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Pharma Partners Recruitment Ltd
Cambridge
Job DescriptionJob title: Senior Manager Regulatory Affairs WritingA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. The role will play a pivotal role in the clinical development team. You will lead a team responsible for developing the content for submissions to both US and EU regu
Job Source: Pharma Partners Recruitment LtdHays
GB
Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contra
Job Source: HaysPharma Partners Recruitment Ltd
Cambridge, England, United Kingdom
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Job Source: Pharma Partners Recruitment LtdPharma Partners Recruitment Ltd
Cambridge
Job DescriptionJob title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition
Job Source: Pharma Partners Recruitment LtdOmega Diagnostics Ltd
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Job Source: Omega Diagnostics LtdHays Specialist Recruitment Limited
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Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contrac
Job Source: Hays Specialist Recruitment LimitedServe Talent
Bury St. Edmunds
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Job Source: Serve TalentNewton Colmore Consulting Ltd
Cambridge
Medical Devices Consultant - Senior Mechanical Engineer - Cambridge Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role. The company is based in Cambridge and boasts some of the most i
Job Source: Newton Colmore Consulting LtdCambridge, England, United Kingdom
Job title: Senior Manager Regulatory Affairs Writing
A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. The role will play a pivotal role in the clinical development team. You will lead a team responsible for developing the content for submissions to both US and EU regulatory agencies.
Responsibilities:
scientific contribution to the development of medical, regulatory and clinical documents to support development programmes. This includes (not limited to) clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
and manage the medical and regulatory writing team along with use of external writing resources when necessary
and coordinate the development of cross-functional documents to ensure completion to timelines.
and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
Requirements:
of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.
of writing in the field of Clinical Development within the pharmaceutical industry or contract research organisations
in writing for clinical trials across a range of therapeutic areas and geographies, ideally with immunology/dermatology experience
experience in medical communications, editing and/or publishing would be advantageous
Salary and benefits:
A highly competitive salary, stock options, annual bonus and wider benefits scheme is on offer
To apply for this position or hear further details then please contact Matt Thomas via [email protected]
Senior Manager Regulatory Affairs Writing jobs in Cambridge, England, United Kingdom
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