationnelle (CDI).

    Votre mission

    Dans cette fonction, vous serez responsable de l’Assurance Qualité dans le cadre des activités tout au long des processus de production et de libération. L’expert en Assurance Qualité est le représentant Assurance Qualité pour les activités de routine BPF (Bonnes Pratiques de Fabrication) et les projets de notre client. Il/elle assurera la qualité des informations dans les systèmes et la documentation en ce qui concerne les directives, la conformité et les exigences réglementaires actuelles. La participation aux audits BPF fera partie des activités. L’expert en Assurance Qualité fera la promotion et sera impliqué dans l’amélioration continue.

    Responsabilités principales

    • Participer aux activités quotidiennes liées à la revue des dossiers de lot et des données associées pour la libération des lots en zone aseptique
    • Participer à la revue et évaluation des demandes de changement (”change control”) selon les procédures, méthodes, systèmes qualité et des dossiers règlementaires applicables pour répondre aux exigences du siège social, divisionnelles et règlementaires
    • Fournir le support QA aux activités de maintenance et des installations
    • Maintenir le ”mapping” organisé des variants de procédés (les codes produits)
    • Apporter du support quant à la résolution des problèmes/des causes à l’origine des déviations et CAPA
    • Exécuter les audits GMP internes en zone de production
    • Être un leader dans l’implémentation des projets du site en accord avec les exigences réglementaires et le département Qualité

    Profil recherché

    • Diplôme en Ingénierie, Biotechnologie, Pharmacie ou « Quality Management » appliqué aux procédés industriels ou expérience équivalente dans des sociétés pharmaceutiques et /ou biotechnologiques.
    • 4+ années d’expérience en Assurance Qualité ou en Contrôle Qualité
    • Connaissance des réglementations FDA, EMA, ICH, Pharmacopées et des normes système Qualité.
    • Connaissance des audits et inspections selon les normes règlementaires / qualité.
    • Expérience avec la disposition de produit.
    • Maitrise du français et niveau B2 en langue anglaise

    Pour recevoir plus d’informations sur cette offre, veuillez postuler ou contacter Khephren Mongongu au +41 (0) 43 508 29 16.

  • Quality

    £25000 - £30000 per annum
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    Senior QA Officer

    I am currently exclusively partnering with a very exciting pharmaceutical company who are currently looking for a Senior QA Officer to join their growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in developing and managing quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, offering excellent long-term prospects.

    Responsibilities:

    • To prepare and update SOPs
    • To make sure relevant personnel is trained on new SOPs
    • To prepare and review product quality reviews
    • To prepare monthly summary

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Medical affairs

    £65000 - £75000 per annum, car allowance + bonus
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    Senior Compliance Officer – Brand new role, brand new team

    I am currently working with a client of mine who are looking for an addition to their small compliance team. This is a brand-new team, and so you will be joining as part of a new role within the team and will play a pivotal role in championing compliance across the business.

    My client are specialists across various therapeutic areas and are building a compliance team that can promote the vision of compliance across the company.

    For this position, my client is looking for someone who has experience in a healthcare compliance role. You must have an excellent understanding of the ABPI and IPHA codes of practice. You will be working as part of the compliance team to ensure that these codes of practice are adhered to and you will be the point of contact for compliance in the company.

    Although this is a UK and Ireland role, this position will give you the opportunity to work closely with the EU affiliates as well as working closely with other functions within the company such as sales and marketing and regulatory affairs, as well as medical affairs.

    This is a great opportunity for anyone looking to take the next step in their career and is perhaps looking for a position in which they can take on a wealth of experience and be part of a growing team, with opportunities for growth in the future.

    For more information, please contact Chanel Hicken on 0207 220 6206 for a confidential discussion.

  • Regulatory

    Competitive + Benefits
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    Skills Alliance are currently partnering with a growing SME Biotechnology company with a focus on Research & Development of new Oncology drugs to combat forms of cancer with unmet needs in the marketplace.

    With successful commercialised products already on the market and promising results from their current clinical trials in relation to some of their key assets they are looking to appoint a Regulatory Affairs, Snr Manager to join their growing Regulatory Affairs team.

    This position is focused on assisting with CTA submissions but will also have cross functional elements allowing the appointed individual the potential to get involved with other regulatory functions such as MAAs and CMC.

    The main responsibilities held by the post holder will be:

    • Responsible for the preparation of clinical trial application regulatory submissions in compliance with global requirements. These will include EU documents such as initial CTAs and their accompanying IMPD, as well study/IMPD amendments, global documents such as IB updates and US documents such as IND safety report submissions.
    • Review and approve CTA related regulatory submissions, and support compliance check of regulatory approvals being in place prior to study site initiations and investigational product being provided.
    • Define and implement submission plans in conjunction with regulatory PT lead, clinical trial sub-team members, and participate in sub-team meetings to provide regulatory expertise and status updates.
    • Represent RA at clinical trial sub team meetings, identify needs and issues to the cross functional team.
    • Liaise with CRO regulatory contact, managing information/document needs and exchanges, agree upon submission strategy, ensuring the CRO is clear upon company deadline expectations.
    • Utilise CRO regulatory contacts to seek regulatory intelligence that will be beneficial to sub team discussions and strategy, maintaining regulatory relationships with counterparts.
    • Contribute to quality management, implementation of best practices and SOPS for CTA related activities.
    • Work with cross-functional team members to resolve issues raised either internally or by Health Authorities to ensure a rapid and efficient resolution.
    • As a member of the global regulatory affairs team, contribute to process improvements, and inspection readiness amongst the department.
    • Maintain up to date knowledge of CTA related regulatory requirements and communicate in a timely manner any updates that may impact into the development programmes.
    • Develop and maintain CT regulatory intelligence data particularly related to oncology products.
    • Plan & schedule own activities as well as those of the RA Clinical Trial group members.
    • Support non-CT related RA project work as requested.

    The ideal candidate profile will hold an MSc or PhD in a Life Sciences degree and 6 years relevant industry experience within a Pharmaceutical, Biotechnology or CRO environment.

    As a growing organisation, they are always keen to offer incoming employees the scope to evolve and develop and will offer the opportunity to work cross functionally to support continual personal development.

    The package on offer is very competitive in relation to the market and the client is also flexible on home working.

    If this position looks to be of interest, apply now to discuss further.

  • Quality

    £36000 - £46000 per annum
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    QA Team Leader

    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a QA Team Leader position.

    You would be part of a well-established and well-known Pharma organisation, where you will get the chance to supervise and manage an entire quality team. As the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Work closely with the Quality Systems department
    • Support self-inspections/internal audits and customers’ audits
    • Generate PPQR data in readiness for assessment and approval
    • Ensure staff are always trained

    Requirements:

    • Minimum 3 years of relevant experience
    • Previous managerial experience
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Team Leader position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • Quality

    £50000 - £65000 per annum
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    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Regulatory

    £40 - £45 per hour
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    Skills Alliance are partnering with a very exciting Biopharmaceutical Company who are focusing on bringing their licensed products in the US across to the LATAM and MENA regions. They need a strong Senior Regulatory Affairs Associate who is able to support to the cross functional team with initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals.

    This will be a 3 day a week contracting position for 12 months initially to be based in Oxford and an excellent rate on offer.

    Please Contact: shakir.hossain (at) skillsalliance.com

    For your ease please attached your CV to the application.

  • Quality

    £35000 - £45000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Clinical Development

    £70000 - £90000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are retained on a unique opportunity with an innovative Biotech.

    The company has an exciting pipeline in both early and late phase research, they work in areas of unmet need and are progressing quickly to commericalisation. They work in a cutting edge and very exciting space in research.

    The Director, Project Management is a new role and will facilitate the successful delivery of several R&D programs associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation and strong CMC and manufacturing experience. Cross-functional PM experience is required and ideally line management experience.

    This is a full-time and permanent position which can be pre-dominantly home-based, going into the office a few days per week. There would be some travel to the R&D and Manufacturing sites. They will offer a very competitive salary – circa £70-90K depending on experience + full benefits package.

    Skills Alliance are the preferred partner for this role so please get in touch for more details, contact Mark Anderson on 0207 220 6209.

  • Quality

    Competitive + Benefits
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    An expanding Sterile manufacturing company are currently looking to appoint a Quality Director. Already possessing an impressive portfolio they intend to develop this further with their current pipeline making this position pivotal in being able to fulfil this strategy.

    You will be working alongside the Managing Director and be responsible for directing and implementing strategies across the business. You will also be responsible for ensuring compliance with regulatory requirements and managing the internal compliance programs associated with the entire product lifecycle. Experience with QMS management, internal and external audits including site inspection readiness by the FDA & MHRA are essential.

    The main responsibilities of this position will be:

    • Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary other Senior Executives and Non-Executives.

    • Oversee the internal GMP and quality system audit program for all products.

    • Design, implement, and administer a management escalation process to ensure appropriate issues are elevated for management awareness and intervention.

    • Facilitate the management review process with executive management.

    • Ensure the quality and compliance of all required regulatory notifications.

    • Communicate with regulatory bodies as necessary and host regulatory inspections, as necessary.

    • Monitor the external FDA & MHRA regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance.

    • Develop and sustain a high performing team of direct reports, with attention to development and succession planning.

    • As a member of the Executive Team, contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing Development analysis and guidance on all activities, plans, targets and business drivers.

    • To grow and develop the business through the identification and progression of opportunities and by establishing strategic collaborations and interactions with third parties including public and private sector bodies.

    • To lead and manage the business, via a management team, to secure the delivery of high-quality products/services in an effective and timely fashion.

    • To deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness.

    • To report on the business and performance of Quality as required to the Board and others.

    • To take responsibility for all HR issues within the division.

    • To actively contribute to the development and achievement of translational and other programmes.

    • To take Executive responsibility for Health and Safety across the company.

    • To contribute to publications in national and international journals as appropriate.

    If this position looks to be well aligned to your skill set, apply now in order to discuss the opportunity further.

  • Clinical Development

    £70000 - £90000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative Biotech.

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    The company has an exciting pipeline in both early and late phase research, they work in areas of unmet need and are progressing quickly to commericalisation. They work in a cutting edge and very exciting space in research.

    The Director, Project Management is a new role and will facilitate the successful delivery of several R&D programs associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation and strong CMC and manufacturing experience. Cross-functional PM experience is required and ideally line management experience.

    This is a full-time and permanent position which can be pre-dominantly home-based, going into the office a few days per week. There would be some travel to the R&D and Manufacturing sites. They will offer a very competitive salary – circa £70-90K depending on experience + full benefits package.

    Skills Alliance are the preferred partner for this role so please get in touch for more details, contact Mark Anderson on 0207 220 6209.

  • Quality

    £35000 - £40000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Finance

    £450 - £500 per day
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    Skills Alliance are partnered with a leading, global pharmaceutical organisation. As part of a multinational process transformation programme affecting various corporate service functions such as finance, procurement, supply chain and HR. As part of this programme, they are now seeking an experienced Trading Manager on an inital 6 month contract.

    This will be remote role, however may revert to office-based in Surrey and require international travel on occasion.

    Role Purpose:

    This position sits within the organisations trading entity, responsible for overseeing and liaising with Financial Accounting, Management Accounting, Compliance (Financial and Other), logistics, financial systems and process duties for the activities around the sale of product.

    The department is core legal entity within an EMEA Group and the results have a fundamental impact on the company strategy and group P&L, through the appropriate use of Transfer pricing, Marketing Right ownership and Marketing activities.


    Responsibilities:

    • Conduct financial/management accounting, JSOX compliance, logistics, and process duties for activities around the sale of products to EMEA affiliates and 3rd party distributors.
    • Provide commercial oversight to ensure appropriate governance and that transactions flow in accordance with API’s Tax & Transfer Pricing strategy and with EU tax legislation.
    • Work collaboratively across functions (including Other Group Trading & IP Holder Companies, API Finance, API Tax, European Tax, EUTD, Commercial Finance, EMEA Business Services).
    • Operate as an effective Finance Business Partner to internal and external stakeholders, collaborating to make effective decisions, and adding business value where possible.
    • Deliver timely and accurate financial reporting both internally and externally.
    • Apply initiative and commercial judgement to resolve problems, making timely decisions to support time sensitive commercial goods and services movement.
    • Work collaboratively as a member of the Finance team, contributing to overall performance through value add activities.
    • Interact with process owners and oversee transactional activities as executed by Finance teams.
    • Influence trading strategy across various trading entities and affiliates.
    • Provide support to decision-making around trading strategy and provide insight through partnering with other entities and affiliates.

    Required Experience:

    • Pharma sector experience with strong customer focus; in multi-disciplinary, matrix and cross-cultural settings.
    • Track-record of leading planning process with excellent organisational, collaboration and people management skills.
    • Demonstrable sustained finance experience within Finance functions
    • Proven compliance expertise; understanding and complying with industry laws and relevant regulations.
    • Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
    • Demonstrable examples of ability to develop, coach and enable high performance teams and proactively promote best practice and knowledge sharing.
    • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
    • Sound commercial awareness and ability to contribute to the success and development of the finance function and business in general
    • Audit experience preferable
    • Degree qualified, with post-grad accounting qualifications (ACA, ACCA)

    Plus demonstrable experience/exposure to a majority of the following areas:

    • Inventory knowledge – accounting/transactional knowledge/best practice
    • Financial Modelling & Analysis
    • Preparation of Management Reports
    • Preparation of Budgets & Forecasts
    • Variance Analysis including understanding of cost drivers, volume & pricing
    • Month End Close Process
    • UK GAAP, IFRS and group accounting experience
    • Internal Controls & process compliance work
    • Hands on use of Accounting & Reporting tools such as SAP, HFM
    • Liaison with auditors & professional advisors
    • Must have experience of working across multiple sites and localities
  • Clinical Development

    £60000 - £80000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Regulatory

    Competitive + Benefits
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    Skills Alliance are currently partnering with a growing SME Biotechnology company with a focus on Research & Development of new Oncology drugs to combat forms of cancer with unmet needs in the marketplace.

    With successful commercialised products already on the market and promising results from their current clinical trials in relation to some of their key assets they are looking to appoint a Regulatory Affairs, Snr Manager to join their growing Regulatory Affairs team.

    This position is focused on assisting with CTA submissions but will also have cross functional elements allowing the appointed individual the potential to get involved with other regulatory functions such as MAAs and CMC.

    The main responsibilities held by the post holder will be:

    • Responsible for the preparation of clinical trial application regulatory submissions in compliance with global requirements. These will include EU documents such as initial CTAs and their accompanying IMPD, as well study/IMPD amendments, global documents such as IB updates and US documents such as IND safety report submissions.
    • Review and approve CTA related regulatory submissions, and support compliance check of regulatory approvals being in place prior to study site initiations and investigational product being provided.
    • Define and implement submission plans in conjunction with regulatory PT lead, clinical trial sub-team members, and participate in sub-team meetings to provide regulatory expertise and status updates.
    • Represent RA at clinical trial sub team meetings, identify needs and issues to the cross functional team.
    • Liaise with CRO regulatory contact, managing information/document needs and exchanges, agree upon submission strategy, ensuring the CRO is clear upon company deadline expectations.
    • Utilise CRO regulatory contacts to seek regulatory intelligence that will be beneficial to sub team discussions and strategy, maintaining regulatory relationships with counterparts.
    • Contribute to quality management, implementation of best practices and SOPS for CTA related activities.
    • Work with cross-functional team members to resolve issues raised either internally or by Health Authorities to ensure a rapid and efficient resolution.
    • As a member of the global regulatory affairs team, contribute to process improvements, and inspection readiness amongst the department.
    • Maintain up to date knowledge of CTA related regulatory requirements and communicate in a timely manner any updates that may impact into the development programmes.
    • Develop and maintain CT regulatory intelligence data particularly related to oncology products.
    • Plan & schedule own activities as well as those of the RA Clinical Trial group members.
    • Support non-CT related RA project work as requested.

    The ideal candidate profile will hold an MSc or PhD in a Life Sciences degree and 6 years relevant industry experience within a Pharmaceutical, Biotechnology or CRO environment.

    As a growing organisation, they are always keen to offer incoming employees the scope to evolve and develop and will offer the opportunity to work cross functionally to support continual personal development.

    The package on offer is very competitive in relation to the market and the client is also flexible on home working.

    If this position looks to be of interest, apply now to discuss further.

  • Clinical Operations

    Competitive
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    Skills Alliance is currently partnered with the leading global medical device company based in the central German part of Switzerland. For this purpose, our client is looking for a Senior Clinical Trial Manager to join their team on a permanent basis.

    Job Title: Senior Clinical Trial Manager

    Job Type: Permanent


    Job Description:

    The Senior Clinical Trial Manager is a full-time position that independently implements and oversees all areas of clinical trial management in Europe, North America or other regions as needed. This includes, but is not limited to, managing day-to-day activities including trial start-up, conduct, and closeout activities on (multiple) clinical trials as well as management of vendors such as Contract Research Organizations (CROs) and/or investigative sites. The Sr. Clinical Trial Manager is highly self-motivated, pro-active and flexible. This position is field-based and reports to the Director of Clinical Operations.

    Essential Duties & Responsibilities:

    • Consistently implement and successfully completes clinical research operations in global clinical trials.
    • Ensure that the assigned clinical trials are conducted in accordance with internal Standard Operating Procedures, Good Clinical Practice regulations as well as applicable country’s regulations
    • Managing the completion of routine and advanced trial start-up, conduct, and close-out activities to industry and corporate standards, with support from a senior member of the clinical operations team
    • Manages and works effectively with CROs and other vendor partners
    • Establishes and maintains sound clinical and data collection practices to ensure validity of studies
    • Assisting with (or leading, when necessary) the writing of clinical documents such as informed consents, trial reports, and annual reports
    • Follow up and implement clinical site contracts and budgets
    • Responsible for the evaluation and selection of investigative sites
    • Ensuring that the progress and completion of trial(s) are in-line with the agreed upon trial goals/ targets such as enrollment, active sites and other milestones, as determined by the manager
    • Planning, Implementing and tracking of trial timelines and budgets
    • Managing most aspects of trial operations including vendor performance, internal metrics, and communication of trial status within and outside the trial team
    • Train and mentor clinical operations team members such as junior CTM and CRAs.
    • Lead the preparation and follow-up of in-house and on-site sponsored quality audits, co-monitoring visits with CRO monitors, as well as, regulatory authority inspections.
    • Organize and participate in investigational meetings and site training representing assigned clinical trial
    • Preparing and presenting trial specific updates to management and cross functional areas
    • Manages Clinical Operations team members to appropriate and timely completion of projects
    • Ensure activities comply with the applicable Quality System requirements
    • Assume any other activities and responsibilities as assigned

    Required Skills & Competencies:

    • Familiarity with clinical research in Oncology
    • Strong critical thinking and problem solving skills
    • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
    • Excellent organizational and record-keeping skills
    • Ability to maintain excellent working relationships with a broad range of trial staff internally and externally
    • Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
    • Ability to work well in a team environment but also independently without significant oversight
    • Experience in clinical budget planning, management, and reconciliation required; forecasting experience preferred.
    • Prior experience with electronic data capture (EDC) preferred
    • Experience interfacing and managing multiple vendors/contractors.
    • Strong initiative and positive attitude.
    • Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information.
    • Flexibility in work hours and readiness to travel abroad on as needed basis
    • Fluency in English (verbal and written) and excellent communication skills
    • Advanced computer literacy

    Qualifications:

    • Bachelor’s degree in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school preferred
    • Minimum 5-7 years of experience in a clinical trials management role in the device, biotechnical and/or pharmaceutical industry monitoring and managing clinical trials. Device experience preferred or trial management in a biotech/start-up environment.
    • Minimum of 6 years’ experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
    • 5-7 years of oncology experience preferred
    • Oncology solid tumor experience preferred
    • Accredited GCP course desirable
    • Past experience in an administrative position desirable

    Other:

    • Average travel commitment of 25-30%, which includes overnight travel as needed (United States and abroad)
    • Ability to lift up to 20 pounds

    If you are interested or you know someone who would be interested please apply directly here or feel free to contact Heena Verma via phone @ +41 44 798 2410.

    Thanks!

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    £600 - £700 per day
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    Skills Alliance are supporting a global pharmaceutical organisation with an ongoing procurement transformation programme. As part of this programme, they are implementing a brand new P2P solution across their global business.

    Within this project team, they require an experienced P2P Change Management professional to join on an initial 12 month contract.

    Job Purpose:

    • To lead change initiatives across the global P2P implementation.
    • Manage stakeholder expectations across a wide range of internal functions up to a senior level – This may include leadership across procurement, finance, IT, compliance, legal, to name a few.
    • Manage the relationship with external 3rd parties supporting the implementation.
    • Be the point of contact and subject-matter expert on any changes to processes, system differentiators between old and new.
    • Ensure key individuals and functional users are content with changes, along with managing timeline expectations.

    Required experience:

    • A proven track record managing several P2P implementations is essential, either as a change manager or project manager in job title. A project manager will need to have a strong focus on change/transformation.
    • Tier-1 P2P system experience – SAP Ariba, Oracle e-fusion, Coupa, or equivalent level.
    • Global P2P system implementation experience is required.
    • Demonstrable experience working in a complex, matrix-structured organisation.

    Note: Due to current restrictions, this will be a remote-based role until further notice.

    Please get in touch with Jim Bellicoso at Skills Alliance for further information! jim.bellicoso@skillsalliance.com.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Regulatory

    £50000 - £60000 per annum
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    Regulatory Affairs Executive

    My client is currently looking for someone to join their team as a Regulatory Affairs Executive and be responsible for UK specific regulatory oversight on marketed products.

    This is a great opportunity for someone looking to enhance their knowledge and experience on QRVI systems and processes, as well as representing the Regulatory function and contributing with advice on different strategies to improve quality performance.

    Responsibilities:

    • Advising on local strategy procedures
    • Acting as the primary regulatory liaison between MHRA and OPUK
    • Submission of variations to the MHRA ensuring maintenance of regulatory databases
    • Organise internal audits for the affiliate

    Requirements:

    • Degree in Pharmacy or life science degree
    • Good knowledge of QMS, GDP, GMP, GCP, Regulatory
    • Experince in interacting with the MHRA
    • Excellent attention to detail and flexible approach

    This is a site-based position in Berkshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £40000 - £50000 per annum
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    QMS Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QMS Specialist.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop systems and establish procedures for documentation
    • Ensure that current QA documentation is in line with relevant requirements
    • To provide direct Quality team support during audits and inspections
    • Provide Quality systems and training

    Requirements:

    • Experience with HTA is essential
    • Experince within GMP environment
    • Knowledge and expertise in the QMS processes
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Medical affairs

    £40000 - £50000 per annum, bonus
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    Medical Information and PV Officer – Hybrid Role – Global Pharma

    I am currently working with a client of mine who are looking for a medical information and pharmacovigilance officer to join their team.

    My client are a globally renowned pharmaceutical company, well known for their work within the cardiovascular and oncolog therapeutic areas. They are a mid-sized company, continually growing and are invested in the development of their employees giving this person ample opportunity to progress within the business.

    For this position, my client is ideally looking for someone who is experienced in both medical information and pharmacovigilance. Your responsibilities will include responding to first and second line enquiries as well as carrying out copy approval. With this in mind, copy approval experience is essential.

    This role will also encompass responsibilities such as working with European affiliates to ensure policies are in line with ABPI, EFPIA and IPHA codes of practice so this is a great role allowing you to take on EU exposure.

    As part of the pharmacovigilance responsiblities, you will be deputy local safety officer, responsible for a breadth of pharmacovigilance duties such as reporting ADRs, training junior PV staff in the team as well as proof-reading SMPCs and PILs to ensure compliance with safety data.

    This is a great role for anyone with some experience in a similar role to this to step up and take on more responsibilities to further your career.

    For more information on this position or any similar opportunities, please contact Chanel Hicken on 0207 220 6206.

  • Quality

    £30000 - £40000 per annum
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    Senior Quality Associate

    Currently partnering with a leading global contract service company who are currently looking for a Senior Quality Associate to join their rapidly growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in Good Manufacturing Practice to develop and manage quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To liaise with project teams as a key quality contact
    • To provide advice to cross-functional teams
    • To ensure SOPs are up to date
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To perform risk assessments

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Commercial

    Competitive
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    As a Training & Development Manager for you will be responsible for the delivery of training across the UK, Ireland, Nordics & Netherlands Teams.

    The role will see you leading product training for several new indications of the product portfolio, including adapting regional programmes; working closely with the Sales Forces to identify training / development needs and put in place suitable solutions as well as designing & delivering soft skills training. The role will see you working with internal stakeholders across all levels as well as where required outsource partners for learning solutions.

    You will have a proven track record in delivering training within a Pharmaceutical industry setting. This should be beyond soft skills training and include specifically product / scientific based training.

    You experience will include some or all of the following:

    Good understanding of the ABPI code of Practice.
    Proven track record of delivering high quality training related work with tangible outcomes.
    Good understanding of speciality therapeutic areas
    Able to get on with others and be a team-player having the ability to work within a team and independently.
    Ability to function in and influence key stakeholders in matrix organisation.

    For more information on this opportunity or any similar opportunities, please contact Warda Issa or email your CV and we can arrange a time for a confidential discussion about your next career move.


    T: +44 (0) 203 823 4158

  • Quality

    £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £40000 - £50000 per annum
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    QMS Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QMS Specialist.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop systems and establish procedures for documentation
    • Ensure that current QA documentation is in line with relevant requirements
    • To provide direct Quality team support during audits and inspections
    • Provide Quality systems and training

    Requirements:

    • Experience with HTA is essential
    • Experince within GMP environment
    • Knowledge and expertise in the QMS processes
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £30000 - £40000 per annum
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    Senior Quality Associate

    Currently partnering with a leading global contract service company who are currently looking for a Senior Quality Associate to join their rapidly growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in Good Manufacturing Practice to develop and manage quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To liaise with project teams as a key quality contact
    • To provide advice to cross-functional teams
    • To ensure SOPs are up to date
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To perform risk assessments

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    £400 - £425 per day
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    Skills Alliance are working with a global pharmaceutical organisation, undertaking major change across their international business. As part of this programme, they are seeking an experienced P2P Business Analyst to support process change across their existing procurement systems.

    The Job:

    The global transformation programme across the business is aimed to standardise operating processes and deploy a global SAP IT platform. It includes:

    • One integrated set of master data
    • Finance & Accounting, Procurement, and Supply Chain operations
    • Core HR processes, KPIs and HR data management

    This role is key to the delivery of the EMEA solution, which at present is scheduled for completion in approximately March 2021 and will deploy to 28 countries.

    You will be required to provide core Business Analysist support in the following P2P areas:

    • Processes – SAP Concur T&E, Ariba Sourcing, Contracts and Supplier lifecycle performance, Ariba Guided Buying, Invoicing (Invoice Pro), Ariba Network (Supplier Onboarding), Supplier Master, SAP S/4 Hana
    • Business Audience – end users and requesters, approvers and managers, Outsourced operation teams, Finance and Procurement
    • Business Analysis / Change
    • Training and Change team support
    • Development of EMEA Business Roles permissions and transactions – from both an Ariba and SAP perspective – Effectively aligning the users to appropriate roles and responsibilities.


    Required Experience:

    • Strong P2P process, change and business analysis background preferred.
    • End User centric, approach with excellent verbal and written communication skills is required.
    • Solid practical knowledge of P2P in Ariba, SAP AP and some masterdata is required.
    • Degree educated
  • Regulatory

    COMPETITIVE
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    Skills Alliance are currently partnered with an innovative Biotech focusing on ATMPs who is looking for Sr. Regulatory Affairs Associates to join their growing team. They have been progressing well with early phase studies and have cutting edge programs in phase II.

    This position will report into the Director, Regulatory Affairs and will support in the development, review and execution of regulatory strategy within the regulatory sub-team and the delivery of regulatory activities/submissions necessary to support global product development and registration.

    Requirements:

    • Biological sciences degree
    • Up to 4 years’ experience in regulatory affairs
    • Experience of European and US regulatory affairs

    This role provides a rare opportunity to join at an exciting phase of growth.

    Please submit your CV if you are interested in discussing further.

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    Skills Alliance are currently partnered with an innovative Biotech focusing on ATMPs who is looking for Sr. Regulatory Affairs Associates – CMC to join their growing team. They have been progressing well with early phase studies and have cutting edge programs in phase II.

    This position will manage the CMC regulatory submissions throughout the lifecycle with minimum supervision, with responsibility for the authoring, reviewing, compiling and execution of all regulatory CMC submissions.

    Requirements:

    • Scientific background in ATMPs or biologics
    • A degree in Biosciences, Biochem, Chemistry would be a plus
    • Ideally worked in a small pharma/biotech environment
    • Experience working on Change Controls.
    • Someone who has pushed themselves out of their comfort zone to progress their career.

    This role provides a rare opportunity to join at an exciting phase of growth.

    Please submit your CV if you are interested in discussing further.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established SME Pharma. Permanent Clinical Study Manager role based from home initially but 3 days in Hertfordshire in the future.

    This SME Pharma work in Oncology and are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Lead CRA, Associate Study Manager or Regional Study Manager to join the team and will consider CRO or Pharma experience. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is home-based initially but will be office-based in Hertfordshire with flexibility further down the line. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established SME Pharma. Permanent Associate Clinical Study Manager role based from home initially but 3 days in Hertfordshire in the future.

    This SME Pharma work in Oncology and are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Lead CRA, Associate Study Manager or Regional Study Manager to join the team and will consider CRO or Pharma experience. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is home-based initially but will be office-based in Hertfordshire with flexibility further down the line. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Regulatory

    Competitive Salary
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    Regulatory Affairs Director

    I am currently partnered with a full-service clinical research organization to hire a Director, Regulatory Affairs to assist with the implementation of the regulatory strategy for specific projects.

    This position will facilitate interfacing between internal and external stakeholders of the organisation and being the main point of contact with all regulatory bodies, as well as being accountable for post-market application maintenance and activities. The Regulatory Affairs Director will also create and implement different regulatory strategies and will lead the regulatory staff working on specific projects and products, while assisting with all Regulatory matters.

    Responsibilities:

    • To lead and develop regional and global regulatory strategy
    • To monitor changes in the regulatory environment
    • To provide regulatory leadership in due diligence review projects
    • To manage relationships with competent authorities

    Requirements:

    • Advanced degree required
    • Minimum 8 years of experince of regulatory drug development and product approval
    • Strong strategic-thinking and organisational skills
    • Proven leadership and program management experince

    This is a permanent position based in the US, with a great salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru or Stephanie Khalife for more details on +4402036683961 or click APPLY NOW.

  • Manufacturing

    €700 - €850 per day
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    I am partnering with a global bio pharma who are seeking for a Process Automation Engineer to come in and support their current OPEX expanision projects. The ideal candidate will maintain and troubleshoot all process control system hardware and software (DeltaV DCS system) in support of the biopharmaceutical manufacturing process.

    • Over 5 years’ experience pharma/biotech experience (cGMP, GAMP5)

    • Experience with Delta V, MES Syncade

    • Biotechnology or batch pharmaceutical experience production experience

    • English essential, (English and German/French preferred)

    • Bachelor’s degree in an Engineering discipline (MSc preferred)

    Day rate – CHF 700 – 850 (depending on experience)

    If you are interested, please contact me via email:

    Email: botrus.audisho (at) skillsalliance.com
    +44 (0) 207 220 6237
    LinkedIn – Botrus Audisho

  • Quality

    £50000 - £65000 per annum
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    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    €240000 - €260000 per annum, Bonus + Stock Options
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    Skills Alliance is currently partnered with a multinational biotechnology company specialized in immuno-oncology. On their behalf, we’re currently recruiting for a permanent Head of Quality Assurance to lead our client’s manufacturing QA team in the canton of Vaud, Switzerland.

    This is a leadership role responsible to manage the Quality assurance activities of our client’s bio-manufacturing plant in line with cGMP regulations for clinical and commercial supply of biological APIs. The position will ensure Quality operational compliance to our client’s standards and international regulatory standards.

    Candidate requirements set out by our client:

    • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
    • Advanced degree strongly preferred with experience in Biotechnology
    • Must be fluent in French and English (the company language)
    • First-hand experience of minimum 12 years in a Quality managerial role in a biopharmaceutical manufacturing environment (upstream and downstream)
    • Thorough knowledge of biotechnological technologies, processes and clean utilities
    • Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation

    If you would like to know more about this position, please apply or get in touch with Khephren Mongongu +41 43 508 29 16.

  • Sales & Marketing

    £100000 - £115000 per annum, car allowance + bonus
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    Regional Sales Manager – Product Launch – Brand new role

    My client are an American company about to launch their first product in Germany following the product’s success in the US. As a company, they are focused on working in the cardivoascular therapeutic area with a specific focus on lipidology.

    As part of this role, you will be working as a Regional Sales Manager for Eastern Germany and will be managing a team of up to 10 key account managers (KAMs). You will also be responsible for implementing company strategy to ensure the business delivers to commercial targets. You will also contribute to the company’s sales plan for their product portfolio.

    This is a great role for anyone who is looking to take on a new challenge in a new team with a company that are establishing themselves across Europe, and you get to be involved with bringing a potential blockbuster drug to the European market in the field of cardiovasular/cardiology.

    For this position, my client is looking for someone who has experience in field sales, as well as management experience. Ideally, you will have managed teams of hospital sales reps and/or key account managers across a given region. Experience in the cardiovascular/cardiology therapeutic areas is a must.

  • Regulatory

    Competitive Salary
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    Regulatory Affairs Director

    I am currently partnered with a full-service clinical research organization to hire a Director, Regulatory Affairs to assist with the implementation of the regulatory strategy for specific projects.

    This position will facilitate interfacing between internal and external stakeholders of the organisation and being the main point of contact with all regulatory bodies, as well as being accountable for post-market application maintenance and activities. The Regulatory Affairs Director will also create and implement different regulatory strategies and will lead the regulatory staff working on specific projects and products, while assisting with all Regulatory matters.

    Responsibilities:

    • To lead and develop regional and global regulatory strategy
    • To monitor changes in the regulatory environment
    • To provide regulatory leadership in due diligence review projects
    • To manage relationships with competent authorities

    Requirements:

    • Advanced degree required
    • Minimum 8 years of experince of regulatory drug development and product approval
    • Strong strategic-thinking and organisational skills
    • Proven leadership and program management experince

    This is a permanent position based in the US, with a great salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +4402072206230 or click APPLY NOW.

  • Finance

    £400 - £425 per day
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    Skills Alliance are working with a global pharmaceutical organisation, undertaking major process change across their international business. As part of this programme, they are seeking an experienced Finance R2R Business Analyst. You will need to have SAP and R2R experience, operating as a business analyst within a global pharmaceutical organisation in order to be considered.

    The Job:

    The Business Analyst supports the rollout of the EMEA S4 release for 28 countries as part of the Finance transformation team. The programme is developing regionally standardised processes and improving the performance of the organisation to meet the process and system related programme objectives.

    Specifically:

    • Participate in the testing activities necessary to ensure the smooth deployment of the system.
    • Support the preparation for operational readiness and work with the affiliates to coordinate these activities.
    • Support the affiliates and the Enterprise Master Data team in data preparation and load.
    • Support the cutover of activities for go live.


    Required Experience:

    • At least two years experience with an EMEA, matrix structured environment, preferably in a support function
    • Deep knowledge of SAP financial systems is essential, as well as deep R2R process knowledge
    • Previous experience working for a Pharmaceutical organisation
    • Proven experience in complex process improvements and project delivery, formal qualification is an advantage
    • Proven experience in managing changes to SAP financial systems
    • Change management experience
    • Deep knowledge of process improvement methodology, formal qualification is preferable
    • Experience of working across multiple sites and nationalities
    • Shared services experience is an advantage
  • Pharmacovigilance

    Competitive
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    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Warda Issa for more details on +440203 823 4158 or click APPLY NOW.

  • Clinical Development

    £70000 - £90000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative Biotech.

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    The company has an exciting pipeline in both early and late phase research, they work in areas of unmet need and are progressing quickly to commericalisation. They work in a cutting edge and very exciting space in research.

    The Director, Project Management is a new role and will facilitate the successful delivery of several R&D programs associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation and strong CMC and manufacturing experience. Cross-functional PM experience is required and ideally line management experience.

    This is a full-time and permanent position which can be pre-dominantly home-based, going into the office a few days per week. There would be some travel to the R&D and Manufacturing sites. They will offer a very competitive salary – circa £70-90K depending on experience + full benefits package.

    Skills Alliance are the preferred partner for this role so please get in touch for more details, contact Mark Anderson on 0207 220 6209.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established SME Pharma. Permanent Clinical Study Manager role based from home initially but 3 days in Hertfordshire in the future.

    This SME Pharma work in Oncology and are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Lead CRA, Associate Study Manager or Regional Study Manager to join the team and will consider CRO or Pharma experience. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is home-based initially but will be office-based in Hertfordshire with flexibility further down the line. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established SME Pharma. Permanent Associate Clinical Study Manager role based from home initially but 3 days in Hertfordshire in the future.

    This SME Pharma work in Oncology and are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Lead CRA, Associate Study Manager or Regional Study Manager to join the team and will consider CRO or Pharma experience. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is home-based initially but will be office-based in Hertfordshire with flexibility further down the line. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Quality

    £30000 - £40000 per annum
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    Skills Alliance are partnered with a client who is on the front-line of fighting Covid-19 and currently supporting them with hiring a team of 3x QA Analysts on a 6-12 month FTC to work on this exciting project.

    The ideal candidates must be:
    • Familiar with UK quality system ISO 15189
    • Experienced in performing Lab Audits
    • Experienced in maintaining QMS and Document Control Systems

    This role will be day shift Monday to Friday only, though some flexibility may be needed on occasion.

    This position is a fixed term 6-12month position (depending on candidate preference). Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +44 (0) 20 7220 6230 OR click APPLY NOW for more information.

  • Quality

    £30000 - £40000 per annum
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    Share

    Skills Alliance are partnered with a client who is on the front-line of fighting Covid-19 and currently supporting them with hiring a team of 3x QA Analysts on a 6-12 month FTC to work on this exciting project.

    The ideal candidates must be:
    • Familiar with UK quality system ISO 15189
    • Experienced in performing Lab Audits
    • Experienced in maintaining QMS and Document Control Systems

    This role will be day shift Monday to Friday only, though some flexibility may be needed on occasion.

    This position is a fixed term 6-12month position (depending on candidate preference). Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +44 (0) 20 7220 6230 OR click APPLY NOW for more information.

  • Clinical Development

    £60000 - £80000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
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    Share

    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Job
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    Share

    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have had excellent results from early phase trials. The company is growing quickly and have advanced therapies trials that are progressing well. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the office in the London area when they can return to the office. They offer an excellent salary – circa £50-60K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Quality

    £30000 - £40000 per annum
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    Share

    Skills Alliance are partnered with a client who is on the front-line of fighting Covid-19 and currently supporting them with hiring a team of 3x QA Analysts on a 6-12 month FTC to work on this exciting project.

    The ideal candidates must be:
    • Familiar with UK quality system ISO 15189
    • Experienced in performing Lab Audits
    • Experienced in maintaining QMS and Document Control Systems

    This role will be day shift Monday to Friday only, though some flexibility may be needed on occasion.

    This position is a fixed term 6-12month position (depending on candidate preference). Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +44 (0) 20 7220 6230 OR click APPLY NOW for more information.

  • Clinical Operations

    £70000 - £90000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative Biotech.

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    The company has an exciting pipeline in both early and late phase research, they work in areas of unmet need and are progressing quickly to commericalisation. They work in a cutting edge and very exciting space in research.

    The Director, Project Management is a new role and will facilitate the successful delivery of several R&D programs associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation and strong CMC and manufacturing experience. Cross-functional PM experience is required and ideally line management experience.

    This is a full-time and permanent position which can be pre-dominantly home-based, going into the office a few days per week. There would be some travel to the R&D and Manufacturing sites. They will offer a very competitive salary – circa £70-90K depending on experience + full benefits package.

    Skills Alliance are the preferred partner for this role so please get in touch for more details, contact Mark Anderson on 0207 220 6209.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Job
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    Share

    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £300 - £400 per day
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    I am looking to speak with contractors to be mainly responsible for country management for sites within the EU (approx. 6 countries). My client is a biopharmaceutical company that develops and commercializes anti-cancer agents in the US and internationally.

    The company’s lead product includes an oral small molecule inhibitor of poly ADP-ribose polymerase used for the treatment of adults with BRCA mutation associated metastatic castrate-resistant prostate cancer.

    Its major pipeline products is intended for the treatment of ovarian cancer, prostate cancer, gastric cancer and solid tumors with mutations in homologous recombination repair genes. The company’s preclinical candidate, is a peptide-targeted radionuclide therapy and imaging agent intended for the treatment of cancer.

    Education and Experience
    · Bachelor’s degree in a scientific discipline or health-related field.
    · Minimum of 4 years clinical research experience and at least 2 years’ experience as a Study Management Associate, or equivalent role, in a biopharmaceutical company or CRO.
    · Previous experience with Global oncology clinical trials is strongly preferred.
    · Previous site monitoring experience performing site Qualification, Initiation, Interim and Close-Out Visits a plus.

    If intrested please send me a copy of your CV for consideration and I hope to speak with yoiu soon.

  • Scientific

    £40000 - £44000 per annum, Night Shift Allowance
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    Skills Alliance are currently partnered with a client who is on the front-line of fighting COVID-19 and are currently supporting them with hiring for a Laboratory Supervisor.

    This position will reporting into the Laboratory Manager and will be focused on supervising a team of approximately 20 people. The ideal candidate will have previous experience as a Supervisor in a clinical laboratory setting. In addition to, experience in RNA Extraction and ideally with LIMS.

    Qualifications:
    • Bachelor’s degree in biology or related scientific discipline
    • Minimum of 5 years of clinical molecular experience.

    Please note you may be requested to work shifts other than daylight depending on the needs of the laboratory. Weekend work may be required.

    This is a 12 month fixed term contract. If you are interested in learning more, please submit your CV for consideration.

  • Clinical Development

    £60000 - £80000 per annum, Excellent package
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    Share

    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
    Apply

    Job
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    Share

    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have had excellent results from early phase trials. The company is growing quickly and have advanced therapies trials that are progressing well. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the office in the London area when they can return to the office. They offer an excellent salary – circa £50-60K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Medical Devices

    Competitive
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    My reputable client are looking for an experienced App Developer to join their young innovative team to be part of a forward thinking MedTech Company. They are an ambitious company at the forefront of Digital Transformation and supports Digitalization within the niche of the Life Science Market. In order to support their growing client base they are recruiting a Strong Application developer.

    This person should have excellent knowledge of Application Development across iOS and Android Platforms with a number of completed/developed products in their portfolio. Ideally this person should have strong Project Management/Technical Lead ablities – to support upscaling of the Application Development team.

    This is a freelance role and due to the longer term nature of the company has the potential to extend. They are a really flexible business and can accommodate onsite or offsite working depending on your situation – an excellent rate is also on offer making this a fantastic opportunity overall.

    More junior app developers welcome to apply as they have an overall project where they can make multiple hires – ideally having worked within Regulated Development Projects previously.

    Join a young team who are passionate about Digital Health, and are establishing their market presence across Europe.

    If interested reach out to:
    amy.mchugh@skillsalliance.com
    Digital Transformation Consultant – Europe

  • Clinical Operations

    £60000 - £75000 per annum, Bonus + benefits
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    Great opportunity for an experienced Clinical Project Manager or Study Manager to join a niche Bitoech working in Oncology. The role would be home-based initially with some travel to the office when normality resumes.

    The role is with a niche company who are very innovative and work specifically in Oncology. The company is growing quickly and have exciting early phase programs ongoing. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence and Oncology trial management is essential for this role.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the London office further down the line. They offer an excellent salary in the region of £60-75K depending on expeirence + bonus + benefits.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Finance

    €120000 - €150000 per annum, Bonus + Company Car
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    On behalf of our client, a biopharmaceutical company with manufacturing operations in Wallonia (BE), we are currently recruiting for a Director of Finance. The overall responsibilities for this role will be to maintain and continuously improve all aspects of the financial management and reporting systems while strongly collaborating with site business partners to provide financial insight. This is a critical role within the site leadership team to facilitate and support the manufacturing operations.

    Preferred Requirements:
    • Master’s degree in finance or Accounting
    • 10 years operational finance experience in manufacturing operations
    • 8 years of people management experience
    • Strong working knowledge of financial and non-financial metrics and product costing
    • Ability to challenge the status quo with a continuous improvement mindset.
    • Proven ability in using a wide variety of lean tools
    • Fluent in English & French

    If you would like to receive more information regarding this opportunity, please apply or get in touch with Khephren Mongongu: +41 43 508 29 16

  • Procurement

    $150000 - $170000 per annum
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    Skills Alliance are partnering a global pharmaceutical organization based in Boston, Massachusetts. Currently expanding their procurement team, they are seeking an experienced Sourcing Manager to join their Vaccines business unit, working closing with R&D and manufacturing verticals. You will need to have at least 3 years sourcing experience, working closely with R&D and manufacturing business units, with a global pharmaceutical organization.

    Job Purpose:

    The Strategic Sourcing Manager is deep subject matter expert in 3-5 complex sub-categories. They will work with the Global Category Teams to deliver proactive procurement initiatives in line with the relevant category strategy and annual plan, and in doing so will be required to manage a very senior stakeholder network for complex categories.

    Key Responsibilities:

    • Delivering agreed targets through project implementation
    • Refining the scope of projects to enable delivery in line with the top down targets
    • Creating project plans, identifying required resources, identifying / creating all primary deliverables, and receiving sign off for all major gateways in line with the Category Management Framework
    • Implementing the agreed project plan and reporting on progress to relevant stakeholders
    • Collecting the supplier, market, category and internal business data and information required to inform project execution
    • Applying agreed Category Management Frameworks and ensuring project delivery is aligned to the long-term category strategy, sub-category strategy, business needs and priorities, and any category related policies
    • Ensuring the projects agreed to within the Annual Category Plan are executed on a timely basis in line with the targeted goals and that the identified savings are delivered
    • Proactively identifying, reporting, and mitigating risks to delivery
    • Resolving issues and project risks on a timely basis to internal client satisfaction and escalating issues and risks where appropriate
    • Liaising with Procurement Leads to request in country intelligence or other required support as required
    • Ensuring a smooth and efficient handover Global / Regional category teams, regional / site teams, and the Operational Buying Unit


    Required Experience:

    • Degree level educated, with business or life sciences degree preferable
    • 3+ years Procurement or Supply Chain experience delivering measurable value in strategic sourcing, enterprise cost reduction, and / or operational efficiency projects
    • Demonstrated understanding of some / all major indirect spend categories, potential cost levers or market fundamentals. Previous Manufacturing or R&D sourcing expertise would be highly advatageous.
    • 3+ years of Project Management experience including risk management, project reporting, and delivering quantitative and qualitative results in complex and pressured environments
    • Demonstrated success in managing projects to deliver against set targets
    • Demonstrated experience in delivering results and managing projects across markets
    • Strong experience in upwards communication and senior stakeholder management
    • Good facilitation and upwards management skills supported by good interpersonal competencies (communication, influencing)
    • Proactive approach to problem solving
    • Proven capability in negotiation, conflict resolution and stakeholder management
    • Expert proficiency in basic MS Office software.
    • Knowledgeable in Procurement specific systems and processes for the efficient management of sourcing events and contract negotiations (e.g. eSourcing, eAuction) with familiarity and awareness of relevant legal risks and issues
  • Data Management

    Competitive
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    Join an established global Medical Device company based in Greater London, who are currently looking for a Service Now Consultant with Project Managment experience. This company is looking for talented Service Now implementation skills with strong team leadership capabilities to join their ever expanding Software and IT teams.

    This highly reputable company with increasing market presence in innovation within Life Sciences across the UK and Globally. They are offering a 3 month contract with potential to extend.

    The ideal candidate for this role should have strong knowledge of ServiceNow Deployment, with PMI or Prince Certificate in project management and/ or experience project managing SaaS and PaaS solutions. Knowledge of HR/Shared Service for HR Case managment modules for medium – large sized corporations would be an asset.

    Strong understanding of using ServiceNow delivery and design strategy through documentation with experience in anaysing business requirements and translating those requirements to application development teams.

    Equally they are keen to engage with candidates who have proven success on projects with large-scale deployments and understanding of application life-cycle management.

    This oppertunity will provide experience with a global company, with excellent potential to grow your project portfolio in both management abilities and hands on technical deployment across multi-teir complex systems globally.

    If you are interested in this role reach out to:
    amy.mchugh@skillsalliance.com

  • Clinical Operations

    £50 - £80 per hour
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    The Global Clinical Sciences and Operations department, are looking for an individual to fill the position of Senior Clinical Project Manager.

    Start date:as soon as possible
    Duration: 12 months –

    JOB SUMMARY
    Accountable for the delivery of one or more studies from protocol through to study report and archiving. These can be all types of study from First in Human to Phase IV Accountable for managing the interface between the company, Phase 1 Units, CROs and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, on time and on budget.

    Accountable for leading the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads.

    The level of CPM assigned to a project (either CPM or Senior CPM) will be dependent on study complexity and type (e.g. First in Human studies), scope, size and geography.

    Senior CPMs will be accountable for more complex studies and/or those with high visibility such as pivotal trials or challenging POC studies.


    MAJOR ACCOUNTABILITIES
    • Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the internal and CRO/Phase 1 Unit teams.

    • If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework depending on the specialist need of the study.

    • At the study kick-off meeting, articulate study scope, goals, and expectations of Sponsor to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.

    • Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR.

    • Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.

    • Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.

    • Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.

    • Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.

    • Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders.

    • Become familiar with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.

    • Understand, manage, track and ensure accuracy of study budgets in systems, including the forecast and accrual information.

    • For assigned studies, work closely with the respective Program Delivery Leads, and other team members and stakeholders as required, to serve as the key internal clinical operations contact whilst keeping the PDL updated on all study issues.

    • Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs/Phase 1 Units and other vendors.

    • Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols, protocol amendments, and other relevant study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.

    • Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate).

    • Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs).

    • Support Data cleaning and data evaluation meetings (DEM) and Results Interpretation Meetings (RIMs) • Support conduct of Data Monitoring Committee (DMC)/Safety Monitoring Committee (SMC) review meetings.

    • Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.

    • Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members.

    • Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices.

    • Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.

    • Asia Specific – support any Regulatory Authority consultation activities.sm

    • Provide study specific training for internal (i.e. Sponsor) and external (i.e. CRO, vendors, investigators) team members.

    • Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.

    • Visit investigational sites and Phase 1 Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies.

    • Travel including overnight stays- possibly global – required.

    • A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience as appropriate.

    • A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel.

    • Perform other tasks as deemed necessary by the Company.

    EDUCATION & QUALIFICATION
    Minimum BA/BSc

    At least three years’ relevant experience in clinical development including team leadership.

    Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion.

    *A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.*

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Apply

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    Job Overview
    The Senior Analyst, PV Vendor & Alliance Management (PVAM) is responsible for supporting the activities performed within this group. This position assists the leaders of PV Vendor & Alliance Management in the effective oversight of outsourced activities, monitoring service provider performance and compliance with their contractual obligations. This position will interact with PV staff, staff in other departments and with
    service providers performing activities supporting the global PV system.

    Essential Functions

    • Acts as an external training coordinator and coordinates Adverse Event reporting training to service providers supporting programs
    • Coordinates PV review of project materials for programs which have the potential to generate safety information
    • Coordinates implementation of Safety Reporting plans for programs with the potential to generate safety information
    • Maintains a tracker of all programs for which the PV review of materials has been coordinated.
    • Coordinates access (on-boarding / off-boarding) to network and the global safety database for service provider staff, as appropriate.
    • Monitors the PVAM mailbox and responds to queries.
    • May assist with update to Service Provider Oversight Plans.
    • May assist with update to PVAM controlled documents.
    • Supports collection of information required to update designated sections of the PSMF.
    • Facilitates service provider on-boarding and ongoing training for products, data bases and SOPs and ensures service providers have access to all current reference materials appropriate to their remit.
    • Coordinates PVAM departmental meetings and is responsible for maintenance of the PVAM tracker
    • Undertakes additional projects, as assigned, in support of PV or other business goals.

    Required Knowledge, Skills, and Abilities

    • Knowledge of and experience with EU and US FDA PV regulations
    • In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area
    • Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
    • Experience interacting with service providers or external business partners
    • Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships
    • Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence
    • Ability to work effectively within a matrix organization to achieve desired outcomes
    • Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives
    • Ability to work across cultures, including in a virtual environment
    • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
    • Proven ability to demonstrate values

    Required/Preferred Education and Licenses

    • Health Care Professional Degree or Life Science Degree, or equivalent experience required
    • A minimum of 3 years’ experience in pharmaceutical safety required
    • Experience in a role involving vendor partnership/relationship management responsibilities preferred
  • Clinical Operations

    £60000 - £80000 per annum, bonus + shares + benefits
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    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-80K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £80000 per annum, bonus + shares + benefits
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    Share

    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-80K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Regulatory

    £50 - £80 per hour
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    This is a 12 Month remote contract position working with a leading CRO based in London. They are seeking Regulatory Affairs Subject Matter Expert to serve as a periodic advisor to select Sponsors at our client. This person could be assigned to projects for their duration or may be called upon to answer ad-hoc questions as required.

    In terms of the performance and personal competencies required for the position, we would highlight the following:

    • Prefer advanced degree, such as PhD or MD with minimum 15 years combined experience in Global Regulatory Affairs and Clinical Development, in at least two therapeutic areas across phase I-IV; has a track record of successful filings.
    • An experienced leader who has successfully managed high performance cross-functional teams, worked in a matrix structure, with the ability to translate strategy into clear operational objectives.
    • Have the gravitas, confidence and executive presence to operate with business leaders. Be self-confident, but without ego. Have not only scientific credibility, but obvious business acumen.
    • Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, EU, Japan).
    • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
    • Demonstrated ability to coordinate global activities and has a track record in regulatory success is important.
    • Excellent verbal and written communication skills and collaborative interpersonal skills.
  • Procurement

    $200000 - $260000 per annum
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    Skills Alliance are partnering one of the most exciting, fastest growing biotechnology start-up organizations in the US. After gaining significant investment, they are expanding operations in Massachusetts to include a new strategic procurement and supply chain management team.

    As part of this new greenfield transformation, they are seeking to recruit an experienced Procurement Lead to drive forward category strategies, sourcing projects and building stakeholder relations across their laboratory operation. You will be responsible for the Lab Services, Supplies and Equipment spend in what will be a very expansive and science-driven environment. We are considering candidates for this position at either Director, or Senior Director level within the organization (dependent on experience).

    Responsibilities:

    • Build the Lab Consumables, Equipment, and Services category/team from the ground up, ensuring that key products and services are available at the highest level of quality, efficiency, and cost.
    • Develop overall category vision, strategy, priorities, and portfolio of projects, collaborating with relevant business stakeholders to ensure effective alignment.
    • Design and implement an effective strategy for lab consumables, equipment, and service-related spend areas, collaborating with cross-functional teams to gather business requirements and market insights that support key decisions.
    • Assess options and strategies for supply chain and sourcing, and oversee plans for implementation and operationalization.
    • Develop a robust portfolio of sourcing projects to achieve year-over-year productivity and deliver cost savings targets.
    • Ensure relevant customer-centric procurement KPIs are created, implemented, and tracked.
    • Initiate, negotiate, and execute contracts and agreements for commercial terms, intellectual property, and confidentiality, working with our Legal Team to ensure compliance with all legal, ethical, and procurement standards.
    • Develop and manage key supplier relationships through appropriate programs (e.g. alliance/supplier relationship management) to enable innovation and cost reduction through mutual accountability and trust.
    • Establish category and supplier management processes, driving the value messaging of and compliance with these processes across the company
    • Support the Lab Consumables, Equipment, and Services Team by securing the appropriate sponsorship, resources, and implementation support, and providing strategic insight and access to all relevant resources and data.
    • Ensure that the team engages with and fully supports supply base and supplier management strategies, helping to identify and resolve compliance issues with respect to the usage of preferred suppliers.
    • Help to meet deliverables, as agreed upon during Category Plan development

    Required Experience:

    • Bachelor’s or Master’s degree in supply chain management, procurement operations, or related field
    • 10+ years of experience with sourcing laboratory equipment; prior experience with SME pharma/biotech companies strongly preferred
    • Prior management experience with lab consumables, equipment, and service category/spend – as well as direct management of team members – preferably within a laboratory and/or scientific environment
    • Strong leadership skills, with the ability to establish and execute new strategies and processes
    • Proven ability to manage negotiations, suppliers, and contracts
    • High-level problem-solving and analytical skills, with the ability to identify, maintain, and utilize key metrics to make data-driven decisions and make continuous improvements
    • Exceptional ability to build strong relationships, develop negotiation strategies, and influence technical, business, and operational decisions
    • Strong multitasking skills, with the ability to work on multiple, concurrent projects and adapt to changing priorities in a fast-paced, high-growth environment
    • Excellent verbal/written communication skills and attention to detail, with the ability to efficiently organize information, analyze large datasets, and present data in a clear and impactful manner
  • Procurement

    $140000 - $180000 per annum
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    Skills Alliance are partnering one of the most exciting, fastest growing biotechnology start-up organizations in the US. After gaining significant investment, they are expanding operations in Massachusetts to include a new strategic procurement and supply chain management team.

    As part of this new greenfield transformation, they are seeking to recruit an experienced Procurement Manager to drive forward category strategies, sourcing projects and building stakeholder relations across their laboratory operation. You will be responsible for the Lab Services, Supplies and Equipment spend in what will be a very expansive and science-driven environment. We are considering candidates for this position at Manager to Associate Director level (dependent on experience).


    Responsibilities:

    • Manage the continuous sourcing of lab equipment and services, ensuring uninterrupted supply.
    • Create and execute effective strategies for lab equipment and services-related spend areas, collaborating with cross-functional teams and relevant stakeholders to gather business requirements and market insights to drive decisions.
    • Collaborate with stakeholders to consolidate volumes and assist with instrumentation maintenance coverage selection.
    • Assess options and strategies for supply chain and sourcing, and oversee plans for implementation and operationalization.
    • Support Buy versus Lease decisions.
    • Initiate, negotiate, and execute contracts and agreements for commercial terms, intellectual property, and confidentiality, working with our Legal Team to ensure compliance with all legal, ethical, and procurement standards.
    • Build effective spend management tools to drive effective decisions regarding the total cost of ownership and asset utilization.
    • Develop and manage key supplier relationships through appropriate programs.
    • Collaborate with finance to streamline the budget/forecasting process relating to third-party spend.


    Required Experience:

    • Bachelor’s or Master’s degree in supply chain management, laboratory technology, or related field.
    • 5+ years of experience with sourcing laboratory equipment; prior experience with SME pharma/biotech companies strongly preferred.
    • 3+ years of experience with managing lab equipment and service category/spend, preferably within a laboratory and/or scientific environment.
    • Proven ability to manage negotiations, suppliers, and contracts.
    • Strong analytical, strategic, and critical thinking skills.
    • Excellent verbal/written communication skills and attention to detail, with the ability to efficiently organize information, analyze large datasets, and present data in a clear and impactful manner.
    • High-level ability to build strong relationships and influence technical, business, and operational decisions.
    • Strong multitasking skills, with the ability to work on multiple, concurrent projects and adapt to changing priorities in a fast-paced, high-growth environment.
  • Clinical Operations

    £60000 - £75000 per annum, Bonus + benefits
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    Share

    Great opportunity for an experienced Clinical Project Manager or Study Manager to join a niche Bitoech working in Oncology. The role would be home-based initially with some travel to the office when normality resumes.

    The role is with a niche company who are very innovative and work specifically in Oncology. The company is growing quickly and have exciting early phase programs ongoing. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence and Oncology trial management is essential for this role.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the London office further down the line. They offer an excellent salary in the region of £60-75K depending on expeirence + bonus + benefits.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £60000 - £80000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    *PHARMA EXPERIENCE REQUIRED*

    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The (Senior) R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London with some flexibility. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Share

    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have had excellent results from early phase trials. The company is growing quickly and have advanced therapies trials that are progressing well. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the office in the London area when they can return to the office. They offer an excellent salary – circa £50-60K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £85000 per annum, Bonus + benefits
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    Share

    Great opportunity for an experienced Clinical Project Manager or Study Manager to join a niche Bitoech working in Oncology. The role would be home-based initially with some travel to the office when normality resumes.

    The role is with a niche company who are very innovative and work specifically in Oncology. The company is growing quickly and have exciting early phase programs ongoing. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence and Oncology trial management is essential for this role.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the London office further down the line. They offer an excellent salary in the region of £60-85K depending on expeirence + bonus + benefits.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    Share

    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-90K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £50000 - £60000 per annum, excellent package
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    Share

    A rare opportunity to join a fast growing Advanced Therapies focused Biotech. This is a permanent Clinical Trial Manager or Clinical Study Manager role based in the London area.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for an experienced Junior Study Manager or Clinical Trial Manager, this would be working on interesting studies from phase I-III. They require a clinical trial management experience, ideally experience in early phase, complex TAs and experience of working with sites. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London area with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 50-60K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, Excellent package
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    Share

    *PHARMA EXPERIENCE REQUIRED*

    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The (Senior) R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London with some flexibility. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
    Apply

    Job
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    Share

    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Manufacturing

    Competitive
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    Share

    Pour le compte d’une société biopharmaceutique avec un site de production dans le canton de Neuchâtel, Skills Alliance est à la recherche d’un QA Expert (CDI) qui sera responsable de l’Assurance Qualité tout au long des processus de production et de libération des lots.

    Responsabilités:

    • Participer aux activités quotidiennes liées à la revue des dossiers de lot et des données associées pour la libération des lots;
    • “Change control” selon les procédures, méthodes, systèmes qualité et des dossiers règlementaires applicables;
    • Maintenir le ”mapping” organisé des variants de procédés (les codes produits);
    • Résolution des problèmes et des causes à l’origine des déviations et CAPA;
    • Audits GMP internes;
    • Implémentation des projets du site en accord avec les exigences réglementaires et du département Qualité.

    Profil recherché:

    • Diplôme en Ingénierie, Biotechnologie, Pharmacie ou Qualité;
    • 3 années d’expérience en Assurance Qualité / Contrôle Qualité;
    • Connaissance des réglementations FDA, EMA, ICH, Pharmacopées;
    • Connaissance des normes système qualité;
    • Maitrise du français et niveau d’anglais professionnel (B2).

    Pour recevoir plus d’informations sur ce poste, veuillez postuler ou contacter Khephren Mongongu au +41 43 508 29 16.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Share

    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    I am partnered with an exciting Pharma client in the London area to help build out a new team in Oncology.

    This Pharma works across a range of areas but is investing a lot in Oncology at present. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market, rate of growth and the new team, this is a rare and exciting proposition. This is working in their Oncology business unit.

    They are recruiting for a Senior Clinical Study Manager to join the team and need a very experienced and accomplished Oncology Project/Study Manager.. Pharma/Biotech experience is preferred and significant Oncology experience is required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £65-75K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-90K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £90000 per annum, Bonus + benefits
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Great opportunity for an experienced Clinical Project Manager or Study Manager to join a niche Bitoech working in Oncology. The role would be home-based initially with some travel to the office when normality resumes.

    The role is with a niche company who are very innovative and work specifically in Oncology. The company is growing quickly and have exciting early phase programs ongoing. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence and Oncology trial management is essential for this role.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the London office further down the line. They offer an excellent salary in the region of £65-85K depending on expeirence + bonus + benefits.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, excellent package
    Apply

    Job
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    Share

    A rare opportunity to join a fast growing Advanced Therapies focused Biotech. This is a permanent Clinical Trial Manager or Clinical Study Manager role based in the London area.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for an experienced Junior Study Manager or Clinical Trial Manager, this would be working on interesting studies from phase I-III. They require a clinical trial management experience, ideally experience in early phase, complex TAs and experience of working with sites. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London area with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 50-60K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have had excellent results from early phase trials. The company is growing quickly and have advanced therapies trials that are progressing well. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the office in the London area when they can return to the office. They offer an excellent salary – circa £50-60K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Apply

    Job
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    Share

    I am actively recruiting on behalf of a dynamic pharmaceutical company who are launching a COVID-19 Study at with intention to start by the end of Feb.

    The role will be EDC focused and will play a vital role in the supporting the clinical team as they run the remote trial. You will not be in direct contact with the patients and the calls are done remotely, they would like individuals to be open to traveling to sites (Located around the city) should COVID-19 permit at a later date but are set up to work remotely.

    800 patient study with a projected 200 patient calls a month across the team, with 3 individuals looking to be on-boarded in this time I would like talk through the role in more depth and introduce the company.

    They are paying a competitive market rate, if interested please do apply and we can book a call to disscuss this futher.

    This role does not offer sponsorship

  • Data Management

    €35000 - €40000 per annum
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    Share

    Skills Alliance recrute pour le compte de son client une biotech specialisee dans l Equipment des laboratoires un It Administrateur Systemes et reseaux

    Ceci est un contrat de 6 mois avec une possibilite de Cdi par la suite

    En tant qu administrateur vous prenez en charge les activites liees au fonctionnement et a la maintenance du reseau local de la societe de linfrastructure migration Cloud en Azur et participez a la gestion de reseau etendu de l ensemble des entites du groupe

    Vous etes responsable egalement de l installation et la maintenance du materiel informatique des appareils mobiles et des logiciels pour permettre aux utilisateurs d acceder au reseau

    Missions

    Assurer l assistance technique de premier niveau pour les questions liees aux PC materiel logiciels telecommunications et imprimantes

    Gerer Windows active directory

    Installer configurer et maintenir les serveurs et postes de travail du reseau local

    Tester et evaluer le materiel et les logiciels

    Si vous etes titulaire d un bac plus 5 en informatique et que vous disposez deja d une experience dans un environnement Windows Microsoft server switches routers firewalls TCP IP DNS Microsoft Active Directory VMWare VSphere Office 365 One Drive SharePoint Microsoft Azure ideellement 4 ans je serai ravie de recevoir votre candidature
    L utilisation de l anglais est obligatoire pour ce poste ecrit et oral

    Localisation

    Poste Base a Moirans enMontagne avec des deplacements reguliers au sein de la societe mere basee a Villiers le Bel

  • Clinical Operations

    £85000 - £95000 per annum, Bonus + benefits
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    Share

    Skills Alliance are partnered with a very exciting and growing Biotech at present to hire for an Associate Director, Clinical Operations role in London.

    The organisation are going through a period of growth due to their own ongoing trials and a partnership with a leading global Pharma. They work in complex trials across phases I-III and work in areas of unmet medical need to hopefully have a big impact on patients’ lives. We have placed numerous people in their clin ops in the past three years and have had great feedback. They are UK based but with a global footprint.

    ASSOCIATE DIRECTOR, CLINICAL OPERATIONS – circa £85-95K

    Senior role reporting to the Global Head of Clin Ops. Line management of a group of 10-12 clin ops staff and operational responsibility including strategy, also program oversight. Strong stakeholder management required and experience in Biotech/Pharma. Significant line management experience of clin ops teams required.

    This is a permanent and full-time role, based in Central London. They will offer an excellent salary and package.

    Please get in touch with Mark Anderson for more info – 0207 220 6209 or Apply now.

  • Clinical Operations

    £75000 - £85000 per annum, Bonus + benefits
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    Skills Alliance are partnered with a very exciting and growing Biotech at present to hire for a Clinical Program Manager role in London.

    The organisation are going through a period of growth due to their own ongoing trials and a partnership with a leading global Pharma. They work in complex trials across phases I-III and work in areas of unmet medical need to hopefully have a big impact on patients’ lives. We have placed numerous people in their clin ops in the past three years and have had great feedback. They are UK based but with a global footprint.

    CLINICAL PROGRAM MANAGER – circa £75-85K

    Oversight of a portfolio of complex studies, potentially around 6 or 7 in total in phases I, II and III. No line management, purely program management. Overall budget responsibility. Experience of managing complex studies/programs required and previous program management required.

    This is a permanent and full-time role, based in Central London. They will offer an excellent salary and package.

    Please get in touch with Mark Anderson for more info – 0207 220 6209 or Apply now.

  • Project Management

    £60000 - £75000 per annum, Bonus + benefits
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    Skills Alliance are partnered with a very exciting and growing Biotech at present to hire for an Senior Project Manager (cross-functional) role in London.

    The organisation are going through a period of growth due to their own ongoing trials and a partnership with a leading global Pharma. They work in complex trials across phases I-III and work in areas of unmet medical need to hopefully have a big impact on patients’ lives. We have placed numerous people in their clin ops in the past three years and have had great feedback. They are UK based but with a global footprint.

    SENIOR PROJECT MANAGER – circa 60-75K

    Cross-functional PM for one or two complex trials, with study managers reporting into this position. Matrix management, oversight of budgets and timelines for projects. Previous cross-functional experience required from Biopharma or CRO and working with complex therapy areas.

    This is a permanent and full-time role, based in Central London. They will offer an excellent salary and package.

    Please get in touch with Mark Anderson for more info – 0207 220 6209 or Apply now.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help build out a new team in Oncology.

    This Pharma works across a range of areas but is investing a lot in Oncology at present. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market, rate of growth and the new team, this is a rare and exciting proposition. This is working in their Oncology business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Oncology Project/Study Manager.. Pharma/Biotech experience is preferred but they will consider people from CRO and significant Oncology experience is required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This Pharma works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager.. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Commercial

    Competitive Pay + Commission Structure
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    We are currently partnered with a groundbreaking digital pathology company that is building software to accelerate pathology’s transition from microscope to images, and effectively change the way we think about cancer altogether. Our client’s proprietary software has been developed by pathologists, for pathologists, ensuring that the scientists on the front lines are getting a product that was designed from the ground up to best support their workflows.

    After a couple of successful funding rounds, they are looking to grow their commercial sales team. This opportunity in particular is for the Head of Sales for their American business. In this role, you are responsible for the commercial success in the United States. Our client is known for pushing the limits of medicine and technology, solving problems the world has never solved before, but they can’t solve medicine alone. That’s why they’re looking for curious thinkers. Big dreamers. Developers, evangelists, pathologists, and scientists. Exceptional talent to help them use great power for good and advance humankind.

    Responsibilities:

    • Develop a Regional Sales Strategy to achieve or exceed goals, metrics, and expectations.
    • Develop strong knowledge of market, accounts, and competition and industry trends in the region.
    • Communicate overall strategy with all stakeholders including service. Adapt new GTM strategies to align with evolving customer needs.
    • Monitor, analyze, and drive sales metrics and results. Manage and drive funnel growth and forecast accuracy.
    • Coach Sales Managers in executing their business and hold them accountable for their results. Develop and leverage relationships to assist the sales team in deal closure.
    • Create and sustain relationships with senior players and CxOs at major accounts.
    • Coach the Sales Managers to meet and manage customer expectations throughout the sales process. Ensure customer issues are resolved through the escalation process.
    • Coordinate execution with key internal stakeholders to support the prospect/ customer’s needs throughout the sales process.
    • Develop and practice effective coaching skills to create a high performing team. Ensure the usage of standard processes and guidelines by the team.
    • Coach Sales Managers to create winning account and deal strategies with a unified approach to the customer.
    • Build a strong regional team through hiring, succession planning, and onboarding. Set clear expectations and communicate regularly to promote understanding. Foster a culture of teamwork, transparency, and performance-oriented growth.

    Qualifications:

    • 10+ years of enterprise software sales leadership into the clinical and/ or life sciences industry. Preferably in Healthcare informatics (PACS) or in Digital Pathology.
    • Consistent and successful sales track record (i.e. over-quota performance, forecast accuracy, balanced portfolio, notable competitive wins, etc.)
    • Demonstrates superior industry knowledge on market trends, products, and competitors in the healthcare informatics/digital pathology space.
    • Executive level selling, negotiation, and facilitation skills.
    • Leadership and team building skills.
    • Degree level education or equivalent.
    • Willing to undertake significant travel.
    • Strong moral compass.

    We are trying to move quickly on this role, so please be sure to apply today! Feel free to reach out to Ryan, the account executive for this position, directly at ryan.barrett@skillsalliance.com with any questions.

  • Commercial

    Competitive Pay + Commission Structure
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    Location: Philadelphia, PA

    We are currently partnered with a groundbreaking digital pathology company that is building software to accelerate pathology’s transition from microscope to images, and effectively change the way we think about cancer altogether. Our client’s proprietary software has been developed by pathologists, for pathologists, ensuring that the scientists on the front lines are getting a product that was designed from the ground up to best support their workflows.

    After a couple of successful funding rounds, they are looking to grow their commercial sales team. This opportunity in particular is for a Sales Director for their Life Sciences business. In this role, you are responsible for the commercial success of their Pharma, CRO, and Biotech segments on the East Coast. Our client is known for pushing the limits of medicine and technology, solving problems the world has never solved before, but they can’t solve medicine alone. That’s why they’re looking for curious thinkers. Big dreamers. Developers, evangelists, pathologists, and scientists. Exceptional talent to help them use great power for good and advance humankind.

    Responsibilities:

    • Lead sales to the life sciences segments (Pharma, CROs and biotech companies) in the East Coast of US.
    • Develop and execute a successful sales strategy for rapid revenue growth and market share expansion in the assigned territories. Contribute to business growth by meeting or exceeding bookings/ orders expectations.
    • Initialize and coordinate all efforts to strategic accounts (including tender participation) to maximize the opportunity for the sale of Proscia’s life sciences portfolio.
    • Develop, maintain, and improve relations with accounts to keep or to set Proscia as the preferred supplier. Ensure continuity of the relationship and operate at the highest level in the accounts’ organizations, facilitating the executive level interfaces.
    • Accurately complete and maintain sales forecast, customer data and other records in an orderly and timely fashion (SFDC).
    • Provide active inputs into local marketing strategies.
    • Participate in monitoring and reporting on the activities of competitors, potential collaborators, as well as identifying business opportunities.

    Qualifications:

    • Bachelor’s degree with 10+ years – OR – Master’s degree with 8+ years of proven experience in software solution/ informatics sales to Life Sciences Organizations.
    • Requires extensive knowledge and experience in digital pathology, image analysis, and AI solutions.
    • Proven ability to target key accounts and management in the territory and identify market potential.
    • Ability to perform against established performance goals and metrics
    • Willingness to independently work in a non-hierarchical company
    • Ability and curiosity to learn
    • Fluent in English, verbal and written.
    • Willing to undertake significant travel.

    We are trying to move quickly on this role, so please be sure to apply today! Feel free to reach out to Ryan, the account executive for this position, directly at ryan.barrett@skillsalliance.com with any questions.

  • Commercial

    Competitive Pay + Commission Structure
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    We are currently partnered with a groundbreaking digital pathology company that is building software to accelerate pathology’s transition from microscope to images, and effectively change the way we think about cancer altogether. Our client’s proprietary software has been developed by pathologists, for pathologists, ensuring that the scientists on the front lines are getting a product that was designed from the ground up to best support their workflows.

    After a couple of successful funding rounds, they are looking to grow their commercial sales team. This opportunity in particular is for a Sales Director for their Clinical business. In this role, you are responsible for the commercial success of their Health System, Commercial Lab, and Academic Medical Center segments on the East Coast. Our client is known for pushing the limits of medicine and technology, solving problems the world has never solved before, but they can’t solve medicine alone. That’s why they’re looking for curious thinkers. Big dreamers. Developers, evangelists, pathologists, and scientists. Exceptional talent to help them use great power for good and advance humankind.

    Responsibilities:

    • Responsible for sale to the clinical segments (Commercial labs, Health Systems and Academic Medical Centers) in the East of US.
    • Develop and execute a successful sales strategy for rapid revenue growth and market share expansion in the assigned territories. Contribute to business growth by meeting or exceeding bookings/ orders expectations.
    • Initialize and coordinate all efforts to strategic accounts (including tender participation) to maximize the opportunity for the sale of Proscia’s clinical portfolio.
    • Develop, maintain, and improve relations with accounts to keep or to set Proscia as the preferred supplier. Ensure continuity of the relationship and operate at the highest level in the accounts’ organizations, facilitating the executive level interfaces.
    • Accurately complete and maintain sales forecast, customer data and other records in an orderly and timely fashion (SFDC).
    • Provide active inputs into local marketing strategies.
    • Participate in monitoring and reporting on the activities of competitors, potential collaborators, as well as identifying business opportunities.

    Qualifications:

    • At the minimum, 10 years of healthcare sales experience and 5+ years of proven experience in healthcare informatics, medical device sales with specific experience at hospital CEO/ management level.
    • Requires extensive knowledge and experience in Healthcare Informatics, preferably, digital pathology.
    • Proven ability to target key accounts and management in the territory and identify market potential.
    • Ability to perform against established performance goals and metrics.
    • Willingness to independently work in a non-hierarchical company.
    • Ability and curiosity to learn.
    • Fluent in English, verbal and written.
    • Willing to undertake significant travel.

    We are trying to move quickly on this role, so please be sure to apply today! Feel free to reach out to Ryan, the account executive for this position, directly at ryan.barrett@skillsalliance.com with any questions.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    I am partnered with an exciting Pharma client in the London area to help build out a new team in Oncology.

    This Pharma works across a range of areas but is investing a lot in Oncology at present. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market, rate of growth and the new team, this is a rare and exciting proposition. This is working in their Oncology business unit.

    They are recruiting for a Senior Clinical Study Manager to join the team and need a very experienced and accomplished Oncology Project/Study Manager.. Pharma/Biotech experience is preferred and significant Oncology experience is required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £65-75K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Supply Chain

    £400 - £500 per day
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    Skills Alliance are supporting a global pharmaceutical organisation, undertaking a significant SAP S/4 HANA migration and process tranformation. As part of this programme, they are seeking a SAP Business Systems Analyst with a strong track record across SCM modules, to support the Supply Chain Stream as part of a program of implementations.

    Note: This will be an 11-month initial contract and sits inside IR35.

    Key Responsibilities:

    • Providing SAP expert knowledge in the functional area of Supply Chain Management in response to business requirements and to co-ordinate solutions in conjunction with our IT Technical partners.
    • Provide Business Process expertise in logically analysing and documenting Business Scenarios in collaboration with a large number of stakeholders across the Business and IT.
    • Key driver of technical change between the Business and IT – drive User Requirements/Design sessions and help co-ordinate subsequent User Testing phases and implementation.
    • Act as a bridge between the Business community and the various workstreams within a highly regulated environment.
    • Coordinate the testing activities necessary to ensure the smooth deployment of the system.
    • Support the preparation for operational readiness and work with the EMEA SCM team (affiliates, central teams and internal Manufacturing Plants) to coordinate these activities.
    • Support the affiliates and the Enterprise Master Data team in data preparation and load.
    • Support the cutover of activities for go live.
    • Support Post go live activities.


    Required Experience:

    • 5+ years SAP Supply Chain experience preferably in a regulated private-sector industry (pharmaceuticals, financial services, oil & gas).
    • Experience in SAP deployment life cycle – design, configuration, test, data conversion.
    • Experience working on large scale SAP landscapes.
    • A background helping to manage offshore partners, ensuring they deliver in terms of quality and on time.
    • Understanding of global templates across multiple countries
    • A flair for systems and willingness to learn new systems quickly as a self-starter
    • Willingness to travel on occasion when international conditions next permit.

    Required Qualifications:

    • Formal SAP and SAP SCM certifications highly desirable
    • Eligible to work in the UK as a contractor
    • Initially the role will be 100% remote, however some travel to the office in Surrey may be required after Covid restrictions lift.
  • Tech Ops

    €80 - €95 per hour
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    Great opportunity for a Process Engineer to join a leading Pharmaceutical company in Switzerland on a contract basis. This would initially be for 6 months, with likely extensions at the end of that period.

    This opportunity is within the Process Engineering team, focusing on the process planning and design of Upstream and Downstream equipment in a biopharmaceutical plant setting. As the project develops, you will be responsible for the conception, planning, construction supervision, commissioning, and qualification to handover to the customer.

    Key requirements for the role include:

    • Prior experience within a Biopharmaceutical / Biotech environment
    • Experience with Upstream and/or downstream process equipment
    • Process design experience, including P&ID’s, Process flow diagrams (PFD’s)
    • Experience working within GMP environment.

    If you would like to learn more, please apply now or reach out to Josh Taylor at Skills Alliance

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £300 - £350 per week
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    Company Overview:
    The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of products. For the team based in our International Headquarters in West London, we are looking for a Clinical Trial Manager Associate to work within the Oncology therapy area.

    Essential Duties and Job Functions:
    • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
    • Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
    • Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
    • Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
    • Review of trip reports generated by CRO CRAs
    • Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
    • Assists with the preparation and organization of international investigator meetings. Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
    • Performs administrative duties in a timely manner as assigned.
    • Travel is required up to 20-30%. (Role is currently remote due to COVID-19)

    Experience, knowledge and skills:
    • Typically requires a BS or BA in a relevant scientific discipline
    • Minimum 2 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
    • CRA experience preferred.
    • Oncology experience preferred but not essential.
    • Excellent verbal, written, interpersonal and presentation skills are required.
    • Must be familiar with routine medical/scientific terminology.
    • Must be familiar with Word, PowerPoint, and Excel.
    • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
    • Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.

    (All applicants must be happy to work through an Umbrella/PAYE as the contract will be inside IR35)

  • Clinical Operations

    €90 - €160 per hour
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    Company overview
    Commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Their commercialized product is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. In addition this company has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications – non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.

    As the result of the launch of multiple phase II and III clinical trials we are looking for professionals who would be excited to join a fast-growing, international Clinical Operations team at our Swiss HQ.

    Senior Clinical Trial Manager
    You will be responsible for providing strategic leadership and oversight of clinical trials conducted in Europe (and other regions as needed) to ensure completion on time, within budget and of high quality in compliance with all applicable regulations, guidelines and Standard Operating Procedures. You must have a very good understanding of the project status, be able to proactively identify risks and address them appropriately (including escalation to senior management).

    Responsibilities
    The CTM responsibilities include, but are not limited to the following:
    Drive execution of the assigned clinical trial(s) on a regional level according to agreed timelines, scope and budget which includes:

    • site identification and selection
    • coordination of submissions to Competent Authorities
    • oversight of the enrollment activities on a global, country and site level
    • ensuring timely data collection, cleaning and lock
    • oversight of the clinical monitoring activities
    • oversight of CROs and other vendors

    Focus on quality

    • ensure that clinical trials are conducted in accordance with applicable regulations, ICH GCP, FDA CFR and internal Standard Operating Procedures
    • lead the preparation and follow-up after site, vendor or sponsor audits and inspections
    • be able to work with moderate supervision
    • develop and negotiate site budgets
    • prepare study reports and ensure required tools and tracking databases are kept up to date as required
    • ensure activities comply with the applicable Quality System requirements.
    • other responsibilities as assigned

    Qualifications

    • Bachelor’s degree in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school
    • Minimum of 10 years’ experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
    • Accredited GCP course desirable

    Knowledge/Skills

    • Fluency in English (verbal and written) and excellent communication skills
    • Strong critical thinking and problem solving skills
    • Ability to work well in a team environment
    • Strong critical thinking and problem solving skills
    • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
    • Excellent organizational and record-keeping skills
    • Ability to maintain excellent working relationships with a broad range of trial staff
    • Flexibility in work hours and readiness to travel abroad on a routine basis
    • Advanced computer literacy

    Happy to have remote applicants across the EMEA, with a preferance of being Swiss based, This assignment will but up to 1 FTE looking for applicants ASAP.

  • Clinical Operations

    £50000 - £60000 per annum, excellent package
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    A rare opportunity to join a fast growing Advanced Therapies focused Biotech. This is a permanent Clinical Trial Manager or Clinical Study Manager role based in the London area.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for an experienced Junior Study Manager or Clinical Trial Manager, this would be working on interesting studies from phase I-III. They require a clinical trial management experience, ideally experience in early phase, complex TAs and experience of working with sites. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London area with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 50-60K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have had excellent results from early phase trials. The company is growing quickly and have advanced therapies trials that are progressing well. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the office in the London area when they can return to the office. They offer an excellent salary – circa £50-60K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-90K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £90000 per annum, Bonus + benefits
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    Great opportunity for an experienced Clinical Project Manager or Study Manager to join a niche Bitoech working in Oncology. The role would be home-based initially with some travel to the office when normality resumes.

    The role is with a niche company who are very innovative and work specifically in Oncology. The company is growing quickly and have exciting early phase programs ongoing. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence and Oncology trial management is essential for this role.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the London office further down the line. They offer an excellent salary in the region of £65-85K depending on expeirence + bonus + benefits.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Medical Devices

    COMPETITIVE
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    Skills Alliance are currently partnered with a leading European specialist pharmaceutical company who is also working on Medical Device products.

    They are looking for a QA Auditor (Medical Devices) for a stand alone position on a 12 month FTC with the potential to go permanent.

    This position can be fully remote with occasional travel for audits.

    (Knowledge and/ or experience of both ISO 13485 & EU Medical Device Requirements (MDD 93/42/EEC and MDR (EU) 2017/745) is mandatory.)

    Apply now for a confidential discussion to learn more.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for an experienced Clinical Study Manager or Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require a clinical trial management experience, ideally experience in early phase, complex TAs and interntional trial management expeirence. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Project Management

    £60000 - £70000 per annum, Bonus + benefits
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    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVD where other CROs haev struggled. They are a SME CRO who are dynamic and work in very interesting areas. Studies span phases I-IV and they work in interesting areas including Oncology and Gene Therapy.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has strong budget management expeirence. It could be working on a range of studies and would be working globally. There are also opporunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-70K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Project Management

    £60000 - £75000 per annum, Bonus + benefits
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    Skills Alliance are partnered with a very exciting and growing Biotech at present to hire for an Senior Project Manager (cross-functional) role in London.

    The organisation are going through a period of growth due to their own ongoing trials and a partnership with a leading global Pharma. They work in complex trials across phases I-III and work in areas of unmet medical need to hopefully have a big impact on patients’ lives. We have placed numerous people in their clin ops in the past three years and have had great feedback. They are UK based but with a global footprint.

    SENIOR PROJECT MANAGER – circa 60-75K

    Cross-functional PM for one or two complex trials, with study managers reporting into this position. Matrix management, oversight of budgets and timelines for projects. Previous cross-functional experience required from Biopharma or CRO and working with complex therapy areas.

    This is a permanent and full-time role, based in Central London. They will offer an excellent salary and package.

    Please get in touch with Mark Anderson for more info – 0207 220 6209 or Apply now.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This Pharma works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager.. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help build out a new team in Oncology.

    This Pharma works across a range of areas but is investing a lot in Oncology at present. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market, rate of growth and the new team, this is a rare and exciting proposition. This is working in their Oncology business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Oncology Project/Study Manager.. Pharma/Biotech experience is preferred but they will consider people from CRO and significant Oncology experience is required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    I am partnered with an exciting Pharma client in the London area to help build out a new team in Oncology.

    This Pharma works across a range of areas but is investing a lot in Oncology at present. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market, rate of growth and the new team, this is a rare and exciting proposition. This is working in their Oncology business unit.

    They are recruiting for a Senior Clinical Study Manager to join the team and need a very experienced and accomplished Oncology Project/Study Manager who would like to take on line management of a small team. Pharma/Biotech experience is preferred and significant Oncology experience is required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £65-75K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Project Management

    £60000 - £70000 per annum, Bonus + benefits
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    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has strong budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-70K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Project Management

    £60000 - £70000 per annum, Bonus + benefits
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    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies. *PHARMA EXPERIENCE REQUIRED*

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has strong budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-70K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Project Management

    £60000 - £65000 per annum, Bonus + benefits
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    Share

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies. *PHARMA EXPERIENCE REQUIRED*

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-65K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Data Management

    Competitive
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    6 Month Data Management Consultancy Role: Biotechnology

    Skills Alliance are working with an exciting Biotech based in the Nordics, on a Data Management role. The client is specialised within the Immuno-Oncology space, developing disruptive immune therapies for the treatment of cancer.

    Now entering phase 2&3 trials globally they are looking for a Data Manager who can work autonomously to collate information from their providers into one central system.

    This role will allow you to work within an agile biotech and be an integral part of business growth.

    To explore further, reach out to;
    amy.mchugh@skillsalliance.com

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, excellent package
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    A rare opportunity to join a fast growing Advanced Therapies focused Biotech. This is a permanent Clinical Trial Manager or Clinical Study Manager role based in the London area.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for an experienced Junior Study Manager or Clinical Trial Manager, this would be working on interesting studies from phase I-III. They require a clinical trial management experience, ideally experience in early phase, complex TAs and experience of working with sites. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London area with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 50-60K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-90K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £90000 per annum, Bonus + benefits
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    Great opportunity for an experienced Clinical Project Manager or Study Manager to join a niche Bitoech working in Oncology. The role would be home-based initially with some travel to the office when normality resumes.

    The role is with a niche company who are very innovative and work specifically in Oncology. The company is growing quickly and have exciting early phase programs ongoing. This would be working at the cutting edge of research with a great team who are looking to make a real impact on patients’ lives.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence and Oncology trial management is essential for this role.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the London office further down the line. They offer an excellent salary in the region of £65-85K depending on expeirence + bonus + benefits.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click “APPLY NOW”.

  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Clinical Operations

    €60 - €95 per hour
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    Seeking experienced CER writer to support a Dental implant device (Class IIb), to support a Dental Implants and CAD/CAM-based individualized prosthetics the key responsibilities are as followed:

    – Support in literature review and review of technical documentation
    – Support in leading project meeting related to clinical evaluation
    – Support in writing Clinical Evaluation Reports
    – Ad hoc Support for the line manager for clinical evaluation
    – Affected products: dental implants and their accessories & SaMD (latter is a wish)

    It is a 0.8 – 1 FTE contract starting in April or May and is fully remote, Is an English speaking role.

    The ideal candidates will have over 5 years CER experiance and have written Dental Implants CER. In the past.

  • Clinical Operations

    £60000 - £90000 per annum, bonus + shares + benefits
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    I am partnered with an exciting Oncology Biotech in Central London who have a unique model and a strong pipeline.

    This Biotech works specifically in Oncology and have a number of early phase assets, they work in a range of areas within the Oncology field. They have excellent funding and are a very secure organisation despite being relatively small. They plan to remain quite small and outsource the trials to CRO. They have a unique model and are doing exciting work in the cancer field.

    They are recruiting for a Senior Clinical Trial Manager to join the team and need a very experienced and accomplished Project/Study Manager, Ideally with several years working at senior trial management level. Pharma/Biotech experience, significant Oncology experience and early phase (I and II ideally) is required. You are likely to be responsible for several early phase projects. They need someone who autonomous and can work in a small and dynamic team. Protocol writing would be of benefits and experience of working cross-functionally.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in Central London. There is an excellent salary and package on offer – £65-90K depending on experience + bonus + benefits + share options.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Project Management

    £60000 - £70000 per annum, Bonus + benefits
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    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies. *PHARMA EXPERIENCE REQUIRED*

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has strong budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-70K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.