Reset

Job Search
Filters

Use the options below to filter your job search and trigger a more bespoke result.

Search
  • Internal

    £22,000-£25,000 + commission OTE up to £50,000 in first year
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    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 individuals who can support with our ambitious growth plans for 2020, build on our current success, and become apart of our future.

     

    Why Skills Alliance?

    We have a vibrant office based in the City of London that is growing rapidly. Skills Alliance specialise within Life Science industry and have 6 offices globally with the vison to open another one in 2020. We come to work every day to do something we love and are genuinely passionate about.

    We have a solid reputation in the market and work hard together to help maintain it, with a commitment to rewarding our staff and celebrating successes.

     

    The Trainee Training Academy

    We specialise in training, developing and nurturing our staff which is run by our Global Learning and Development Manager. 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 where the basics of Recruitment are covered and the participants are able to 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:

    • Headhunting and identifying suitable candidates
    • Qualifying candidates
    • Arranging and preparing candidates for interviews
    • Liaising with candidates & clients
    • Business Development
    • Lead & referral generating
    • Learning to become an expect in your market

     

    What skills do you need?

    • Strong communication skills and the ability to develop new business relationships
    • Ability to listen, learn and apply new ideas quickly
    • Previous sales experience would be highly advantageous
    • An interest into the Life Science sector is a bonus
    • Achieving set targets and working to deadlines.
    • Entrepreneurial, ambitious and enjoy a fast paced, but challenging atmosphere.

     

    What we offer:

    • Competitive basic salary: with an average first year OTE of £35,000 – £50,000
    • Career progression:based on meritocracy. We believe in promoting on merit and not tenure. Promotion to consultant /senior consultant within 6-12 months
    • Uncapped commission :structure up to 30%
    • Learning and Development: a supportive and structured environment which includes weekly training delivered by our Global Learning Development Manager and Senior Management Team
    • Benefits:such as flexi time, working from home, private health insurance, corporate gym membership, health & wellness programme, duvet days, ½ day off on Birthdays and a generous vacation allowance
    • Incentives:such as lunch clubs, 2x yearly holiday incentives (previous destinations include Croatia, Ibiza, South of France & Budapest, 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 a Michelin Starred restaurants in London
    • The perks:A fun and vibrant office with perks such as dress down Fridays, office foosball table, beers in the office on Fridays and monthly Director drinks.
    • International office relocation:for people who want to work in our other offices (New York, Seattle, Newport Beach and Zurich)
  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    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.

  • USA

    Competitive Pay + Benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    We are currently working alongside a groundbreaking next generation sequencing technology company, who are looking to bring the power of NGS to help patients around the world. Their non-invasive assay platform has been validated to detect all four major types of genetic alterations known to drive cancers. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry & bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are in search of a Senior Quality Engineer to join their team. This role will serve as the QA representative on development / change teams, Facilitate design control documentation, works with the product management and manufacturing teams, and will be responsible for investigating and documenting DRs/NCRs/CAPAs.

    Qualifications

    • IVD product development, design control and risk management
    • Experience in FDA 21 CFR Part 820, ISO13485, ISO 14971and CE regulatory requirements
    • Experience with an electronic document management or quality management system

    We are moving quickly on this role, so please do not hesitate to apply!

  • UK

    £45000 - £65000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    My client is seeking a Network Analyst to lead overall service management and day-to-day operations of multiple infrastructure services within the networking and communications team.

    My client is an innovative Global Pharmaceutical Company with a reputable name in the Life Sciences Industry.

    Functions:
    – Vendor management- working with 3rd party vendors
    – Cisco switch and router setup and configuration
    – Cisco ASA firewall setup and configuration
    – Knowledge of site-to-site VPN configurations and MPLS network infrastructure
    – Cisco wireless LAN infrastructure design, setup, and management
    – Skype for Business

    Experience: 5 years minimum required in Cisco Network Management (topologies, switches, routers, firewalls etc).

    Qualifications:
    – CCNA: Routing & Switching
    – CCNA: Wireless
    – MCSE

    Salary: £45k – £65k (depending on level of experience)

    Contact
    Email: shakir.h.a4lgdx1gubfh@skillsalliance.aptrack.co
    Phone: 0207 220 6232

  • UK

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

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A leading biopharmaceutical company is looking for a Clinical Records Manager to join their Clinical Operations team. This is an excellent opportunity to join one of the pioneers in the industry with a great reputation in the industry and an ever-expanding and exciting pipeline.

    The role will require international travel on a quarterly basis to meet the client’s provider and liaise with senior stakeholders globally.

    Ideally, you will be experienced in clinical trial documentation from a strong CTA or TMF background. If you have experience in QC that would be an advantage.

    This is a permanent, office-based role in London with 2 days working from home. International travel expenses will be provided by the client.

    Skills Alliance are the preferred suppliers for this role. Please contact Arturo Maldonado on 02036683963 for more information. Alternatively, click APPLY NOW.

  • UK

    £50000 - £65000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working in cell and gene therapy, specifically in Oncology.

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

    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.

  • UK

    £60000 - £70000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join an established Biopharma. Permanent Senior Clinical Study Manager role based in West London and working in one of their leading therapy areas.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for one of their leading TAs, a life threatening area, therefore the opportunity to have a real impact on patients. They will be expanding and will offer great long-term prospects. The company are looking for an experienced PM or Study Manager, ideally with line management experience. This would be working on studies at the cutting edge of science.

    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 60-70K depending on experience + bonus + extensive benefits + stock options.

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

  • UK

    £65000 - £75000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join a fast growing Biotech. Permanent Senior Clinical Trial Manager or Senior Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 65-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / Senior CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £55000 - £65000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or Clinical Study Manager role based in Hertfordshire AND/OR London offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be managing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire AND/OR London with flexibility to work from home. 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 CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £50000 - £60000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join an established Biopharma. Permanent Senior CTA / TMF Manager / Clinical Records Manager role based in West London with flexibility.

    This World-class Biopharma work in a range of life threatening diseases and areas of unmet need. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior CTA or TMF Manager to join the team, this would be working on studies at the cutting edge of science.

    This is a full-time and permanent position. It is office-based in West London with flexibility and will involved quarterly travel. They offer an excellent salary and package around GBP 50-60K depending on experience + bonus + extensive benefits.

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

  • UK

    £30000 - £40000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Quality Systems Associate

    This is a great opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Quality Systems Associate.

    You would be part of a global, well-established and well-known Pharma organisation, which specialises in neurology and oncology. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the company’s vision within the healthcare industry.

    Responsibilities:

    • To support QMS Indicator reports

    • To coordinate GMP training

    • To support improvements to TrackWise processes and systems

    • To support the Deviation System

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Good technical and analytical judgment

    • Ability to maintain a professional behaviour

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 30K-40k, depending on experience.

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

  • UK

    £20000 - £27000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Quality Control Analyst

    This is a great opportunity to join a well-established Pharmaceutical firm, with an extremely strong culture and great opportunities for career progression.

    They are currently looking for a passionate QC Analyst to join their growing QC team and contribute to the development of a variety of medicines and healthcare products.


    Responsibilities:

    • Assisting with the Quality Control of raw materials

    • Working in accordance with prescribed guidelines

    • Working with different analytical techniques

    Requirements:

    • 1 year’s relevant experience in an analytical testing role

    • Experience working with HPLC and GC analysis

    • Excellent communication skills

    This is an office-based position based in Hertfordshire. It is a permanent role offering a competitive salary up to 25K, 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.

  • UK

    £55000 - £65000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Medical Device Quality Manager

    Would you be interested in working with a leading pharmaceutical company as a Medical Device Quality Manager based in West London?

    Now onto a little about the opportunity itself; You would be joining a company with a strong EU presence and an impressive portfolio of devices currently in the pipeline. The role requires an experienced manager with a background in medical device quality systems to develop the quality function and liaise with other directors and board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Acting as a leader of global quality to ensure MDQMS are up to date
    • Coordinating all the processes related to the Medical Device quality system
    • Performing audits in line with ISO 13485
    • Opportunity to support the wider Quality function

    Requirements:

    • Experience at managerial level
    • Experience within medical device auditing
    • An engineering degree or equivalent
    • Strong analytical and communication skills

    This Medical Device Quality Manager role is an office-based position in London. It is a permanent role offering an attractive package, which can be discussed further 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.

  • UK

    £45000 - £55000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Clinical Quality Assurance Manager


    A rare opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Clinical Quality Assurance Manager.

    You would be part of a global, well-established and well-known Pharma organisation, which specialises in neurology and oncology. As the company expands, you will have the capability to progress within your career, as well as contributing towards the development of product portfolios for both business groups.

    Responsibilities:

    • To support audit programs in EMEA region

    • To report and plan GCP Investigator site audits in EMEA region

    • To conduct GCP vendor and GCP System and process audits

    • To maintain CQA Management Program

    Requirements:

    • Excellent auditing and quality knowledge

    • Good knowledge of phase II and III studies

    • Management experience

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 45K-55K and the chance to travel in the EMEA region up to 30% of the time.

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

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Skills Alliance is currently partnered with the leading biotech company based in the northern part of Switzerland. For this purpose, our client is looking for a Lab Technician to join their team on a 1 year contract role.

    REQUIRED QUALIFICATIONS AND EXPERIENCE
    · Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering with 2-4 years BS or 1-3 years MS.
    · Ability to efficiently plan and effectively execute and document analytical experiments in a GMP-compliant pharmaceutical environment.
    · At least 1 year experience in Lab.
    · Basic knowledge of GMP.
    · Good knowledge of sample preparation, HPLC instrumentation and techniques.
    · Basic knowledge of spectroscopic methods, e.g., UV/VIS, IR.
    · Basic trouble-shooting skills for analytical analyses.
    · Flexibility, good communication, time management and team-working skills.
    · Ability to work independently and to take initiative.
    · Life-long learning mindset.
    · Proficient in English.

    RESPONSIBILITIES AND TASKS
    Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.

    The Laboratory Technician in AD/QC will have the following responsibilities and tasks which are related to the company site.

    · Development, optimization and application of analytical methods, e.g., for purity-, stability-, content-, potential genotoxic impurity determinations.
    · Write-up of analytical methods for implementation.
    · Conduct of release, retest, stability studies, transfer and validation analyses.
    · Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
    · Interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
    · Write-up of analytical protocols and reports, e.g., for validation and stability studies.
    · Assurance of adequate maintenance and operation of analytical equipment according to GMP.
    · Drafting and review of CoAs and/or Analytical results sheet.
    · Drafting of SOPs, GUIs, TPLs, FRMs.
    · Training of Laboratory personnel.
    · Ensuring of cleanliness of laboratory and work space.

    Please apply directly here or contact me via phone +41 44 798 2410. Thanks!

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A fast-growing Global gene therapy Biotech company are currently looking for a CMC Gene Therapy Regulatory Affairs Director in Central London.

    The Director will manage the CMC regulatory submissions throughout the lifecycle with minimum supervision, with responsibility for the execution of the regulatory CMC strategy of all submissions.

    Responsibilities:

    • Create regulatory strategy and execute regulatory submissions to support CMC activities of the gene therapy programs

    • Prepare, author, review, coordinate and manage CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports, agency meeting briefing documents and CMC sections of the BLA/MAA in accordance with applicable regulations

    • Closely interact with the analytical development groups, QA, QC and regulatory to deliver successful gene therapy clinical trials and marketing authorizations by providing strategy guidance to the Company on CMC regulatory requirements

    • Act as liaison between Regulatory Affairs and other functional areas at the company, as well as collaborators and vendors to develop CTD modules

    • Represent Regulatory Affairs in cross-functional team meetings and translate current regulatory requirements and proposed CMC changes into practical, workable submission plans and strategies

    Requirements:

    • Demonstrable experience in Regulatory Affairs with a minimum of 6 years in CMC regulatory. Proven track record in CMC gene therapy is preferred
    • Bachelor’s degree in Life Sciences. Advanced Scientific or Process Engineering degree is desirable
    • Comprehensive understanding of FDA, EMA and ICH requirements
    • Experience with delivery of regulatory submissions in eCTD format
    • Ability to manage multiple projects/submissions concurrently.

    This Director Regulatory Affairs CMC position is office-based with some flexibility located in Central London. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A leading European specialist pharmaceutical company are currently recruiting a Regulatory Affairs Manager in medical devices located just outside North West London.

    The role requires a Regulatory Affairs Manager with a background in medical devices to be responsible for developing the regulatory vision for assigned products in order to deliver against the company’s global product strategy and vision.

    Responsibilities:

    • Keep strategic oversight of regulatory changes that impact assigned products, ensuring that regulatory projects are organised in alignment with the product vision
    • Maintain up to date knowledge of relevant regulations, guidelines and industry standards, advising as to their interpretation and propose strategies for effective implementation
    • Identify potential changes that are being discussed in cross functional meetings and feed these into Regulatory Change Triage for assessment and inclusion within the long-term planning of workload
    • Integrate new products into operational plans, ensuring that product visions are understood, and regulatory strategies are put in place, so that routine maintenance can be handed over to Regulatory Change Leads
    • Mentor and advise Regulatory Change Leads and delivery team members to ensure that the planned regulatory strategies are followed and any roadblocks that require product or regulatory expertise are resolved and escalated as necessary
    • Co-ordinate QMS related regulatory activities e.g. CAPA’s as applicable, to ensure compliance with actions
    • Support inspections and audits, as applicable

    Requirements:

    • Minimum BSc and MSc or PhD or PharmD or M.D. in science or healthcare preferred or equivalent relevant experience
    • Must have demonstrable experience managing product portfolios within a Regulatory Affairs global position.
    • Considerable regulatory experience with EU regulatory requirements and processes (MRP, DCP and CP) for post approval activities. Experience with AU and NZ preferred
    • Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
    • Aspires to continuously develop technical/professional knowledge and interpersonal/management expertise to be a good role model

    This Regulatory affairs manager position is a office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A Leading global Biopharmaceutical company are recruiting for a Regulatory Affairs Senior Manager position based in the Benelux region.

    This is an opportunity to be a part a growing International Regulatory Affairs team that are paving a new way to develop medications to deliver to patients across the globe. The rapid growth of the company is accompanied by excellent career progression opportunities.

    Responsibilities:

    • Review the draft guideline for EU and provide the comments on the draft guidance for EU environment shaping
    • Sensing the EU regulatory change/trend and collect the regulatory intelligence and update the EU regulatory environment change
    • Develop EU specific SOPs and manuals in line with EU regulation/guidance and internal process
    • Provide regulatory strategies, risks and mitigations
    • Act as a local representative for clinical trial application in EU
    • CRO management on regulatory compliance submission (e.g. PSUR submission, pharmacovigilance)
    • Manage/support the regulatory procedure/document preparation including MAA, post-approval activities (e.g. EU document request, CPP request, legalisation, notarisation etc.)
    • Draft final labelling/artwork components for regulatory submissions/commercial purpose

    Requirements:

    • At least 4 years’ experience in relevant fields
    • Good breadth of understanding of the European regulations
    • Project management experience is preferred
    • A Bachelor’s degree in science or related fields

    This Regulatory Affair Senior Manager position comes with a competitive salary of £80,000 – £86,000 and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A Leading global Pharmaceutical company are recruiting for a Senior Manager Global Quality Operations in Hertfordshire.

    This is a unique opportunity to improve the company’s quality systems, inspection management, regulatory intelligence activities and many more.

    Responsibilities:

    • Pharmacovigilance Audits – Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities
    • Plan, supervise, conduct, and support internal and external GxP audits
    • Maintain a tracking tool for audits, findings and corrective and preventive actions
    • Quality System –
    • Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
    • Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV.
    • Collaborate with the respective Functional Area Heads/representatives
    • Ensure SOPs/ WPs are compliant with applicable requirements and regulations
    • Support the preparation for GxP inspections
    • Support the responses to Regulatory Authorities
    • Regulatory Intelligence – Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of the company’s procedures.

    Requirements:

    • Degree in natural science or equivalent number of years’ experience
    • Experience in Pharmacovigilance auditing (Qualification as an auditor preferred)
    • Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation
    • Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance
    • Experience in Monitoring, Quality Assurance and/or Good Clinical Practices
    • Exposure to inspections

    This Senior Manager Global Quality Operations position is an office-based position. It Is a permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details or click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A Leading global Biopharmaceutical company are recruiting for a Regulatory Affair Manager/ Senior Associate position.

    This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability. They work in a range of area specialising in Cell Therapy and Oncology.

    Responsibilities:

    • Working with the European regulatory product lead for a development product, prepares regulatory documentation as required, in accordance with Regulations, guidance and legal obligations
    • Preparation and co-ordination of the regulatory documentation to support clinical trial applications and amendments, in the European Union
    • Working with the European regulatory product lead to ensure when licensed the product packaging and associated information is updated and maintained in accordance with Marketing Authorisation including the review and management of labelling translations and artwork
    • Interaction with the Regulatory, Clinical Research, Clinical Operation and other function to ensure optimal execution of the agreed regulatory strategy for development medicinal products.

    Requirements:

    • Experience in the preparation and submission of Regulatory documentation to support centralised MAA procedure and post approval activities
    • Knowledge and experience relating to clinical trials and clinical trial applications
    • Good breadth of understanding of the European regulations
    • Experience representing Regulatory Affairs on cross functional teams is desirable
    • Degree in biological or life sciences, pharmacy or medicine (or international equivalent)

    This Regulatory Affair Manager/ Senior Associate is a permanent role offering around £50-60K + benefits, office based in Cambridge or Stockley Park with flexibility.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Would you be interested in working with a leading global CRO company as a Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing International Regulatory Affairs team with an impressive clientele list.. The rapid growth of the company is accompanied by excellent career progression opportunities

    Responsibilities:

    • Management, preparation, assembly and submissions of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments
    • Country-level Informed Consent and other patient facing documentation
      • Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.

    Requirements:

    • 6 – 12 months of industry experience in a Regulatory environment
    • Good of understanding of all aspects of CTA submissions
    • Science graduate

    This Regulatory Affair Senior Associate position comes with a competitive basic salary + benefits

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £45000 - £50000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share



    Would you be interested in working with a leading global CRO company as a Senior Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    Responsibilities:

    • Management, preparation and submission of EU CTAA
    • Tracks, reports and files CTAA and amendment submission/approval progress in eTMF and CTMS
    • Participates in quality control
    • Serves as a key Regulatory liaison on behalf of the company

    Requirements:

    • At least 2 – 3 years’ experience in relevant fields
    • Good breadth of understanding of all aspects of CTA submissions
    • Oncology experience
    • A Bachelor’s degree in life sciences
    • Strong analytical and communication skills

    This Senior Regulatory Affairs Associate role is an office-based position in West Sussex. It is a permanent role offering an attractive salary between £45,000 – £50,000 + benefits per annum, depending on experience.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £55000 - £60000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Would you be interested in working with a leading global CRO company as a Senior Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing International Regulatory Affairs team with an impressive clientele list.. The rapid growth of the company is accompanied by excellent career progression opportunities.

    Responsibilities:

    • Management, preparation, assembly, submission and full oversight for:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • All other regulatory and patient facing documents required to support ongoing approval of clinical trials, including all required translations, in accordance with the required current legislation and guidelines.
    • Tracks, reports, files and maintains oversight of CTAA and amendment submission / approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Ensures all CTAAs and amendments are submitted in accordance with clients’ timelines.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by RAs and ECs.

    Requirements:

    • 4 – 5 years of Regulatory experience
    • Good of understanding of all aspects of CTA submissions
    • Expert knowledge of ICH-GCP and local regulatory agency and ethics committee regulations and requirements
    • Science graduate

    This Regulatory Affair Officer position comes with a competitive basic salary of up to 60K + benefits and 40% home working (2 days per week).

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A leading European specialist pharmaceutical company are currently recruiting a Pharmacovigilance Audit Manager located just outside North West London.

    The roles requires the manager to provide QA leadership and oversight for PV and device vigilance audit activities, including support the establishment and maintenance of a risk-based audit strategy; oversight of any contracted audits; and reporting on the PV and device vigilance risks, trends and effectiveness of the systems within the pharmacovigilance universe at the company.

    Responsibilities:

    • Conducting audits in line with PV and DV requirements in accordance with the global risk-based audit program and ensure any gaps are identified and reported to responsible management
    • Deliver the global risk-based audit program across the PV universe to ensure effective QA oversight of the companies PV activities
    • Plan and conduct and close out PV audits of processes, affiliates and third parties including service providers and partners
    • Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements
    • Participate in and support PV inspections and DV aspect of notified body audits where applicable
    • As PV auditor, the individual will have close interactions with partners, third parties and varied functions within and external to Norgine

    Requirements:

    • A scientific degree is essential with at least relevant experience of Pharmacovigilance, of which some should be in PV QA.
    • Specialist knowledge of pharmacovigilance and PV QA within the pharmaceutical industry.
    • Proven experience in oversight of Pharmacovigilance QA activities for commercial marketed product
    • Experience supporting partner audits and competent authority PV inspections
    • Proven experience in auditing a wide range of GVP processes and suppliers
    • Medical Device Vigilance experience is desirable

    This PV Audit Manager position is a office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £55000 - £60000 per annum, Car Allowance + Bonus + Extensive benefits package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    An exciting young biopharma is looking for a Clinical Project Manager to join them in their London office on a 10-month fixed-term contract and manage a large global study in liver disease.
    This is an excellent opportunity to join a leading organisation with a great reputation in the market in this niche area.

    The role would involve overseeing this large global study in their EU and Asia-Pac sites, working closely with the US team. It is a pivotal phase III trial and they have just completed recruitment, so you would be joining at an exciting time!

    Key Requirements:

    • More than 6 years’ working in clinical research for pharmaceutical, biotech, or CRO company
    • Minimum 2 years of clinical project management experience
    • Ability to work with initiative and be dynamic and adaptive
    • Able to start immediately or by December latest

    This is an Exclusive role with Skills Alliance. Please contact Arturo Maldonado on 0203 668 3963 for more details or alternatively click APPLY NOW.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Data Visualisation Analyst/Power BI Developer (Contract) role for a Global Medical Device company.

    The Data Visualisation Analyst position will be responsible for building reports and dashboards to support the Financial and Commercial Reporting workstreams.

    Duration: 3 Months
    40 hours per week

    Rate: £45 – £60 p/h (dep. on experience)

    Location: Watford

    Key Responsibilities include:

    • Build new visualisations in Power BI to demonstrate business performance and uncover opportunities.
    • Create Power BI dashboards and reports regularly and perform quality checking to ensure accuracy.
    • Explain data, visualisations, their meaning and application to the technical and non-technical business users.
    • Engaging with the business and leadership on requirement definition.
    • Working with end users to create mockups and design documents.
    • Create and update design documents in Confluence.

    • Create visually appealing and interactive data visualisations that drive action within the business using Power BI.
    • Publish new dashboards and reports using Power BI.
    • Support the UAT process and conduct the initial round of testing.
    • Document new dashboards when they are created.
    • Work with IT to test and incorporate new data sources as they become available.
    Beyond the core responsibilities, it is expected that the candidate will be able to direct users in the essential operation of Power BI and assist and train users in the interpretation of visualisations.

    Would this be a role for your interest?

    If so, please contact me via

    Email: shakir.h.a4lgdx1gucb4@skillsalliance.aptrack.co
    Phone: 0207 220 6232

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A leading European specialist pharmaceutical company are currently recruiting a Regulatory Change Lead / Project Manager located just outside of North West London.

    The role requires a Regulatory change lead / Project manager to be responsible for the project management of assigned post approval regulatory activities. This includes; forming and leading the delivery team through the planning of assigned projects: ensuring that high quality documentation is prepared for regulatory submissions in partnership with our Regulatory Service Providers: liaising with relevant departments and third parties to ensure regulatory requirements for these submissions are met.

    Responsibilities:

    • Organise kick-off meetings as required for assigned projects, engaging the relevant team members to plan and implement the change
    • Prepare and agree plans for implementation of regulatory activities within agreed timelines for change control
    • Work in collaboration with the Regulatory Affairs Managers to understand and align with agreed product strategies
    • Ensure that high quality documentation is prepared for submission following current best practice standards and meeting requirement guidelines
    • Anticipate and resolve complex regulatory issues, engaging Regulatory Affairs Manager as required
    • Ensure any post approval commitments are logged and followed up on
    • Liaise with relevant internal departments and external contacts to ensure regulatory requirements are met and to proactively communicate with regulatory authorities where required in order to expedite approval of submissions

    Requirements:

    • Excellent verbal and written communication skills, proficient presenting complex projects in a relevant and meaningful way to others.
    • Good degree in a relevant life science subject or equivalent Project Management qualification with demonstrable experience working within the Pharmaceutical sector and in a regulatory environment.
    • Strong facilitation skills, with the ability to coordinate a multi-disciplinary team to deliver against agreed plans
    • Proven ability to project manage multiple small and large projects within the regulatory affairs environment

    This Regulatory Change Lead / Project manager position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A leading European specialist pharmaceutical company are currently recruiting a Medical Device Expert located just outside of North West London.

    The Medical Device Expert would be responsible for activities requiring in-depth knowledge of regulations and regulatory requirements in relation to Medical Devices post CE approval, as well as assessments of Medical Devices and In-vitro Diagnostic and Active Implantable Medical Devices.

    Responsibilities:

    • Maintain up to date knowledge of relevant regulations, guidelines and industry standards, proactive communicate to internal stakeholders in writing and presentations to disseminate and discuss the interpretation and implementation
    • Provide expert advice and support to Brand Teams, cross functional Medical Device project team, and other area of the business, and communicate any changes required to Medical Devices RA Manager
    • Provide expert advice and support to due diligence activities as requested
    • Explore opportunities for continuous improvement to enhance business performance
    • Interrogate and sanity check audit preparation and participate in internal and external audits to ensure and sanity check successful re-certification of products.
    • Provide training of Medical Device cross functional project team members in Medical Device requirements as deemed relevant

    Requirements:

    • Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
    • Able to contribute to budget preparation and review
    • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
    • Must have expertise in the development, certification and maintenance of medical device products
    • Clear communicator, sharing information to ensure successful partnering with internal and external stakeholders. Listens and responds effectively to others
    • Responds quickly and positively to customer needs, develops effective collaborative working relationships with customers/external partners

    This Medical Device Expert position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £40000 - £50000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager or Junior Clinical Study Manager role based in London and working in cell and gene therapy.

    This exciting and innovative Biopharma are at early stages with trials working in a range of disease areas in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced CRA or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science.

    This is a full-time and permanent position. It is office-based in London with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 40-50K depending on experience + bonus + extensive benefits.

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

  • UK

    £55000 - £65000 per annum, excellent package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager, this would be working on interesting early phase studies. They require clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. 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 CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    Competitive Salary and benefits package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Skills Alliance has been exclusively retained by a specialty pharmaceutical company to hire a Microbiology Manager, to provide leadership and guidance to the function as they prepare for an FDA audit later this year.

    Our client is committed to delivering specialty CNS products and enjoys both global and national partnerships with healthcare providers and facilities. The Microbiology Manager will be part of the FDA readiness project team and will act as the head representative for inspections. The role is highly visible and will be the subject matter expert, reporting to the UK Quality Director.

    The Microbiology Manager will facilitate the compliance of appropriate GMP/GLP requirements, provide Microbiology support to the Quality team in the event of an environmental excursion and mitigate current and future compliance risks. Experience with MHRA inspections is a must, with FDA inspection experience desirable.

    Job Responsibilities:

    • Lead and direct the Microbiology team and ensure all activities are in line with agreed SOPs
    • Act as subject matter expert for Microbiology and review/enable documents (SOPs, Validation Protocols) on behalf of the Microbiology team
    • Provide appropriate solutions to current and future compliance risks
    • Ensure the testing of products and materials are both on time and conform to SAP lead times
    • Manage CAPAs, non-conformances, change controls and customer concerns
    • Direct audits on CROs conducting outsourced Microbiology activities
    • Communicate any legislative and guideline changes issued by Health Authorities to the Microbiology team
    • Act as a representative for both internal and external quality audits, ensuring recommendations are quickly implemented
    • Be involved in meeting company objectives including KPIs
    • Provide training and mentorship to employees
    • Budget management for the Microbiology team


    Qualifications:

    • Scientific degree
    • Project and people management experience within a pharmaceutical company
    • Experience with MHRA audits and both internal and external audits
    • Experience in Aseptic Environmental Monitoring
    • Strong knowledge of product licensing activities and EU Regulatory guidelines


    Skills Alliance is exclusively partnered with this quality driven pharmaceutical company. Please click APPLY or call Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

  • Competitive Salary and benefits package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire a CMC Technical Writer to join their growing CMC team.

    The company has an innovative and active research pipeline focused on developing biologics for the treatment of rare autoimmune conditions and oncologic diseases. The biotech’s pipeline is advancing with global phase III trials underway.

    The CMC Technical Writer will create and evaluate quality submission packages for the company’s therapeutic drug candidates in phases I-III towards their market approval. As the function continues to grow, there is an opportunity to become involved in CMC development strategies and take on further CMC responsibilities of interest. The role reports to the Head of CMC and will be based in Belgium.

    Responsibilities:

    • Author technical materials for drug development activities
    • Create and prepare materials (IMPD, IND, Investigator Brochures, etc.) for therapeutic compounds being developed, in close collaboration with internal and external stakeholders
    • Create and prepare quality documentation packages (ex. Common Technical Documents, Biologics License Applications and Marketing Authorisation Applications) for Modules 2 and 3
    • Ensure the completion and compliance of submission packages in line with regulatory and country-specific requirements
    • Keep track of the execution of regulatory requirements
    • Provide strategic insights into CMC development activities
    • Involvement in CMC development of pre-clinical and clinical programs and collaboration with other function members

    Qualifications:

    • Master’s Degree or PhD in relevant field of study
    • Strong competence in CMC development and creation of regulatory dossiers (e.g. INDs, MAAs)
    • Large molecules experience preferred
    • Knowledge of ICH guidelines, pharmacopoeial requirements, and local and international regulatory agency guidelines (FDA, EMA)
    • Ability to collaborate and build strong relationships with external and internal stakeholders
    • Proficiency with MS Word and other document management programs

    Skills Alliance is exclusively partnered with this innovative biotech. Please click APPLY or contact Karina Sharipova at 0044 207 220 6205 to receive further information, including a full job description.

  • UK

    Up to £40,000 + Strong bonus + Extensive benefits package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    My client is a leading global pharmaceutical company who is looking for a Senior TMF specialist to join their exciting team. This is an opportunity to join one of the leading players in the Neurology and Oncology field, being actively part of a highly dynamic clinical team.

    Key Responsibilities:

    • Monitor and maintain clinical trial documents and data for global scope trials across all clinical phases
    • Meeting and liaising with study teams from both the UK and the US
    • Quality Control (QC) of studies including starting the study, maintaining the QC and close out of the study
    • Liaising with the company vendor and their CRO, maintaining stakeholder management

    Key Requirements:

    • At least 4 years in the pharmaceutical industry, working within clinical development/operations
    • Strong experience with clinical document management (TMF,eTMF and QC required)
    • Excellent organisational and communication skills
    • Life Science degree to BSc level minimum

    Skills Alliance are the preferred supplier for this role. For more information please contact Arturo Maldonado on 02036683963 or alternatively click APPLY NOW.

  • UK

    Competitive Salary + Bonus + Benefits Package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A global CRO are looking for a study-start up associate to join their dynamic clinical operations team. This is an excellent entry opportunity to join a leading organisation focused primarily in Oncology clinical studies. Although a small organisation, they have a strong reputation worldwide for their work in early phase studies (I-II), and support emerging biotechs and global pharma companies to identify the most promising cancer therapies.

    Key requirements:

    • Recent life-science graduate
    • 6 month industry experience in associate roles such as a CTA would be an advantage.
    • Those with a clinical background if shorter are also encouraged to apply!

    This is a permanent, full-time, office-based role in Crawley. A full job specification and package details are available on request.
    This role offers excellent long term prospects in clinical operations and can kickstart your career in the industry.

    Skills Alliance are the Exclusive partners for this role. Please contact Arturo Maldonado on 0203 668 3963 for a confidential discussion. Alternatively, click APPLY NOW.

  • UK

    £75000 - £85000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Head of Quality Control

    I am currently partnering with a leading global pharmaceutical company who are currently looking to appoint a senior level person for a Director position within the quality department.

    This is a rare opportunity for an experienced Director with an extensive background in Quality Control to develop the quality function and work at a strategic level, while ensuring good maintenance of the laboratory in accordance to agreed guidelines. The role is with an innovative and well-established pharmaceutical company. They have a very strong company culture and will offer excellent long-term prospects as well as global exposure.

    Responsibilities:

    • To manage materials and packaging in accordance with GMP guidelines
    • To coordinate all laboratory processes and equipment
    • To ensure that all OOS and OOT results are investigated according to agreed guidelines
    • To manage all QC related projects
    • To oversee and support other EU based laboratories

    Requirements:

    • Minimum 5 years management experience
    • Extensive knowledge of QC and QA
    • 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 very attractive package on offer.

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

  • UK

    £40000 - £50000 per annum, 2x yearly bonus + extensive benefits package
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A specialist and niche patient recruitment company are looking for a manager to join their exciting and ever-growing patient recruitment team.

    This is an excellent opportunity to join a fast-paced and friendly patient recruitment company in clinical research who work closely with their extensive CRO and pharma clients

    The role is Office-based in Hertfordshire, but there could be home-based consideration. This is a permanent position on a full-time basis.

    Key responsibilities:

    • Managing patient recruitment and retention programmes for projects for main clients and in-house staff
    • Management of third-party vendors
    • Involvement in budget management
    • Active role in business development activities

    Key Requirements:

    • Extensive experience in patient recruitment or deriving patient recruitment strategies, can be in industrial or a healthcare setting
    • Experience working with numerous stakeholders on multi-regional project
    • Degree in life sciences
    • Proficient in Microsoft package

    Skills Alliance are the preferred suppliers for this role. For more information please call Arturo Maldonado on 02036683963 or alternatively click APPLY NOW.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    A Global Pharmaceutical company focusing on the manufacturing and distribution of Generics through the differing business arms allowing them to provide medicinal solutions from production through to supply chain.

    This organisation is currently going through some expansion plans, diversifying their portfolio and looking at new countries, in which to offer solutions to more patients.

    With this in mind they are currently looking to recruit a Packaging and Validation Specialist with the following skill set:

    • Educated to degree level (Science)
    • GMDP working knowledge/experience
    • Cleaning Validation experience
    • Supported pharmaceutical site validation activities (VMP)
    • Report writing
    • Experience in supporting pharmaceutical site change control activities
    • Leadership and training skills
    • Ability to engage with internal and external stakeholders and build relationships

    If you are interested in learning more about this opportunity, please submit your CV and I will contact you with the details.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Would you be interested in working with a leading global CRO company as a Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing International Regulatory Affairs team with an impressive clientele list.. The rapid growth of the company is accompanied by excellent career progression opportunities

    Responsibilities:

    • Management, preparation, assembly and submissions of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments
    • Country-level Informed Consent and other patient facing documentation
      • Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.

    Requirements:

    • 6 – 12 months of industry experience in a Regulatory environment
    • Science graduate

    This Regulatory Affair Senior Associate position comes with a competitive basic salary + benefits

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    I am currently partnering with a company at the cutting edge of scientific advancement in healthcare, working to bring leading technology to the market that will help medical professionals characterise and diagnose a variety of genetic diseases.

    As an organisation, they are steadily growing and due to some changes are currently looking to appoint a QA Team Leader to manage the QMS and overall Quality function alongside the Quality Director.

    This role will offer the ability to have an impact on the decisions effecting the Quality function, have autonomy of your work and see the end result to the changes implemented across the Quality function.

    The Key responsibiities for this opportunity would be:

    • Managing department reports including company quality objectives and communicating these company-wide
    • Managing the timely reporting of non-conformities and CAPA Management
    • Managing review of new and existing suppliers
    • Preparation of quality assurance documentation
    • Assisting with risk management activities
    • Assisting in managing project plans, design and development files and medical device files
    • Assisting in internal and external audits
    • Assisting with completion of technical and regulatory documentation

    The experience required for this position would be:

    • Experience of working with ISO 13485 quality management systems
    • Experience of dealing with non-conformities and CAPA management

    Skills Alliance are the preferred supplier for this role. CLICK TO APPLY NOW.

  • UK

    Dependent on experience
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    Are you a Qualified Person looking for an opportunity to work within a well known organisation?

    Open to an opportunity where you get to work with both internal and external departments of a business?

    Then this could be the ideal position for your next career move.

    The main function of this role will be:

    • To carry out the duties and responsibilities of a Qualified Person as detailed in EU Directive.
    • To ensure the principles and responsibilities of GMP / GMDP, as stated in Directive 2003/94/EC and interpreted.
    • Ensure the EU Guide to GMP have been followed and perform the duties of the responsible person as per MHRA and EU regulations.
    • To review the batch documentation for pharmaceutical products and subsequent batch disposition, including certification for release.
    • Sampling, inspection, batch processing and approval of bought-in products.
    • Liaise with contract laboratories and review of data generated, following analysis.
    • Review of data generated by temperature monitoring equipment received with deliveries.
    • Investigations into customer complaints.
    • Management of recalls of pharmaceutical products for the market.
    • Internal and external inspection programmes and to represent the department during regulatory inspections.
    • Review and processing of expired inventory, returns and rejects.
    • Maintain communication with third party warehouse, suppliers and line management.

    You’ll also require the following skills and experience in order to be eligible for the role:

    • A UK or EU registered Qualified Person
    • BSc in Pharmacy or related science
    • Solid experience working within Quality Assurance
    • Experience of Analytical Method Transfers
    • Experience of new product introductions / transfer of QP release activities
    • Experience liaising with the MHRA/ EMA / FDA
    • Have an understanding of pharmaceutical Quality Management Systems relevant to complaints handling and investigations
    • Excel working in a team environment
    • Experience using SAP, Trackwise and Documentum
    • Have good organisational skills

    Skills Alliance are the preferred supplier for this role. If this role looks to be of interest CLICK TO APPLY NOW for a further discussion.