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  • Internal

    £22,000 -£25,000 + commission OTE up to £50,000 in first year
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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 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 vision 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)
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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.

  • Competitive Salary and benefits package
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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire a GCP Quality Manager. With multiple global trials underway, this position will provide GCP guidance to clinical study teams.

    The company has an innovative and active research pipeline focused on developing biologics for the treatment of rare autoimmune conditions and oncologic diseases. Their pipeline is advancing with multiple assets and a high-profile external collaboration in phases I-III.

    This position will play a pivotal role in leading the clinical study team across all quality matters, provide oversight of audit conduct and ensure GCP inspection readiness. This is an opportunity to provide strategic input into the monitoring and reporting of quality metrics. The role is office-based in Belgium and reports to the Head of Quality.

    Responsibilities:

    • Educate the clinical study team on clinical related quality matters
    • Lead the implementation of quality requirements across phase I-III clinical studies
    • Create and execute study quality plans, audit programs, study risk management plans and risk responses
    • Lead study-specific audit site selection processes and supervise the audit conduct, reporting and review in line with company processes
    • Contribute to lead inspection readiness activities and GCP audits
    • Lead investigations into study quality events and define corrective and preventative measures to such events
    • Monitor quality risks and outline risk limiting measures for studies, sites and vendors
    • Produce GCP quality metrics from real-time quality reporting and monitoring, working closely with the clinical study team
    • Ability to collaborate and build strong relationships with external and internal stakeholders

    Qualifications:

    • Several years’ experience in clinical quality management
    • Extensive knowledge of ICH, EU and FDA clinical regulations and guidelines
    • Outstanding communication skills and proven track record of leadership and accountability
    • Fluency in English

    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

    £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 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

    £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 in late phase.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Late Phase team to work on a wide variety of trials. 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. The candidate would need phase III or phase IV experience and be interested in observational studies.

    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 preferred 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

    £70000 - £80000 per annum, excellent package
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    A very exciting opportunity to join a growing Biopharma. Permanent Late Phase Associate Director / Program Manager role based in West London offering an excellent salary and package.

    This exciting and innovative Biopharma have many products on the market and a very strong pipeline. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Program Manager or Associate Director, this would be working on a variety of late phase phase studies. They require a substiantial clinical trial management background, line management and strong and recent non-interventional trials experience.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work from home. They offer an excellent salary and package around GBP 75-90K depending on experience + bonus + extensive benefits.

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

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    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 Senior QA Manager – Auditor with the following experience:

    • Work on internal/external GMDP audits covering Third-Party Manufacturers, Laboratories, Warehouse and Logistics.
    • Complete QTAs
    • Stability Report Reviews
    • Risk Assessments
    • Work with CMOs

    If this role looks to be of interest and you would like to have an informal conversation to discuss your current situation and whether this position aligns well with your career progression plans, please submit your CV and I will contact you with more information

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    A global pharmaceutical company are currently sourcing for a Regulatory Affairs Manager located in their Yorkshire offices. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability.

    Responsibilities:

    • Review, incl. advising and assessment of registration dossiers (esp. Module 1) prior to each submission step during the filing process for in-licensed developments with UK as the leading country
    • Preparation (esp. Module 1), submission and coordination of national and European registration procedures
    • Preparation, submission, coordination and monitoring of national phases of European Registration procedures, including national texts
    • Preparation (Module 1), Submission and Coordination of national and European variations and renewal procedures and/or response documents to deficiency letters
    • Maintenance and communication with internal and external contacts and interfaces, e.g. European Authorities, European affiliates, Headquarter and partners/customers (e.g. NHS, MHRA)

    Requirements:

    • Study / Degree in Pharmaceutical Sciences, Life Sciences or Natural Sciences with at least three-year experience in EU Regulatory Affairs incl. New Applications,
    • Experience with MHRA is preferred
    • Experience in project management is beneficial
    • Fluent in English is essential as it is used as the main communication language
    • Good knowledge of MS Office and of RA eSubmission tools are an advantage

    This Regulatory Affair Manager is a permanent role offering a competitive salary and benefit package located in Yorkshire.

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

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    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.
      • Serves as key regulatory liaison for multi-continental project on behalf of the company (Oncology (Europe). Liaison with other departments within the company, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
      • 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:

    • Science graduate with at least 6-12 months of industry experience in a regulatory environment.
    • Completion of The company’s Oncology training programme
    • Detailed Knowledge of ICH-GCP and local regulatory agency and ethics Committee regulations and requirements
    • The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities

    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

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    A Leading global full service CRO are currently recruiting for a Regulatory Affair Manager or Associate Director in their London offices.

    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 Oncology, Cardiology, Metabolic diseases and many more.

    Responsibilities:

    • Project management focus to facilitate full global regulatory submissions which will include:
    • Tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs;
    • Maintaining timelines for full regulatory submissions;
    • Providing regulatory advice and guidance to other departments to ensure compliance with EMA regulations and requirements;
    • Interaction with EMA and other regulatory agencies;
    • Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA; and
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

    Requirements:

    • Bachelor’s degree and significant regulatory affairs experience;
    • CMC experience preferred;
    • Experience with EMA and other regulatory agencies is preferred;
    • Strong computer skills, project management skills, and a high attention to detail;
    • Strong communication skills (both written and oral); and
    • Must be a team player with a global regulatory mindset.
    • This position may require supervision of junior level staff.

    This Regulatory Affair Manager or Associate Director position is a permanent role offering a highly competitive salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 or click APPLY NOW

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    A global pharmaceutical company are currently sourcing for a Regulatory Affairs Manager located in their Cambridge offices. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability.

    Responsibilities:

    • Review, incl. advising and assessment of registration dossiers (esp. Module 1) prior to each submission step during the filing process for in-licensed developments with UK as the leading country
    • Preparation (esp. Module 1), submission and coordination of national and European registration procedures
    • Preparation, submission, coordination and monitoring of national phases of European Registration procedures, including national texts
    • Preparation (Module 1), Submission and Coordination of national and European variations and renewal procedures and/or response documents to deficiency letters
    • Maintenance and communication with internal and external contacts and interfaces, e.g. European Authorities, European affiliates, Headquarter and partners/customers (e.g. NHS, MHRA)

    Requirements:

    • Study / Degree in Pharmaceutical Sciences, Life Sciences or Natural Sciences with at least three-year experience in EU Regulatory Affairs incl. New Applications,
    • Experience with MHRA is preferred
    • Experience in project management is beneficial
    • Fluent in English is essential as it is used as the main communication language
    • Good knowledge of MS Office and of RA eSubmission tools are an advantage

    This Regulatory Affair Manager is a permanent role offering a competitive salary and benefit package located in Cambridge.

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

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    Would you be interested in working with a leading global CRO company as a Regulatory Affairs Officer 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.
    • Participates in the quality control (QC) steps and ensures each submission has been checked by an appropriately qualified member of the companies regulatory group prior to submission.
    • Ensures all queries raised by Ethics Committees (ECs) and regulatory authorities (RAs) are addressed within required timeframes, including management of applicable negotiations.
    • Maintains metrics on a monthly basis of all regulatory submissions made by the company.
    • Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
    • 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:

    • Science graduate with at least 4 years of industry experience in a regulated environment with CT RA and EC submissions in 2 or more countries.
    • Expert knowledge of ICH-GCP and local regulatory agency and ethics committee regulations and requirements
    • The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities

    This Regulatory Affair Officer position comes with a competitive basic 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

    Excellent Salary + Car Allowance + Strong Bonus and Benefits
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    A leading global pharmaceutical company is looking for a Clinical Program Manager to join their exciting clinical operations team. You would be working on a multitude of European trials mostly across complex oncology and cancer therapy areas.
    This is an excellent opportunity for an experienced clinical programe manager to expand their leadership experience in a senior position within a dynamic organization.

    Key Responsibilities:

    • Manage all aspects of assigned global trials within designated program budgets and timelines
    • Provide program-level oversight to vendors, such as CRO, central lab, and imaging
    • Protocol development, feasibility, set-up and conduct.
    • Directly line manage a small clinical team, including recruit, hire, mentor and management.
    • Travel may be required occasionally to Europe

    Key Requirements:

    • Clinical project and programe management experience
    • Oncology experience essential
    • Solid line management experience including management and mentoring of junior staff
    • Strong vendor management and project oversight experience

    Skills Alliance are the exclusive suppliers for this role. A full job description is available on request. Please contact Arturo Maldonado on 02036683963 for more information, or alternatively click APPLY NOW

    Please note if you have not heard back on your application within 48 hours then unfortunately you have been unsuccessful on this occasion.

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
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    My client is a leading global CRO that are looking for a Senior CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Strong independent monitoring experience as a CRA in a commercial setting (CRO or Pharma)
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • Strong Competitive Salary + Excellent Bonus and Benefits
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    Skills Alliance are partnered with a leading Contract Research Organisation are looking for a Senior CRA to join them exclusively on-site in their Milan office.
    This organisation offers a full-service of clinical trial and pharmaceutical solutions from concept to commercialisation for their commercial clients.

    The role of the Senior CRA would be directly involved in submissions and classic independent monitoring activities associated with a CRA role. You would be required and should be capable of performing a wide range of site visits from SIVs all the way through to Close-out/Exit. The Senior CRA should also be willing to travel nationally for the role in Italy and capable of committing to potential overnight stays.

    Key requirements:

    • 4 years minimum of independent monitoring experience for pharmaceutical, biotechnology or CRO
    • Willing to be fully office-based in Milan, Italy
    • Submissions experience – Ethics and Regulatory
    • Oncology experience – Rare Diseases, Advanced/Gene Therapies or Transplantation experience would be desirable. Rheumatoid Arthritis experience also desirable

    This role offers a superb remuneration package including a strong and competitive basic salary with additional bonus and excellent benefits package.

    A full job description is available on request. Please contact Arturo Maldonado on +44 203 668 3963 for more information.

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
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    Share

    My client is a leading global CRO that are looking for a Senior CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Strong independent monitoring experience as a CRA in a commercial setting (CRO or Pharma)
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • Strong Competitive Salary + Bonus and Benefits
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    Skills Alliance are partnered with a niche Contract Research Organisation who are looking for an experienced CRA to join them exclusively on-site in their Nice office in France.
    This organisation offers a full-service of clinical trial and pharmaceutical solutions from concept to commercialisation for their commercial clients.

    You will be required to set up and monitor clinical studies at the level of the investigational sites directly or via the coordination of the local CRA network by guaranteeing the quality of the data collected, the rights of patients involved in clinical trials and compliance with regulations with the investigators.

    This role is more of a lead position as a CRA and would not involve as high a frequency of monitoring visits as a traditional CRA. The role has a strong focus in developing and training and mentoring junior staff on the client’s SOPs. Therefore, a CRA with a lot of experience through external companies will be a strong fit. You will also be coordinating studies and CRAs across multiple European countries and be required to make contracts with some freelance CRAs. This is a CRA role with less monitoring and more hands-on fieldwork and management.

    Key requirements:

    • 2 years minimum of independent monitoring experience as a CRA for pharmaceutical, biotechnology or CRO. CRO preferred.
    • Willing to be office based in Nice, France
    • Driving license and car – must be willing to travel nationally
    • Fluent in French and English. Desirable languages also include Spanish, Italian, Czech and Polish
    • Ophthalmology experience would be desirable but not essential. Experience in Medical Devices useful.

    This role offers a strong remuneration package including a strong and competitive basic salary with additional bonus and excellent benefits package.

    A full job description is available on request. Please contact Arturo Maldonado on +44 203 668 3963 for more information.

  • UK

    £50000 - £60000 per annum, Strong Bonus and Extensive Benefits Package
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    A leading Biopharma in London are hiring for a Clinical Project Manager to join and manage trials in their exciting late-phase unit. The role would be working and managing trials in this area across a variety of different therapeutic areas and working on their vast and extensive pipeline.

    Key Responsibilities:

    • Provide support and oversight of Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
    • Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
    • Contributes to development and maintenance of study budgets.
    • Contributes to development of RFPs and participate in selection of CROs/vendors.
    • Manages CROs/vendors for assigned post-authorisation studies.
    • Communicates project status and issues and ensure project team goals are met.
    • Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
    • Maintains study timelines and communicates adjustments where necessary.
    • Develops good working relationships with the organisation’s late phase operational team and cross- functional staff internationally as required.

    Key Requirements:

    • The role would require someone with a project management background that has experience working on non-interventional studies (NIS) as well as late phase trials from phase III and IV.
    • Therapeutic area isn’t a specific requirement, but the management of trials in NIS is essential.
    • Working on PASS studies; Investigator lead trials or Compassionate Use Trials would also be a strong advantage
    • Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.

    Skills Alliance are the preffered suppliers for this role. A full job description is available on request. For more information please contact Arturo Maldonado on +44 203 668 3963 or alternatively click APPLY.

    Please note if you do not recieve a response within 72 hours then unfortunately you have be unsuccessful on this ocassion.

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    Skills Alliance are currently partnered with a Global Specialist CNS Pharmaceutical company who is increasing their Manufacturing and as a result searching for an experienced QP to join their team.


    Key Responsibilities

    • Qualified Person as defined in Article 51 of 2001/83/EC
    • Responsible for ensuring that all medicinal products are manufactured to the requirements of EU GMP
    • MHRA and FDA Inspections
    • Lead internal/external quality audits

    Requirements

    • Knowledge of EU GMP, regulations and guidelines.
    • Managing QMS Systems
    • Experience in sterile and non-sterile dosage forms
    • BSc degree in Life Sciences.

    This Qualified Person position is a permanent position and comes with a competitive salary + benefits. 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.

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    Skills Alliance is currently partnered with a leading biopharmaceutical company based in Western Switzerland.

    As an Automation Engineer you will be part of the engineering team responsible for the design, FAT, commissioning, qualification and improvement of the Facility and Process automation systems used to support the production of biopharmaceutical drug substance during the construction and operational phases. You will be part of an exciting & motivated group and will report to the Automation Manager.
    The ideal candidate will have a combined experience of biotech process automation and building management systems.

    Duties and Responsibilities
    • Work closely with various automation, manufacturing, process engineering and IT stakeholders in order to execute the daily activities during Construction, Commissioning and Qualification phase
    • Manage Commissioning & Qualification activities (FAT, SAT, IQ, OQ) related to automation systems
    • Manage Risk analysis and DQ activities related to automation systems
    • Ensure that appropriate project documentation & hand-over are prepared and shared
    • Support the setup and maintenance of the various Facility automation systems, including the Building management systems – HVAC & Black Utilities, Process and Pure Fluids Automation
    • Work independently and supervise the activities of contractors and automation vendors
    • Contribute to the definition of site automation standards. Develop standard operating procedures to ensure the future compliance and management of the automation systems. Work together with the team to prepare the Site Readiness.
    • Once the site becomes operational, handle the automation-related challenges that will affect the day-to-day operation of the new bio-plant and investigate automation issues in GMP environment. Work closely with the Production team.
    • Contribute positively to a strong culture of business integrity and ethics
    • Act within compliance and legal requirements as well as within company guidelines
    • Be open and ready to work in a demanding environment

    Requirements
    • Engineering educational background preferably in Automation, Electrical, Bio or Chemical processing
    • Minimum of 7 years of experience in the biotech engineering/manufacturing environment
    • Demonstrated hands-on experience with various automation systems
    • Experience with DCS/PCS and PLC. Good knowledge of the Rockwell and Siemens platforms. The knowledge of other platforms is an advantage.
    • Knowledge of Virtualization of automated systems
    • Good knowledge of Biotech Process, Utilities and HVAC equipment
    • Knowledge of Single Use process automation is an advantage
    • Understanding of electrical standards
    • Good project management skills and good knowledge of Design, Construction and C&Q activities
    • Fluent in French and English
    • Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP/GAMP practices

    Please get in touch with Irina Bouras + 41 (0) 435 08 28 23 or click apply. We’re looking forward to receiving your application.

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    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

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    A Leading global full service CRO are currently recruiting for a Regulatory Affair Manager or Associate Director (ATMP / GMO) in their London offices.

    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 Oncology, Cardiology, Metabolic diseases and many more.

    Responsibilities:

    Project management focus to facilitate full global regulatory submissions, which will include:

    • Develop and review regulatory submission documents in support of clinical trials with a specific focus in providing Advanced Therapy Medicinal Products (ATMP)/ Genetically Modified Organisms (GMO) advice and dossier compilation;
    • Developing, tracking, compiling, and maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs);
    • Maintaining timelines for full regulatory submissions;
    • Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with UK and European regulations and requirements;
    • Developing scientific and regulatory briefing documents for meetings with the EMA;
    • Interaction with EMA, MHRA, and other regulatory agencies;
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

    Requirements:

    • Bachelor’s degree and demonstrated regulatory affairs experience;
    • Knowledge of Advanced Therapy Medicinal Products (ATMP) is essential with Genetically Modified Organisms (GMO) experience being highly desirable;
    • Experience with EMA and other regulatory agencies is preferred;
    • Strong computer skills, project management skills, and a high attention to detail;
    • Strong communication skills (both written and oral);
    • Must be a team player with a global regulatory mind-set;
    • This position may require supervision of junior level staff.

    Travel: Less than 30%

    This Regulatory Affair Manager or Associate Director (ATMP / GMO) position is a permanent role offering a highly competitive salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 or click APPLY NOW

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    An exciting leading global Biopharmaceutical company are recruiting for a Regulatory Affairs Senior Manager/ Associate Director / Director position based in the Netherlands.

    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:

    • Manage/support the regulatory procedure/document preparation for MAA, post-approval activities (e.g. EU document request, CPP request, legalization, notarization etc.)
    • CRO management on regulatory submission and activities, if assigned
    • Communication with the partners for the timely support, if necessary
    • Review final labelling/artwork components for regulatory submissions/commercial purpose
    • Develop EU specific SOPs and manuals in line with EU regulation/guidance and internal process
    • Provide regulatory information, identifies opportunities, risks and mitigations associated with the regulatory strategies to the Global RA group in SB Headquarter
    • Review relevant regulatory documents to align with regulatory requirements
    • Liaison with EMA and/or local agency (if necessary) as a point of contact if requested
    • Act as a legal representative for clinical trial application in EU
    • Interpret and update the EU regulatory environment and regulatory intelligence

    Requirements:

    • At least 8 years of work experience in regulatory affairs
    • At least 4 years of work experience in EU regulatory affairs
    • Project management experience is preferred
    • A Bachelor’s degree in science or related fields

    This Regulatory Affair Senior Manager/ Associate Director / Director position comes with a highly competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details at 0207 220 6204 or click APPLY NOW

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    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 Anais Croitoru for more details at
    0203 668 3961 or click APPLY NOW

  • UK

    £40000 - £50000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist 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 team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visits

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

    This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

    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.

  • UK

    £60000 - £70000 per annum
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    Quality Manager

    How would you like to influence and shape the quality function for a successful and innovative Pharmaceutical company based in Central London? My client is currently looking for a Quality Manager to oversee the creating and management of all processes and systems to ensure compliance with relevant guidelines within the company.

    This is a great opportunity if you are looking to take your professional career a step further within a company where you can utilise your skillset to its full potential and add value to the role, while building and maintaining relationships with different internal departments.

    Responsibilities:

    • GDP and GMP knowledge
    • Experienced in auditing
    • Knowledge of QMS and SOPs
    • Experienced in training and mentoring junior staff members


    Requirements:

    • At least 5 years’ experience in Quality Management within the pharma industry
    • Line management experience
    • BSc in Pharmaceutical Sciences or equivalent
    • Good analytical and communication skills

    This is a site-based position in Central London. It is initially a 12-month Fixed Term 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.

  • UK

    £55000 - £65000 per annum
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    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.

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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 Oslo, Norway (or London, UK). They will offer a very competitive salary – please get in touch for more details.

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

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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 Oslo, Norway (or London, UK). They will offer a very competitive salary – please get in touch for more details.

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

  • UK

    £50000 - £70000 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, 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). The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £50-60K 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.

  • UK

    £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 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). The role can also be based in Oslo, Norway. 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.

  • UK

    £50000 - £65000 per annum, Bonus + benefits
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    Great opportunity for a Project Manager or Senior Project Manager to join a niche and growing organisation. This is a very varied role, it is permanent, full-time and ideally office-based in Hertfordshire.

    The role is with a niche company who are leaders in the market. The company have seen rapid growth in the past 5 years and will continue to grow and evolve, as such they need someone who is adaptable and can work in a dynamic environment.

    The position is a wide ranging one with responsibility for project work, oversight of clinical teams, client facing responsibility and line management. They require previous clinical project management experience and international experience. Line management would be of benefit.

    This is a permanent and full-time role (may be flex on this). They would prefer people to be office-based in Hertfordshire. 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.

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    Skills Alliance has been exclusively retained by a pioneering, early-stage biotechnology company to hire a Quality Assurance Director. Focused on developing the first-of-its-kind immunotherapies for cancer and other serious diseases, our client is looking to commence their first cell therapy trials in both solid tumor and hematological malignancies.

    The QA Director is a highly visible and influential position with oversight of GMP-related activities, and responsibility for the development of the Quality system. The role reports to the Executive Quality Head and is office-based in Greater London.

    Key Accountabilities:

    • Maintain relevant industry knowledge affecting Quality processes
    • Ensure management of company policies and the quality management system (QMS)
    • Responsible for GMP, GCLP, GDP, HCP, FDA compliance and other associated cell and gene therapy regulatory/ ISO requirements
    • Lead audits, internal and external
    • Review and input into Quality Technical Agreements, validation protocols and reports
    • Provide Quality support for process development associated with product manufacturing
    • Manage controlled documents, SOPs, training and batch manufacturing records
    • Oversee and coordinate corrective and preventative action plans, product complaints and out of specification reporting
    • Demonstratable experience in authoring and management of controlled documents such as SOPs, Batch Manufacturing Records, Product Specification Files etc.

    Education & Qualifications:

    • BSc in a life science or equivalent discipline, advanced degree preferred
    • Experience within a pharmaceutical or biotech company
    • Experience with Quality Assurance experience with ATMP products preferred
    • Experience in developing and implementing a QMS
    • GMP knowledge, specifically ISO-14644 or clean room experience
    • Expertise in GxP regulations preferred; GMP experience mandatory
    • Experience leading audits and pre-license inspection activities.

    This is an opportunity to join an innovative biotech and work in a dynamic, start-up environment. The company seeks engaging and scientifically driven individuals.
    Skills Alliance is exclusively partnered with this innovative company. Please click APPLY or call Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

  • USA

    Competitive Pay + Benefits
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    We are working with a Biopharma company in Seattle who are in search of a Director of Quality Control to add to their team full time, on-site. This is a stable and well-regarded company with a diverse pipeline focused on small molecule and protein therapeutics targeting CNS disorders and oncology. This person will lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP Biologics and small molecule products. Lead and manage QC staff including hiring, developing, evaluating and goal setting. Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination.

    • Biologics/Large Molecule

    • Experience with Analytical Methods under QC

    • Experience with CMO

    • Worked in GMP

    This position is moving quickly, so do not hesitate to apply!

  • USA

    $180,000 - $200,000
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    Location: Richmond, VA
    Remote working available for those within reasonable driving distance (Raleigh-Durham, D.C./Baltimore)

    We are currently partnered with a pioneering addiction treatment company who are focused on expanding the availability of treatment options beyond the clinical setting in the US so that patients can have the flexibility to receive convenient treatment.


    In this role, you would be responsible for setting the global HEOR strategy and value communication in collaboration with R&D, Medical, and Commercial teams. This role will be responsible for all aspects of effective project management, as well as project-specific strategic decisions.

    Requirements:

    • PhD with 2-5 year experience in conducting outcomes research in pharmaceutical industry OR a Master’s degree and at least 5-8 years’ relevant pharmaceutical industry experience
    • Experience in preparing or reviewing materials for HTA and/or drug formulary decision-making
    • Knowledge of health care systems in the U.S. and European HTA bodies
    • Excellent process and project management skills required including the ability to manage a significant volume of projects with exercise of good triage and judgment skills


    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible.

  • USA

    Competitive Salary + Comprehensive Benefits
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    Location: Boston, MA

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for managing all channels of the market access, and establishing relationships with payers in the U.S. This role requires a true strategic thinker, as well as an individual who thrives in a hands-on, growing environment.

    Requirements:

    • Bachelor’s Degree; advanced degree in health management / business is strongly preferred.
    • Minimum of 10-15 years’ experience in US pricing / market access, commercial or finance in the pharmaceutical industry is required.
    • Strong knowledge of the U.S. managed markets including commercial and government payers as well as other channels like Specialty Pharmacies, ACOs, IDNs etc.
    • Can travel domestically and internationally approximately 50% of the time

    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible.

  • USA

    Competitive Salary + Comprehensive Benefits
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    Location: Greater Boston Area

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for executing legislative and advocacy strategies in the US Congress, federal agencies and with other stakeholders This role requires someone who can think strategically while working in a hands-on manner, as well as someone who can engage both internal and external stakeholders.

    Requirements:

    • Bachelor’s Degree; Advanced Degree in healthcare/policy is strongly preferred
    • Minimum 10+ years of relevant experience. Minimum 3-5 years in a government body relevant to healthcare policy
    • Experience with lobbying trade associations, industry groups, and/or working on Capitol Hill or another legislative or administrative body
    • US specialty biologics and biosimilars experience preferred
    • Can travel domestically and internationally approximately 40% of the time

    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible

  • USA

    Competitive Pay + Benefits
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    We are partnered with a Companion Diagnostic Company in Seattle that is transforming care for cancer patients by providing genomic analysis of the disease using non-invasive liquid biopsy methods. Their assay platform has been validated to detect all four major types of genetic alterations that cause cancer! They are seeking an experienced Senior Full Stack Engineer for their team. You’ll be architecting and developing essential software systems that support the IVD development and local R&D projects, as well as facilitate integration with clients and research partners. This is a great opportunity to work for an exciting growing company who will truly make an impact in people’s lives.

    • 5+ years professional experience in software development

    • Experience gathering requirements and user acceptance required

    • React and/or React Native based development

    • Full stack development in a serverless environment using AWS, AWS core services

    • REST API design and development using Node.JS Express

    • Git / GitHub Flow

    • TDD

    • Kanban and/or SCRUM type practice, Jira/Trello

    • Ubuntu / Amazon Linux flavorings

    We are moving quickly on this position so do not hesitate to apply!

  • USA

    $130,000 - $175,000
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    Location: Cambridge,MA

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for managing all regulatory activities in the US. This role requires a true strategic thinker, as well as an individual who thrives in a hands-on, growing environment.

    Requirements:

    • Bachelor’s Degree; advanced degree in Regulatory or related field preferred
    • Minimum of 4 years of direct regulatory experience
    • Project Management experience preferred
    • Understanding of Biosimilars required
    • Can travel domestically and internationally approximately 30% of the time


    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible.

  • USA

    Competitive Salary + Comprehensive Benefits
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    Location: Cambridge, MA

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key support positions to help successfully launch their US business.

    In this role, you would be act as the first point of contact for external stakeholders, would be responsible for creating an engaging office environment and positive interactions with all visitors and staff. This role is a great fit for those with a background in Administration, Human Resources, and Finance.

    Requirements:

    • Minimum 10 years of experience
    • General background and knowledge in accounting procedures, bookkeeping, and budget experience
    • Experience in office management, administration, and great computer skills


    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible.

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    A global pharmaceutical company are currently sourcing for a fully home based Senior Regulatory Project Manager. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability.

    The company focusses in the research of chronic endocrine conditions which are dedicated to developing high quality hormone therapies.

    Responsibilities:

    • Support the Head of Regulatory in devising and developing the Company’s regulatory strategies for all development projects, manufacturing improvements, and the continued registration and licensing for all established products when applicable, including lifecycle management.
    • Act as a point of contact for all regulatory interactions with relevant agencies, including, but not limited to, application for and maintenance of clinical trial/investigational new drug applications, preparing all pre- and post- meeting strategies, and responses and life cycle management.
    • Support the Company at regulatory meetings with the Food and Drug Administration, European Medicines Agency, and other global regulatory agencies as required.
    • Preparation of registration dossiers and submission of Marketing Authorisation Applications (MAAs) / New Drug Applications in line with regulatory authority requirements; and interaction with all licensing partners, and designated vendors such as Contract Research Organisations and others where applicable, to facilitate the submissions of MAAs in their territories.

    Requirements:

    • Education in Bachelors of Biomedical sciences or other relevant discipline.
    • At least 4-10 years’ experience in pharmaceutical regulatory affairs, including with both clinical trial and marketing authorisation applications.
    • Experience working in both project teams and independently, and to timetables/deadlines
    • Excellent communication skills, both oral and written.
    • Experience with electronic Common Technical Document submissions including monitoring publishing activities
    • Experience with both Centralised EU MAA and US FDA NDA and IND regulatory procedures.

    This Regulatory Affair Senior Project Manager is fully home-based permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 for more details or click APPLY NOW

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    Skills Alliance are recruiting on behalf of our global pharmaceutical client, who are currently undertaking a significant shared service transformation programme across their international business. As part of this initiative they are seeking an experienced Business Partner to work with key IT/IS stakeholders during a period of change across their Finance, HR and Procurement systems.


    Job Purpose:

    • Work within the organisation to identify, implement and make effective use of technologies in order to enhance the value of the business for responsible functional area
    • Work with business leaders and the IS Teams to ensure that IT systems are aligned with global business and IS strategy for responsible functional area.
    • Develop and maintain the functional and technology roadmaps to drive the direction of the IT services for the responsible functional area.
    • Manage direct report IS team across regions to deliver IS strategy for responsible functional area
    • Ensure that IT investment is relevant to business requirements, demonstrably beneficial and appropriately leveraged for the global functional area.
    • Act as an internal IT Account Manager for specified business functions or geographies and ensure that the needs of the internal customer are recognised and addressed. Act as an escalation point for senior management.

    Required Experience:

    • Pharmaceutical or similar sector experience with strong customer focus; in multi-disciplinary, matrix and cross-cultural settings.
    • Track-record of leading planning process with excellent organisational and collaboration skills
    • Robust experience in an IT department, including international and multi-national business.
    • Proven in-depth knowledge of design and implementing SAP solutions for Finance & Procurement. Should include exposure to SAP ECC, S/4, Concur, Ariba, BW.
    • Proven experience operating in cross region role working with remote/virtual and cross-cultural teams.
    • Experience of managing Senior non IT stakeholders in Account Management relationships, representing the needs of the business function and the IT department.
    • Experience of strategic planning (Roadmaps) and of aligning IT strategies with business goals.
    • Experience of working through different stages of the systems development life-cycle, including user requirements gathering and blue-printing.
    • Foundation in process management, requirements gathering, analysis technique.
    • Ability to act and react with a customer focus first and foremost and to talk the business language of the customer.
    • Experience of working with a wide variety of Business systems relevant to the function supported. International or Regional/Corporate HQ environment experience preferred but not essential.
    • Able to work flexibly to adapt to a wide range of different types of internal customers
    • Flexibility and mental agility necessary to solve complex problems and develop innovative solutions to business issues
    • Highly numerate and data literate
    • Proven compliance expertise; to understand and comply 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.
    • Strong time management skills with the ability to work with minimal or no supervision.
  • UK

    £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.

  • UK

    £40000 - £50000 per annum
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    Quality Assurance Team Leader

    Would you like to join a successful biopharmaceutical company which focuses on development of T-cell immunotherapy products? My client is currently looking for someone to join their rapidly growing Quality Assurance function as a Quality Specialist/ Quality Team Lead.

    This is a great opportunity for someone who is looking for a more challenging role, within a company where you can utilise your skillset to its full potential and contribute to the further development of the company. As the company expands, you will have the opportunity to progress your career, as well as positively contributing within the progressive new area of cell & gene therapy.

    Responsibilities:

    • Documentation management/ GMP procedures/ PQS templates
    • Materials review and release for use in QC
    • Coordinating change controls and quality exceptions
    • Supporting within audits of GMP contractors


    Requirements:

    • At least 5-8 years’ experience in similar positions
    • Experience working with MHRA and FDA inspections
    • BSc in Pharmaceutical Sciences, Immunology or equivalent
    • Experience working within Biologics, vaccines or ATMPs
    • Enthusiastic and ability to lead others


    This is a site-based position in Hertfordshire. It is initially a 12-month Fixed Term 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.

  • UK

    £40000 - £50000 per annum
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    Quality Assurance Team Leader

    Would you like to join a successful biopharmaceutical company which focuses on development of T-cell immunotherapy products? My client is currently looking for someone to join their rapidly growing Quality Assurance function as a Quality Specialist/ Quality Team Lead.

    This is a great opportunity for someone who is looking for a more challenging role, within a company where you can utilise your skillset to its full potential and contribute to the further development of the company. As the company expands, you will have the opportunity to progress your career, as well as positively contributing within the progressive new area of cell & gene therapy.

    Responsibilities:

    • Documentation management/ GMP procedures/ PQS templates
    • Materials review and release for use in QC
    • Coordinating change controls and quality exceptions
    • Supporting within audits of GMP contractors


    Requirements:

    • At least 5-8 years’ experience in similar positions
    • Experience working with MHRA and FDA inspections
    • BSc in Pharmaceutical Sciences, Immunology or equivalent
    • Experience working within Biologics, vaccines or ATMPs
    • Enthusiastic and ability to lead others


    This is a site-based position in Hertfordshire. It is initially a 12-month Fixed Term 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.

  • UK

    £30000 - £40000 per annum
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    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a QC Analyst position.

    You would be part of a well-established and well-known Pharma organisation, which specialises in the treatment of addiction and critical care. 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:

    • Carrying out analysis of finished products and stability batches

    • Working alongside the technical team

    • Developing analytical methods

    • Working according to GMP standards

    Requirements:

    • 2+ years of relevant experience

    • HPLC, GMP, GLP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal and communication skills

    This Quality Control Analyst 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.

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    Skills Alliance is currently partnered with a leading biopharmaceutical company based in Western Switzerland.

    As an Automation Engineer you will be part of the engineering team responsible for the design, FAT, commissioning, qualification and improvement of the Facility and Process automation systems used to support the production of biopharmaceutical drug substance during the construction and operational phases. You will be part of an exciting & motivated group and will report to the Automation Manager.
    The ideal candidate will have a combined experience of biotech process automation and building management systems.

    Duties and Responsibilities
    • Work closely with various automation, manufacturing, process engineering and IT stakeholders in order to execute the daily activities during Construction, Commissioning and Qualification phase
    • Manage Commissioning & Qualification activities (FAT, SAT, IQ, OQ) related to automation systems
    • Manage Risk analysis and DQ activities related to automation systems
    • Ensure that appropriate project documentation & hand-over are prepared and shared
    • Support the setup and maintenance of the various Facility automation systems, including the Building management systems – HVAC & Black Utilities, Process and Pure Fluids Automation
    • Work independently and supervise the activities of contractors and automation vendors
    • Contribute to the definition of site automation standards. Develop standard operating procedures to ensure the future compliance and management of the automation systems. Work together with the team to prepare the Site Readiness.
    • Once the site becomes operational, handle the automation-related challenges that will affect the day-to-day operation of the new bio-plant and investigate automation issues in GMP environment. Work closely with the Production team.
    • Contribute positively to a strong culture of business integrity and ethics
    • Act within compliance and legal requirements as well as within company guidelines
    • Be open and ready to work in a demanding environment

    Requirements
    • Engineering educational background preferably in Automation, Electrical, Bio or Chemical processing
    • Minimum of 7 years of experience in the biotech engineering/manufacturing environment
    • Demonstrated hands-on experience with various automation systems
    • Experience with DCS/PCS and PLC. Good knowledge of the Rockwell and Siemens platforms. The knowledge of other platforms is an advantage.
    • Knowledge of Virtualization of automated systems
    • Good knowledge of Biotech Process, Utilities and HVAC equipment
    • Knowledge of Single Use process automation is an advantage
    • Understanding of electrical standards
    • Good project management skills and good knowledge of Design, Construction and C&Q activities
    • Fluent in French and English
    • Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP/GAMP practices

    Please get in touch with Irina Bouras + 41 (0) 435 08 28 23 or click apply. We’re looking forward to receiving your application.

  • UK

    £65000 - £75000 per annum, excellent package
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    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
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    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

    £55000 - £65000 per annum, excellent package
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    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

    £35000 - £45000 per annum
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    QA Compliance Specialist

    This is a great opportunity to join a mid-sized leading pharmaceutical company, currently recruiting for a QA Compliance Specialist.

    You would be part of a well-established and well-known Pharma organisation and will get the chance to contribute to the maintenance of the quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate. As the company grows, you will have the opportunity to establish internal and external working relationships, as well as contributing towards reaching the company’s vision within the life science industry.

    Responsibilities:

    • Maintain QMS and PV
    • Implement and perform internal quality audits
    • Prepare GMP documentation such as SOPs
    • Conducting training sessions on QA systems

    Requirements:

    • Excellent communication skills
    • Ability to work with other individuals from different cultures
    • Experience of Electronic Document Management Systems
    • Ability to leant and adapt quickly

    This is an office-based position based in Berkshire area. It is a 12 months fixed term 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.

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    Would you be interested in working with a leading global CRO company as a Regulatory Affairs Officer 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.
    • Participates in the quality control (QC) steps and ensures each submission has been checked by an appropriately qualified member of the companies regulatory group prior to submission.
    • Ensures all queries raised by Ethics Committees (ECs) and regulatory authorities (RAs) are addressed within required timeframes, including management of applicable negotiations.
    • Maintains metrics on a monthly basis of all regulatory submissions made by the company.
    • Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
    • 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:

    • Science graduate with at least 4 years of industry experience in a regulated environment with CT RA and EC submissions in 2 or more countries.
    • Expert knowledge of ICH-GCP and local regulatory agency and ethics committee regulations and requirements
    • The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities

    This Regulatory Affair Officer position comes with a competitive basic 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

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    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

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    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.
      • Serves as key regulatory liaison for multi-continental project on behalf of the company (Oncology (Europe). Liaison with other departments within the company, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
      • 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:

    • Science graduate with at least 6-12 months of industry experience in a regulatory environment.
    • Completion of The company’s Oncology training programme
    • Detailed Knowledge of ICH-GCP and local regulatory agency and ethics Committee regulations and requirements
    • The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities

    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

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    A leading pioneering software medical device company are currently on the market for a VP of Regulatory Affairs. With the company within its pivotal moment in its history and following the launch of a new program, the VP would overlook and be accountable for the overall Regulatory Affairs function.

    Responsibilities:

    • Provide strategic vision, expertise and leadership in the development of products and regulatory approval in the UK, Europe, US and then worldwide.
    • Responsibility for the company’s compliance with regulatory agencies and all applicable standards worldwide
    • Input as needed into the clinical studies required for Regulatory Approvals. Conversant in the key aspects and able to work with in-house and external experts in medical statistics, clinical study design, and data analysis.
    • Provide training and interpretation of FDA and other regulatory issues across the company more generally
    • Be responsible for the review and approval of promotional, advertising, and labelling items as and where necessary
    • Lead the Compliance to the Medical Device Directive (MDD) in the EU, FDA, and other regulatory agencies.

    Requirements:

    • Demonstrate significant regulatory experience and strategic thinking in novel situations.
    • Proven experience of achieving regulatory approvals for Software as a Medical device in the EU and USA.
    • A commercial focus in the application of regulatory requirements.
    • Outstanding communication skills, both verbal and written, and the ability to interface effectively with software engineering, operations, sales and marketing, and a wide range of other stakeholders
    • Bachelor’s or higher degree, preferably in life sciences, engineering, or business desirable

    The VP of Regulatory Affair is a permanent role offering a competitive salary and benefit package located in Cambridge.

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

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    A growing global Biopharmaceutical company in Oxford are currently on the hunt for a Global Regulatory Affair Senior Manager with speciality in the ROW territories located in their Oxford offices.

    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 areas.

    Responsibilities:

    • Proven experience in regulatory affairs with particular focus on initiating and managing new ROW registrations and life-cycle maintenance activities (e.g. Variation applications including new indications, Renewals, PSUR submissions, Notifications, MA transfers, MA cancellations)
    • Act as contact point/knowledge base for scientific & technical aspects of Module 1 documents and associated regulatory activities
    • Ensure compliance with product post-marketing approval requirements
    • Timely filing of complete, high quality regulatory submissions; prompt, complete and accurate management of responses to Health Authority questions and effective communication of approvals
    • Ensure that all submissions comply with the current regulatory guidelines and legislation at all times. Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
    • Ensure 100% accurate and complete archiving of all submissions, approvals and regulatory agency correspondence performed in ROW markets. Ensuring that regulatory document management system contains the most current and accurate information

    Requirements:

    • Minimum of 7 years’ experience in the pharmaceutical industry, with minimum of 5 years direct experience in ROW registration activities
    • Planning & management of all allocated projects and ensuring timely delivery of these projects
    • Collaborate with cross-functional team to develop and implement regulatory strategies based on organisational priorities and resource availability
    • Working knowledge of regulatory requirements and cultural differences for various country registrations and maintenance activities (e.g. local regulatory partners, local distributors and MA holders, regulatory agencies)
    • Ability to work cross-functionally and in collaboration with key internal stakeholders/customers (e.g. commercial, technical, quality, medical, supply chain etc.)
    • In addition to working in cross-functional teams, must also be able to work successfully as an individual contributor, with a high level of professionalism.

    This Global Regulatory Affair Senior Manager is a permanent role offering a highly competitive salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 or click APPLY NOW

  • UK

    £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a European-based 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:

    • Coordinate qualification and routine requalification in the sterile processes
    • Knowledge of sterile and aseptic technical processes
    • Developing analytical methods
    • Implementing CAPAs

    Requirements:

    • 3+ years of experience in leading investigations
    • HPLC, GMP, GLP knowledge
    • 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 Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • UK

    COMPETITIVE
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    I’m currently partnered with a Biotech company in Scotland who are looking for a QA Specialist to join their team and work within the area of ATMPs. This is an excellent opportunity for someone who is looking for the next step in their career and a new challenge in the ever-growing Biotech industry.

    Responsibilities include:

    • Creating and revising batch records, SOPs and logbooks
    • Document Control
    • QMS Management
    • Internal and External Audits
    • Working to GMP regulations

    If you are interested in learning more about this opportunity, please submit your CV for a confidential discussion.

  • UK

    £55000 - £65000 per annum, excellent package
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    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.

  • Competitive Salary and benefits package
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    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.