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  • €55000 - €80000 per annum
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    A Specialist French Manufacturing company are recruiting for a Regulatory Affairs Manager – Medical Devices position to be based in the East of France.

    this is an opportunity to join a fast growing company that produce high quality products for use in the field of Anti-ageing. As they grow there will be excellent opportunities for progression within the company.

    you would be responsible for Managing a small team of trained Regulatory Staff, Explaining regulation of Medical Devices, Overseeing submissions and variations and Reporting to Head of Regulatory.

    This Regulatory Affairs Medical Devices role is an office-based position in East of France with flexibility.
    It is a permanent role offering around €55,000 – €80,000 + bonus + benefits.

    Skills Alliance are the preferred supplier for this role. please contact John DaCosta for more details at 0207 220 6233.

  • UK

    £60000 - £75000 per annum, + Benefits
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    Senior Manager/AD CMC – Regulatory

    A very exciting opportunity to join an innovative pharma company that is recruiting for a Senior Manager/Associate Director CMC – Regulatory position.

    This is an opportunity that allows for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for maintaining measures to keep development projects away from regulatory risks and, establish CMC regulatory strategy for projects/products. Lead preparation of regulatory communication documents and materials. Attend internal Health Authority regulatory meetings to solve issues on CMC/Quality of the development projects. As a Senior Manager/Associate Director you will be leading the preparation of submission dossiers, including authoring QOS. As well as estimate changes proposed by QA/manufacturing and take necessary regulatory measures. Strong communication with business partners/affiliates in new markets to obtain market launch is required. As well as, evaluate CMC regulatory situations and propose solutions to make CMC activities more productive.

    They require a working knowledge of the development and / or manufacture of small molecules and biologics compounds. Knowledge of the analytical aspects relevant to small molecules and biologics including specification setting. Experience with regulatory agencies, submissions and preparation of briefing documents. A Bachelor’s Degree (or equivalent with experience) in a scientific or technical discipline; MSc Ph.D, MBA is preferred.

    This Senior Manager/Associate Director CMC – Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    Reference #IOSMADCMC

  • USA

    $120000 - $140000 per annum
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    This is an excellent opportunity to join an industry leading global pharmaceutical services and consulting agency offering a vast amount of cutting-edge services to the pharmaceutical industry in the Greater New York City area.

    As the Data Manager/Programmer, you will take on a data-management focused role where you will be supporting clinical outcome databases for model-based meta-analyses. You will serve in a critical role becoming part of an exciting new project and play a crucial part in the organizations continued success.

    You will have a unique opportunity to write and develop high quality programs like R and SAS to help facilitate PopPK datasets. Conducting quality control and quality assurance on different datasets, reports, and analyses will be an important aspect of this role.

    You must have a minimum of a master’s degree in Statistics, Mathematics, or another Scientific discipline and 3-5 years of experience in data management and high-quality programming. A PhD and a background in writing SAS/R would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success within Pharmacometrics. This is the right time to be joining this rapidly growing and dynamic team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

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    Skills Alliance is partnered with an exceptional biotech in the north east that is looking to bring on board a VP of Clinical Development. My client is an oncology focused biotech that is rapidly growing in the Tri-State area and they are looking to bring onboard another pillar of the company.

    The VP must be an M.D. that excels in small teams. This individual will be reporting into the CEO and will be pivotal for the development of their assets. The ideal candidate would have spent most of their career in the oncology space and been exposed across all phases of studies. The assets that the VP would cover will be primarily late phase work, which enables one to have the possiblity to bring a product to market soon. The Vice President will also have the ability to shape the culture and the team underneath them as they are working hand in hand with the CEO in this role. Great opportunity for mentoring junior staff and having leadership responsibilities.

    Along with the very interesting nature of this role, the compensation package can be very lucrative as well.

    If you were interested in learning more about the opportunity, please submit a copy of CV for consideration.

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    This is an excellent opportunity to join one of the most exciting healthcare marketing agencies in New York area and the chance to work with the top pharmaceutical organizations.

    As the Scientific Communication director, you will become the subject matter expert in the publication space. The successful applicant will have the chance to have a leadership role and have an influential position in the organization.

    The applicant will have a rare opportunity to ensure scientific materials produced are of high quality and supported by current scientific thinking. In this role, you will ultimately maintain and build the scientific reputation of the company. You will be responsible for managing multiple accounts from a scientific perspective including publication plans and advisory boards. You will also engage in client interactions and meetings to demonstrate content. You will also write abstracts and manuscript outlines while gaining experience in managing freelance writers to projects.

    You must have a minimum of an advanced degree in biomedical sciences (PhD, MD or PharmD). Also, a minimum of 5 years of academic, pharmaceutical industry or agency experience. A background in multiple therapeutic areas and a strong personality would be looked at favorably.

    The company is one of the leading healthcare focused marketing and consulting agency. They are currently merging and creating more opportunity for growth and expansion. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at alex.f.a4lgdx1gr3mz@skillsalliance.aptrack.co

  • USA

    $110000 - $150000 per annum
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    This is an excellent opportunity to join an industry leading global pharmaceutical services and consulting agency offering a vast amount of cutting-edge services to the pharmaceutical industry in the Greater New York City area.

    As the Director of Business Development, you will take on an imperative role of driving sales and business development for the Market Access and HEOR services across the US. You will have a unique opportunity to assist in building the business for a top model-informed drug development and real-world evidence solutions company.

    The main responsibility for this role will be to ensure designated accounts’ sales goals are reached and sales targets are being hit. Initiating client contacts, generating new leads and following-up on existing leads will be a crucial aspect of building a book of business in order to meet those targets. The ideal candidates will be aggressive in pursuing new clients to enhance the Real-World Evidence solutions clientele base within the pharmaceutical market.

    You must have a minimum of a Bachelor’s degree in Health Science, Health Economics, or another Scientific discipline and at least 4 years of experience of consultative selling within the pharmaceutical industry. An advanced business degree and experience selling market access services would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success within Pharmaceutical services, specifically real-world evidence solutions and Market Access. This is the right time to be joining this rapidly growing and dynamic team!

  • USA

    $165000 - $185000 per annum
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    This is an excellent opportunity to join one of the most exciting pharmaceutical companies in the Greater Boston area that just launched their first product and are exponentially growing their team within the Southern territory.

    As the MSL, you will initially take on an operationally focused role managing and implementing the foundation of a ground-breaking product launch. The company has a robust pipeline for future assets which includes a gene therapy product, giving you the chance to diversify the products you oversee. As the number of products increase and develop within the company, you will have the chance for rapid career progression within the team.

    As the MSL you will have the opportunity to interface and liaise with physicians and KOLs within the territory for this leading rheumatoid therapeutic. This company is still in launch mode which gives you the opportunity to really influence the success of the company with your contributions.

    You must have a minimum of a PhD, MD or PharmD and a minimum of 3-5 years of MSL experience. You must have a background in pain, rheumatology, or orthopedics.

    The company is one of the most unique in the industry with a proven track record of success with the approval of their first product. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8343 or alex.f.a4lgdx1gr3n5@skillsalliance.aptrack.co

  • UK

    £40000 - £55000 per annum
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    An independent Health Economics consultancy is offering a Consultant position with flexible working in London.

    This is an opportunity to join a friendly and professional company that is specialising in delivering health economic solutions to support access to new health technologies. As part of this growing company you can make a difference and develop with them. They build clear Health Economic models from concept to conclusion, participate in health technology assessments (HTA) and help with complex reimbursement procedures.

    You would be responsible for helping the modeling team to deliver projects around evidence generation, cost-effectiveness models and budget impact analysis, training junior members on HTA submissions and working on real world data.

    The Consultant role is office based mostly with couple of days remote work opportunity. This permanent position is for hands-on individuals who are passionate about Health Economics and want to earn well. The role is offering above the average, all depending on your experience.

    Skills Alliance are the preferred supplier for this role. Please contact Ottilia Molnar for more details on +44/2072206224.

  • USA

    $40000 - $50000 per annum
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    Fast-Growing Medical Technology Company with goals in reducing the time and cost of volunteer recruitment for clinical trials through a science-validated, ground breaking online test for Brain Health.
    As a part of the Engagement Team you will assist in promoting their services (brain health workshops, assessments, etc).

    This is a remote position where you get to work from home and travel to your designated territory where you will visit a few facilities a day.

    Ideal candidates will come with the following:
    (6 month + of experience minimum)
    • Experience working with the elderly population.
    • Experience with Patient recruitment
    • Experience with Neuro-degenerative Diseases (Alzheimer’s, Parkinson’s, dementia, etc)
    • Great friendly personality who shine with radiating energy

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    I am urgently seeking Medical Writers, specialized in regulatory submissions in the BioPharmaceutical Industry for an opportunity working with a company that values a diverse and supportive environment for their employees, while continuing to deliver new innovative therapies to the market that will help improve the lives of individuals with cancer. Must live in Boston or surrounding area or be willing to relocate to Boston, Massachusetts, as this is a permanent, Full-Time position requiring on-site work.

    Reporting into the VP of Medical Writing, the essential functions of the role include but are not limited to preparing, editing and review of IND’s, NDA’s, CSR’s, protocols, consent forms, IB’s, SOP’s, document support, and quality review.

    Ideal Candidate must have at least 5 years of Medical Writing experience, Regulatory Submissions experience (IND, NDA, etc), and Biotech or Pharmaceutical Industry experience as a Medical Writer.

  • £65000 - £75000 per annum
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    Are you a Qualified Person looking for an opportunity to work within a well known organisation?

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

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

    The main function of this role will be:

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

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

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

    If this role looks to be of interest and you would like to discuss in further detail, please contact me on: 0207 220 6218.

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

  • £140000 - £150000 per annum, Benefits
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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • €70000 - €80000 per annum
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    A leading international company that creates superior, exclusively branded products marketed through independent representatives are looking for a Director of Product Development.

    This is an opportunity to join a world-class company that are currently expanding within Europe and just launched their new European office in Dublin, Ireland. As they expand there will be excellent opportunities for progression and development.

    You will be responsible for assisting in new product development. In addition, reviewing and developing improvements for existing product. Training Representatives about product ingredients and the benefits of using the company products. They require an experienced Director of Product Development who has good presentation skills.

    This Director of Product Development role is an office-based position in Dublin, Ireland with flexibility and travel opportunities. It is a permanent role with a negotiable salary starting from €70,000 + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact John DaCosta for more details on +44 207 220 6233.

  • €45000 - €55000 per annum
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    A leading international company that creates superior, exclusively branded products marketed through independent representatives are looking for a Product Development Project Manager.

    This is an opportunity to join a world-class company that are currently expanding within Europe and just launched their new European office in Dublin, Ireland. As they expand there will be excellent opportunities for progression and development.

    You will be responsible for managing information of all ongoing projects that Product Development is working on. Work directly with our Director of Product Development and Skin Care Specialist to track information and be able to present information to our Chief Product Officer on all Product Development Projects. They require an experienced Product Development Project Manager who has good presentation skills.

    This Product Development Project Manager role is an office-based position in Dublin, Ireland with flexibility. It is a permanent role with a negotiable salary starting from €45,000 + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact John DaCosta for more details on +44 207 220 6233.

  • €40000 - €50000 per annum
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    A leading international company that creates superior, exclusively branded products marketed through independent representatives are looking for a Skin Care Specialist.

    This is an opportunity to join a world-class company that are currently expanding within Europe and just launched their new European office in Dublin, Ireland. As they expand there will be excellent opportunities for progression and development.

    You will be responsible for assisting in new product development specifically for Skin Care. In addition, you will be reviewing and developing improvements for existing product. Will train Representatives about product ingredients and the benefits of using products. They require an experienced Skin Care Specialist who has experience in the cosmetic industry.

    This Skin Care Specialist role is an office-based position in Dublin, Ireland with flexibility. It is a permanent role with a negotiable salary starting from €40,000 + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact John DaCosta for more details on +44 207 220 6233.

  • €85000 - €100000 per annum
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    Our client, a global leader in immunohematology, is currently seeking a Process Engineer with an affinity for continuous improvement using LEAN methodologies. The incumbent will implement and perform projects using the LEAN Six Sigma methodology. Additionally, the chosen candidate will help develop qualification and validation programs on the site and lead workshops (KAIZEN / 5S).

    To qualify for this position, you need a degree in engineering or equivalent and have at least 5 years of experience in the validation and qualification of processes and equipment in the pharmaceutical or medical device industry. A certification in Lean (Green/Black Belt) is not required but a great asset. To integrate their team, you must speak French or German fluently as well as English.

    If you wish to find out more, please contact Khephren Mongongu +41 43 508 29 16 or click apply. All applications and discussions are treated confidentially.

  • UK

    £40000 - £60000 per annum, benefits
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    A cutting-edge Patient Recruitment company is seeking an experience Patient Recruitment Manager to join their growing team.

    This is a unique opportunity to move into a highly visible role within the UK whilst working closely with senior management. You will be responsible for overseeing patient enrolment for various research sites whilst leading a team of ambitious employees.

    Responsibilities:

    • Oversee patient enrolment and recruitment strategies
    • Work closely with research sites in order to hit enrolment targets
    • Oversee patient recruitment specialists and coordinators

    Experienced Required:

    • 2 years patient recruitment experience (Preferably at manager level)
    • Experience working with seniors a bonus
    • A track record of hitting and exceeding enrolment targets

    For more info please contact Troy Neenan on 02072206237 or click apply.

  • €110000 - €130000 per annum
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    Our client a global leader in the life science and applied chemical markets is looking for an experimented Support Manager to strengthen their service and support team

    You will manage a team of highly qualified engineers and provide leadership planning and management in order to meet customer needs and business objectives

    Responsibilities

    Lead and motivate a team of Field Service Engineers

    Manage hiring development workload and work efficiency of direct reports to achieve maximum productivity and optimize support resources

    Manage financial targets and drive order and revenue growth programs

    Demonstrate clear leadership and support of the Support strategy and products

    Understand customer needs and assure development of services and the provision of effective delivery processes

    Work closely with the Business Team Managers

    Negotiation and effective communication skills

    Knowledge of analytical industry required

    To qualify for this position you need a Bachelors or Master Degree or University Degree or equivalent plus directly relevant experience as a manager supervisor and or individual contributor
    Must have experience leading cross functional or cross geography projects

    Strong Leadership and management skills
    Excellent English and French skills both verbal and written

  • €60000 - €70000 per annum
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    Our client a leading international medical device company specializing with the operating room equipment is looking for their next Clinical Nurse for the Romandie part of Switzerland

    The ideal candidate has at least 4 years experience in the operating room as a nurse or chief of operating room

    Main activities

    To conduct product trials tests in operating rooms

    To demonstrate to a client the benefits of the products through sales presentations product trials etc

    To implement various product lines for the customers

    To identify and develop new sales opportunities for your geographic area and also promote the new product lines
    For this you establish and maintain excellent relationships with existing customers and prospects with the permanent concern to achieve sales targets

    Secondary Support Responsibilities

    Promote the image of the company to customers

    Qualifications

    Qualified nurse or qualified operating nurse with a technical experience acquired in the medical field

    Excellent communication and presentation skills

    Ability to demonstrate sales aptitude

    Ability to absorb and convey information

    Good time management skills and the ability to prioritize tasks

    Ability to work as part of a team and on own initiative

    Excellent English and French skills both verbal and written

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    Senior Manager Regulatory Affairs CMC

    A leading Pharma company specialising in both drugs and medical devices is recruiting for a Senior Manager Regulatory Affairs in Mannheim, Munich or Friedrichsdorf, Germany.

    This is an opportunity to be part of a dynamic and growing Pharma company with a global presence. As they expand there will be excellent scope for progression and development. Providing you with a competitive salary and a dynamic place to work based on trust, self-confidence, and achievement.

    As Senior Manager CMC your role will be to compile and check documentation of module 3, QOS, IMPD, ASMF etc for national and international markets. You will prepare Gap Analysis of pharmaceutical quality dossiers with due diligence. Communicate with authorities as well as supervise the development of projects and marketing authorisation procedures. As Senior Manager CMC you are to compile and review PQRs, coordinate and perform CEP as well as life cycle management processes.

    A diversified and challenging position with cooperating partnership and leeway will be offered. As well as flexible working hours based on trust with continuous development opportunities and a competitive salary provided.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRAPLG

  • £140000 - £150000 per annum, Benefits
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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

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    Senior Manager Regulatory Affairs CMC

    A leading Pharma company specialising in both drugs and medical devices is recruiting for a Senior Manager Regulatory Affairs in Mannheim, Munich or Friedrichsdorf, Germany.

    This is an opportunity to be part of a dynamic and growing Pharma company with a global presence. As they expand there will be excellent scope for progression and development. Providing you with a competitive salary and a dynamic place to work based on trust, self-confidence, and achievement.

    As Senior Manager CMC your role will be to compile and check documentation of module 3, QOS, IMPD, ASMF etc for national and international markets. You will prepare Gap Analysis of pharmaceutical quality dossiers with due diligence. Communicate with authorities as well as supervise the development of projects and marketing authorisation procedures. As Senior Manager CMC you are to compile and review PQRs, coordinate and perform CEP as well as life cycle management processes.

    A diversified and challenging position with cooperating partnership and leeway will be offered. As well as flexible working hours based on trust with continuous development opportunities and a competitive salary provided.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRAPLG

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    Senior Manager Regulatory Affairs (f/m/d)

    A leading pharma company specialising in all aspects of drugs and medical devices is recruiting for a Senior Manager Regulatory Affairs in Mannheim, Germany.

    This is an opportunity to be part of a dynamic and growing pharma company with a global presence. As they expand there will be excellent scope for progression and development. Providing you with a competitive salary and a dynamic place to work based on trust, self-confidence, and achievement.

    Your role will be to plan and implement approval procedures in the EU, (MRP, DCP, CP and national procedures) emerging markets as well as, of life cycle management which include variations, renewals, MAH, transfer etc. worldwide. You will be communicating with the project team, local partners and authorities in international context. As Senior Regulatory Affairs Manager you will have the opportunity for the revision of approval documents and text management including labelling management.

    They will require you to have successfully completed at least 3 years of professional experience in marketing authorisation with a focus on the EU or non – EU marketing authorisation procedure. You will ideally have expressed launch management (DE), labelling management and CTA. They require you to have sound knowledge of current pharmaceutical and regulatory requirements with a degree in pharmacy, medicine or other life sciences.

    A diversified and challenging position with cooperating partnership and leeway will be offered. As well as flexible working hours based on trust with continuous development opportunities and a competitive salary provided.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRAPLG

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    Principle Regulatory Affairs Executive

    A leading European pharmaceutical company with an established presence in all major European markets is recruiting for an office based Principal Regulatory Affairs Executive to join their team in Greater London.

    This fantastic position sees you as responsible for the documentation of all regulatory submissions, primarily CMC variations with minimum supervision. Providing you with a competitive salary and a dynamic place to work based on trust, self-confidence, and achievement.

    Under minimum supervision, you will be preparing and maintaining product labelling for appropriate markets in cooperation with local regulatory and commercial contacts. As a Principle Regulatory Affairs Executive, you will anticipate and resolve complex issues and actively participate as regulatory resource in cross-functional project teams. The Principal Regulatory Affairs Executive will guide and manage direct reports as well as prepare and review submissions within agreed timelines. You will also provide input into the budgeting process for prospective regulatory submissions. Maintaining paper and electronic filing systems for assigned products/Countries while following record retention procedures.

    They will require you to work under minimum supervision to prepare and submit high-quality documentation for all regulatory submissions following best practice standards. Including the preparation, when applicable of ASMFs and submission of CEP applications. You will be experienced in liaising with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met. Experience in communicating with authorities to expedite the approval of submissions is also a necessary requirement.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSPRAE

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

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    Drug Safety Specialist

    A leading pharma company are recruiting for a Drug Safety Specialist in Greater London.

    This is a fantastic opportunity that allows for collaborative input making a real difference in the lives of patients and the life sciences. Providing a competitive salary.

    As Drug Safety Specialist your responsibilities are to ensure that all ICSRs relating to EMEA products are processed by EEL PV, from receipt to submission, in accordance with timelines and standards specified. ICSRs will be submitted to regulatory agencies, distributed affiliate offices and partners in accordance with timelines. As Drug Safety Specialist you will be responsible for downloading ICSRs from the Eudravigilance web portal converting them into R2 format. Accurate input of source data onto global safety database (ARISg) and perform QC checks of ICSR. You will be required to participate in training and provide support to the ICSR team lead in production of monthly ICSR compliance. As Drug safety specialist you will also support the EEL PV safety evaluation team in preparation and quality control of ICSR.

    They require you to have knowledge of the equipment ARISg, agXchange, IRT, Business objects Microsoft Word, E2B BRIDGE, eRoom. You must have good knowledge of global safety databases, data entry practices, medical coding dictionaries and graduate level education (life sciences, pharmacy or nursing degrees would be an advantage). Previous experience in pharmacovigilance such as Business Objects is desirable.

    This Drug Safety Specialist opportunity is a fixed term 6-month contract that will broaden experience and knowledge. It is an office-based position with flexibility and a competitive salary.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMADCMC

  • UK

    £60000 - £75000 per annum, + Benefits
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    Senior Manager/AD CMC – Regulatory

    A very exciting opportunity to join an innovative pharma company that is recruiting for a Senior Manager/Associate Director CMC – Regulatory position.

    This is an opportunity that allows for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for maintaining measures to keep development projects away from regulatory risks and, establish CMC regulatory strategy for projects/products. Lead preparation of regulatory communication documents and materials. Attend internal Health Authority regulatory meetings to solve issues on CMC/Quality of the development projects. As a Senior Manager/Associate Director you will be leading the preparation of submission dossiers, including authoring QOS. As well as estimate changes proposed by QA/manufacturing and take necessary regulatory measures. Strong communication with business partners/affiliates in new markets to obtain market launch is required. As well as, evaluate CMC regulatory situations and propose solutions to make CMC activities more productive.

    They require a working knowledge of the development and / or manufacture of small molecules and biologics compounds. Knowledge of the analytical aspects relevant to small molecules and biologics including specification setting. Experience with regulatory agencies, submissions and preparation of briefing documents. A Bachelor’s Degree (or equivalent with experience) in a scientific or technical discipline; MSc Ph.D, MBA is preferred.

    This Senior Manager/Associate Director CMC – Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    Reference #IOSMADCMC

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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs, NBG in the Greater London area.

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    The senior manager will have important input into global regulatory strategy, including the design of clinical development programmes. Submission work will include leading the preparation of orphan drug applications, PIPs and clinical trial applications. As a senior manager you will be responsible for applications through to approval and post approval. Working closely with US based global regulatory lead and project team. Regulatory strategy development, implementation, the resolution of regulatory risks is required. Submissions of CTA/MAA as well as life cycle management and interfacing with regulatory authorities will all be part of this diverse and exciting role. The senior manager will have the opportunity to be at the helm of their financial, matrix and team management.

    They require experience with EU regulatory processes and environment, including clinical trials, scientific advice, PIPs and orphan drugs. Strategic experience and strong strategic cognitive ability. Strong organisational and problem-solving skills. Experience in neuroscience therapy and a BSc/MSc is desired.

    This Senior Manager, Regulatory Affairs, NBG role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRANBG

  • £50000 - £60000 per annum, + Benefits
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    Senior Manager, Regulatory Affairs, OBG

    A leading pharma company is recruiting for a Senior Manager, Regulatory Affairs /Senior Director in Greater London.

    This fantastic opportunity allows you to be responsible for one of the company’s key assets of life cycle maintenance and provide strategic support for the activities. Providing you with an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You would be responsible for developing and implementing regulatory strategy for your own functional area and region. Lead the resolution of regulatory risks by identifying, escalating and monitoring issues. Submissions of CTA/MAA and organise resources and processes across multiple teams. Deliver objectives within agreed timeframes and contribute to the planning, execution, and assessment of product life cycle management. Interacting with authorities autonomously and ensure contractors, consultants and vendors complete assignments successfully. Your skills will be required for resource, financial, matrix and team management.

    The require experience in liaising with regulatory authorities, life cycle management for CP, including Type 1 and Type 2 license variations, line extensions, negotiation, labelling and regulatory authorities. Experience in the oncology therapeutic areas with an education in BS/MS being preferred.

    This Senior Manager/Associate Director CMC – Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRAOBG

  • €50000 - €65000 per annum
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    We are recruiting on behalf of a leading laboratory and pharmaceutical equipment provider a Business Development Manager Bioprocess to strengthen the team in Belgium

    He She is in contact with R D PD Centers and QC Labs of the Key Account

    He She has a comprehensive knowledge of

    Customer pipeline process flow chart for the key molecules tech transfer
    Bioprocess Portfolio

    Implements procedures and methods that add value to the customer and generate additional business opportunities

    Contributes to successful completion of international and local at PD Centers negotiations
    projects and contracts with the customer ensuring that customer business
    needs are met

    Establish local relationships with customer key company representatives especially in the R D and Process Developments Groups

    Accelerates introduction of newly launched products services and solutions at the accounts and provides structured and regular market and application feedback to internal stakeholders

    Coordinates Application Specialists for the assigned PD Centers

    In order to qualify for this position a Bachelors degree is required engineer or scientist in the Biopharm industry preferred
    Minimum 2 years of successful experience in Process Development Fermentation
    UF DF Purification Process Manufacturing support or in a similar function
    Experience with the development of scale up and scale down models validations
    investigations process optimizations and troubleshooting
    Relevant technical knowledge and extensive industry knowledge PharmaBiotech that
    allows to successfully compete in our target markets
    Additional experience in cGLP manufacturing
    Managerial agility that allows to lead and implement strategy and initiatives in highly
    regulated and competitive global markets
    Ability to work independently and be selfdriven highly motivated and patient with
    continual attention to business retention and expansion
    Ability to manage complex issues using innovation and processes
    Skilled in developing action plans and programs to position Divisional or corporate
    priorities
    Excellent communication skills at all levels of the organization internally and
    externally
    Fluid in English French and Flemish Dutch

  • UK

    £25000 - £30000 per annum, benefits
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    I am partnered with an innovative and cutting-edge Patient Recruitment Company focussed in Alzheimer’s who are looking for a Patient Recruitment Specialist for their growing team.

    This is a unique opportunity to for someone who enjoys working closely with patients and is keen to progress their career in a dynamic environment. You will be responsible for recruiting patients onto a variety of different studies whilst working closely with community leaders and research sites.

    Required experience:

    • 1 year plus experience working within clinical trials and patient recruitment
    • Strong communication and interpersonal skills
    • Experience working with seniors within Alzheimer’s/Dementia desirable
    • Good knowledge of Plymouth and surrounding areas


    For more information please contact Troy Neenan on 02072206237 or click apply.

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    Skills Alliance are currently partnered with an American based CRO that is looking to expand their operations across several countries within Europe. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team in the following locations: France, Belgium, Germany and Austria starting the Second Quarter of 2019.

    If you are a Freelance Clinical Research Associate with +5 years monitoring and study Start Up experience and are looking for a new contract in the coming months then feel free to get in touch.

    JOB TITLE

    Freelance Clinical Research Associate

    1.0FTE

    12 months

    LOCATION

    France, Belgium, Germany and Austria

    Home based

    RATE

    Competitive rate + Expenses

    ROLE

    Working directly with the sponsor you will implement and monitor trials across a wide spectrum of therapeutic areas, ensuring that sponsor and investigator obligations are met, and overseeing compliance with ICH GCP and European regulatory requirements. You will carry out monitoring visits including initiation, routine monitoring and close out.

    REQUIREMENTS

    +5 years monitoring experience

    Experience working in a Medical Devices or Pharma Company

    Previous experience in Oncology or Cardiovascular

    Phase II to IV experience is essential

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    Skills Alliance are currently partnered with an American based CRO that is looking to expand their operations across several countries within Europe. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team in the following locations: France, Belgium, Germany and Austria starting the Second Quarter of 2019.

    If you are a Freelance Clinical Research Associate with +5 years monitoring and study Start Up experience and are looking for a new contract in the coming months then feel free to get in touch.

    JOB TITLE

    Freelance Clinical Research Associate

    1.0 FTE

    12 months

    LOCATION

    France, Belgium, Germany and Austria

    Home based

    RATE

    Competitive rate + Expenses

    ROLE

    Working directly with the sponsor you will implement and monitor trials across a wide spectrum of therapeutic areas, ensuring that sponsor and investigator obligations are met, and overseeing compliance with ICH GCP and European regulatory requirements. You will carry out monitoring visits including initiation, routine monitoring and close out.

    REQUIREMENTS

    +5 years monitoring experience

    Experience working in a Medical Devices or Pharma Company

    Previous experience in Oncology or Cardiovascular

    Phase II to IV experience is essential

  • Apply

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    Share

    Skills Alliance are currently partnered with an American based CRO that is looking to expand their operations across several countries within Europe. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team in the following locations: France, Belgium, Germany and Austria starting the Second Quarter of 2019.

    If you are a Freelance Clinical Research Associate with +5 years monitoring and study Start Up experience and are looking for a new contract in the coming months then feel free to get in touch.

    JOB TITLE

    Freelance Clinical Research Associate

    1.0 FTE

    12 months

    LOCATION

    France, Belgium, Germany and Austria

    Home based

    RATE

    Competitive rate + Expenses

    ROLE

    Working directly with the sponsor you will implement and monitor trials across a wide spectrum of therapeutic areas, ensuring that sponsor and investigator obligations are met, and overseeing compliance with ICH GCP and European regulatory requirements. You will carry out monitoring visits including initiation, routine monitoring and close out.

    REQUIREMENTS

    +5 years monitoring experience

    Experience working in a Medical Devices or Pharma Company

    Previous experience in Oncology or Cardiovascular

    Phase II to IV experience is essential

  • Apply

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


    Share

    Skills Alliance are currently partnered with an American based CRO that is looking to expand their operations across several countries within Europe. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team in the following locations: France, Belgium, Germany and Austria starting the Second Quarter of 2019.

    If you are a Freelance Clinical Research Associate with +5 years monitoring and study Start Up experience and are looking for a new contract in the coming months then feel free to get in touch.

    JOB TITLE

    Freelance Clinical Research Associate

    1.0 FTE

    12 months

    LOCATION

    France, Belgium, Germany and Austria

    Home based

    RATE

    Competitive rate + Expenses

    ROLE

    Working directly with the sponsor you will implement and monitor trials across a wide spectrum of therapeutic areas, ensuring that sponsor and investigator obligations are met, and overseeing compliance with ICH GCP and European regulatory requirements. You will carry out monitoring visits including initiation, routine monitoring and close out.

    REQUIREMENTS

    +5 years monitoring experience

    Experience working in a Medical Devices or Pharma Company

    Previous experience in Oncology or Cardiovascular

    Phase II to IV experience is essential

  • UK

    £25000 - £30000 per annum, benefits
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    I am partnered with an innovative and cutting-edge Patient Recruitment Company focussed in Alzheimer’s who are looking for a Patient Recruitment Specialist for their growing team.

    This is a unique opportunity to for someone who enjoys working closely with patients and is keen to progress their career in a dynamic environment. You will be responsible for recruiting patients onto a variety of different studies whilst working closely with community leaders and research sites.

    Required experience:

    • 1 year plus experience working within clinical trials and patient recruitment
    • Strong communication and interpersonal skills
    • Experience working with seniors within Alzheimer’s/Dementia desirable
    • Good knowledge of Plymouth and surrounding areas


    For more information please contact Troy Neenan on 02072206237 or click apply.

  • £50000 - £65000 per annum, benefits
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    A leading Bio-Pharma is seeking an experienced Clinical Trial Manager to join their growing Late Phase team.

    This is a great opportunity to join one a leading company with structured career development and to work specifically within phase IV/observational studies. You will be responsible for managing global studies from start up to close out whilst working closely with the Program Manager.

    Responsibilities:

    • Manage global studies within late phase/investigator led studies
    • Manage CROs and other vendors
    • Oversee start up activities as part of a team

    Experience:

    • Experience in managing late phase studies
    • Experience working in complex therapy areas desirable
    • Degree educated within scientific discipline or equivalent


    For more info please contact Troy Neenan on 02072206237

  • UK

    £40000 - £60000 per annum, benefits
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    A cutting-edge Patient Recruitment company is seeking an experience Patient Recruitment Manager to join their growing team.

    This is a unique opportunity to move into a highly visible role within the UK whilst working closely with senior management. You will be responsible for overseeing patient enrolment for various research sites whilst leading a team of ambitious employees.

    Responsibilities:

    • Oversee patient enrolment and recruitment strategies
    • Work closely with research sites in order to hit enrolment targets
    • Oversee patient recruitment specialists and coordinators

    Experienced Required:

    • 2 years patient recruitment experience (Preferably at manager level)
    • Experience working with seniors a bonus
    • A track record of hitting and exceeding enrolment targets

    For more info please contact Troy Neenan on 02072206237 or click apply.

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    Field Clinical Research Associate

    Country (Location): East Germany

    Job Type: Permanent

    Travel: 75%

    Skills Alliance is currently partnered with a Global Medical Device company based in Germany that is seeking an experienced, high calibre Clinical Research Associate. For this purpose, we are currently supporting our client in their search on a retained basis.

    If you are a Clinical Research Associate with at least 3-4 years of experience monitoring within the Medical Device industry and are looking for a new opportunity, then feel free to get in touch.

    Primary Duties:

    • Clinical study site maintenance
    • Data and source documentation collection
    • Field monitoring of clinical trials

    Main responsibilities:

    • Ensuring compliance to the study protocol and monitoring plan
    • Site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections etc.
    • Maintains complete and accurate records of monitoring visits
    • Executing processes in the most effective and cost-efficient manner

    Education and Experience Requirements:

    • A Bachelor’s degree in natural science, pre-medicine, nursing, bio-engineering, or a related field
    • Minimum 3 years clinical research experience
    • Strong written and verbal communication skills and the ability to interpret basic clinical data
    • Basic IT Skills (i.e., word processing software and relevant clinical applications)
    • Ability to work independently in a global team environment and to exchange straightforward information
    • Proficient level of English and German
    • Relevant certification by an industry-recognized professional society
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    Skills Alliance are currently partnered with a Biometrics focused CRO that is currently expanding their Statistical Programming group globally. For this purpose, our client will be looking for multiple Freelance Statistical Programmers to join their team in the following locations: Europe, US, LATAM or India.

    If you are a Statistical Programmer with +3 years experience, programming within Oncology and immediately available (1.0 FTE) then feel free to get in touch ASAP.

    JOB TITLE

    Statistical Programmer

    12 months +

    LOCATION

    Europe, US, LATAM or India

    Home based

    RATE

    Competitive rate

    REQUIREMENTS

    +3 years programming experience

    Experience working in a Pharma Company

    Previous experience in Oncology is a must

    SDTM & ADaM experience is required, supporting submissions to the FDA knowledge is a plus

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    Skills Alliance are currently partnered with a Biometrics focused CRO that is currently expanding their Statistical Programming group globally. For this purpose, our client will be looking for multiple Freelance Statistical Programmers to join their team in the following locations: Europe, US, LATAM or India.

    If you are a Statistical Programmer with +3 years experience, programming within Oncology and immediately available (1.0 FTE) then feel free to get in touch ASAP.

    JOB TITLE

    Statistical Programmer

    12 months +

    LOCATION

    Europe, US, LATAM or India

    Home based

    RATE

    Competitive rate

    REQUIREMENTS

    +3 years programming experience

    Experience working in a Pharma Company

    Previous experience in Oncology is a must

    SDTM & ADaM experience is required, supporting submissions to the FDA knowledge is a plus

  • USA

    $180000 - $200000 per annum
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    This is an excellent opportunity to join one of the most exciting and fastest growing Biotech’s in the Greater Boston area with a robust late stage pipeline in oncology.

    As the Associate Medical Director of Clinical Development, you will take on a leadership role in executing the clinical trial strategy and design for a number of critical clinical trials. The successful applicant will have the rare opportunity to gain product launch experience to aid further progression to a more senior role.

    In this role, you will be responsible for helping in the development of study protocols, clinical development plans, and other study documents. You will act as the medical monitor and liaison between other departments ensuring cross-functional collaboration for study execution. Participating in the development of study protocols and documents will be an imperative aspect to this role as well.

    You must have a MD or DO and a minimum of 1 year of Clinical Development experience in a pharmaceutical setting. You must also have a background within oncology. A US MD would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the oncology space. With over 5 late phase products currently in the pipeline, this is the right time to be joining this truly innovative team!

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    A Senior Regulatory Adviser is needed to support the registration of an exciting new maternal health drug worldwide.

    This NGO (Non – Governmental Organisation) is a leading research-based multinational pharmaceutical company that operates independently of government and aims to deliver resources to ensure women and men worldwide have equitable access to sexual and reproductive health products.

    This exciting opportunity will see you at the fore front of ensuring a quality drug is available at the lowest possible cost for those in developing countries. This NGO has offices in Europe and Asia.

    As part of the project team. your main Senior Regulatory Adviser duties will be:

    • Collect and evaluate regulatory requirements to prepare regulatory strategy and timelines for submissions to multiple Regulatory Authorities;
    • Prepare regulatory submissions (e.g. registration dossier, variations, scientific advice submissions) for Regulatory Authorities, ensuring that submissions are of high quality and meet all regulatory requirements for smooth and fast approval;
    • Coordinate with the local agents for successful submissions and achievement of the Marketing Authorization/s;
    • Negotiate with Regulatory Authorities and other key stakeholders to facilitate regulatory approval;
    • Liaise with the manufacturers/clinical researchers and/or collect scientific literature data to compile clear arguments and responses to Regulatory Authorities’ questions and comments within the requested timeframe;
    • Provide expert advice about regulatory requirements for other related new products to Concept Foundation’s technical team and partner product manufacturers;
    • Keep up-to-date with changes in regulatory legislation and guidelines;
    • General regulatory and maintenance tasks.

    As Senior Regulatory Adviser you will be required to:

    • University degree (Master’s degree or equivalent degree) in Science (e.g. Chemistry, Pharmacy, Regulatory Affairs or equivalent);
    • A minimum of 5 years’ experience in international drug regulatory affairs, preferably with drug registrations in e.g. Africa, CIS, Latin America, Asia –Pacific regions;
    • Knowledge of WHO and European pharmaceutical legislation, relevant guidelines, procedures and requirements;
    • Ability to interface with Regulatory Authorities and our Client;
    • Ability to travel and work in an international environment;
    • Good technical writing skills and ability to communicate effectively internally and externally in English;
    • Fluency in English is mandatory, knowledge of French language is desirable.
    • You must be based in Europe and have a valid EU-25/EFTA citizenship. The organization can offer a flexible environment for the successful candidate where the Senior Regulatory Adviser is not domiciled in Switzerland.

    This is a full-time opportunity offering a competitive salary.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IONGO

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    Skills Alliance are currently partnered with a Biometrics focused CRO that is currently expanding their Statistical Programming group. For this purpose, our client will be looking for multiple Freelance Statistical Programmers to join their team home based in the following locations: New Jersey and Boston.

    If you are a Statistical Programmer with +3 years experience, programming within Oncology and immediately available (1.0 FTE) then feel free to get in touch ASAP.

    REQUIREMENTS

    +3 years programming experience

    Experience working in a Pharma Company

    Previous experience in Oncology is a must

    SDTM & ADaM experience is required, supporting submissions to the FDA knowledge is a plus

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    Skills Alliance are currently partnered with a Biometrics focused CRO that is currently expanding their Statistical Programming group. For this purpose, our client will be looking for multiple Freelance Statistical Programmers to join their team home based in the following locations: Boston and New Jersey.

    If you are a Statistical Programmer with +3 years experience, programming within Oncology and immediately available (1.0 FTE) then feel free to get in touch ASAP.

    REQUIREMENTS

    +3 years programming experience

    Experience working in a Pharma Company

    Previous experience in Oncology is a must

    SDTM & ADaM experience is required, supporting submissions to the FDA knowledge is a plus

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    Clinical Trial Assistant (CTA)

    Country (Location): Belgium (Brussels Area)

    Job Type: Permanent

    Skills Alliance is partnered with a multinational company, which provides clinical research services to the pharmaceutical and medical device industry globally. They are looking for a Clinical Trial Assistant (CTA) based in Belgium around the Brussels area. For this purpose, we are currently supporting our client in their search.

    If you have a background in and/or experience as a Medical/Administrative Assistant and speak very good Dutch and English, then feel free to get in touch.

    Main responsibilities:

    • Assisting the project team with general administrative tasks
    • Preparing and updating documents related to the clinical trials
    • Aiding with the preparation and submission of submission packages to the Ethics Committees
    • Correspondence with internal/external clients
    • Arranging investigator/general meetings and international travel
    • Using the Clinical Trial Management System to enter, update and track records

    Requirements:

    • Medical/Administrative Assistant Bachelor’s degree (or equivalent)
    • Very good Dutch and excellent English skills
    • Good communication, organizational, and teamworking skills
    • Attention to detail
    • Microsoft Office knowledge
    • Some experience is considered a plus
  • UK

    £25000 - £30000 per annum, benefits
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    I am partnered with an innovative and cutting-edge Patient Recruitment Company focussed in Alzheimer’s who are looking for a Patient Recruitment Specialist for their growing team.

    This is a unique opportunity to for someone who enjoys working closely with patients and is keen to progress their career in a dynamic environment. You will be responsible for recruiting patients onto a variety of different studies whilst working closely with community leaders and research sites.

    Required experience:

    • 1 year plus experience working within clinical trials and patient recruitment
    • Strong communication and interpersonal skills
    • Experience working with seniors within Alzheimer’s/Dementia desirable
    • Good knowledge of Plymouth and surrounding areas


    For more information please contact Troy Neenan on 02072206237 or click apply.

  • £50000 - £65000 per annum
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    An independent Health Economics consultancy is offering a Health Economist position with flexible working in London.

    This is an opportunity to join a friendly and professional company that is specialising in delivering health economic solutions to support access to new health technologies. As part of this growing company you can make a difference and develop with them. They build clear Health Economic models from concept to conclusion, participate in health technology assessments (HTA) and help with complex reimbursement procedures.

    You would be responsible for helping the team to deliver projects around evidence generation, cost-effectiveness models and budget impact analysis, training junior members on HTA submissions and working on real world data.

    The Consultant role is office based mostly with couple of days remote work opportunity. This permanent position is for hands-on individuals who are passionate about Health Economics and want to earn well. The role is offering above the average, all depending on your experience.

    Skills Alliance are the preferred supplier for this role. Please contact Ottilia Molnar for more details on +44/2072206224.

  • £60000 - £75000 per annum, benefits
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    I am working with a growing Ophthalmology focussed CRO who are looking for an experience Clinical Project Manager to join their team. This is a great opportunity to work closely with the VP of Clin Ops on global studies and be a highly visible member of the team in the UK.

    The company is looking for this person to be their next Director so there is excellent opportunity for growth.

    Responsibilities:

    • Manage global studies across a variety of different phases
    • Manage study budgets
    • Work cross functionally with other departments

    Experience:

    • CRO experienced required
    • Experience working on Ophthalmology studies
    • Scientific Degree or equivalent required

    For more info please contact Troy Neenan on 02072206237 or click apply.

  • USA

    $150000 - $175000 per annum
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    An industry leading pharmaceutical and healthcare consulting agency is in urgent need of Principal Consultant focused in the Market Access space. The Principal Consultant would be joining one of the largest organizations in the field to help provide strategic input to some of their key accounts which include some of the largest pharmaceutical companies. The company is in a position where they are rapidly growing which equates to a great opportunity to have an accelerated career.

    As a subject matter expert, the Principal Consultant would be serving their clients to ensure that each client is aware of potential managed care concerns and provide solutions for those issues. The Principal consultant will also be responsible for identifying new business leads and collaborating with the sales team to develop an approach to secure new business.

    The ideal Principal Consultant would have 5 plus years of experience in the Market Access/Managed Care field and strong experience with engaging clients. This Principal consultant should also be familiar with engaging with payors.

  • £60000 - £70000 per annum
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    A world-class mid-size pharma are recruiting for an EMEA Medical Advisor position based in the Hertfordshire area.

    You will have the opportunity to join a patient-driven global pharmaceutical company located north of London, who have an extensive Neurology portfolio and are expanding worldwide, offering you opportunities for progression and growth.

    This is a cross-functional and strategic Medical Affairs role at EMEA level. You would liaise with the EMEA Scientific Director to support EMEA Medical Affairs plans, provide scientific, medical and technical support, marketing, training and sales activities for the Neurology portfolio in line with the EMEA strategy.

    The EMEA Medical Advisor position is an office-based role offering flexibility to work from home and international travel involved. The salary offered is between £ 60000-70000 (depending on experience) + benefits + bonus + car allowance.

    Previous Medical Affairs experience and GMC/GPhC registration is required.

    Medical Final Signatory is preferred.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

  • £75000 - £85000 per annum, Bonus and Benefits
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    A leading Biotech organization based in Central London are recruiting for a Principal Investigator to supervise early phase trials.

    You will have the opportunity to join an expanding company which is a pioneering clinical trial platform for the development of Respiratory Disease products. Their portfolio also includes Infectious Disease and Immunology.

    The role will be an exciting opportunity for physicians working in clinical development to gain exposure in phase I/II trials and work in close contact with the patients. In cooperation with other clinical units, the Principal Investigator will lead the staff during the development of clinical trials, along with supervising patient screenings and directing medical duties.

    The Principal Investigator position is an office-based role located in the heart of London. It is a permanent position offering around 75-85K depending on the experience + bonus and benefits. GMC registration is required.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire an International Medical Science Liaison as part of their global team build in Medical Affairs.

    The company has an innovative and active research pipeline focused on enzyme therapies in pre-clinical and clinical stage for ultra-rare and oncologic diseases. Following successful Phase II data on the lead asset, a global Phase III trial is now underway.

    To support the VP Global Medical Affairs, the company is hiring an International MSL to cover the DACH region. This is a rare opportunity for a scientifically driven, patient-centric individual to help devise and shape the medical strategy and bring an ultra-orphan drug to market in 2020/2021. This would represent the only approved treatment for a debilitating disease currently managed by diet only.

    Job Responsibilities:

    • Create and implement strategic Medical Affairs plans in line with the biotech’s product development objectives
    • Build an extensive regional KOL network to ensure successful implementation of the medical strategy
    • Implement local pharmaceutical regulations and company policies and procedures
    • Be a reliable and trusted source for accurate medical and scientific knowledge, providing product information and the disease state as requested in an accurate and timely manner
    • Feed back field insights to internal stakeholders and coordinate with internal teams
    • Collaborate with Clinical and Regulatory teams in identifying sites, recruitment, evaluation and training to advance clinical trial execution at study sites
    • Implement medical affairs practices to assess potential new indications, including the treating community, patient pathways, diagnostic practices and management
    • Identify potential high-impact medical research projects and publication opportunities, in line with the company’s’ identified areas of interest
    • Conduct training with CRO, CRAs and study site staff as required
    • Support cross-functional collaboration to ensure operations are patient-focused

    Qualifications:

    • Advanced scientific degree (PhD, PharmD, MD)
    • Prior industry experience in a similar MSL role
    • Specialty / rare / orphan / metabolic disease preferred (experience in neurology also an advantage)
    • Willingness for up to 70% travel time
    • Excellent rapport building and interpersonal skills
    • Strong command of the English language

    The role will involve paving the way for pioneering science with great autonomy and accountability for the medical strategy, with a direct reporting line and exposure to senior management.

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