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Senior Manager Regulatory Affairs Writing - Cambridge, Cambridgeshire, United Kingdom - Pharma Partners Recruitment Ltd
Description
Job 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 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 manage the medical and regulatory writing team along with use of external writing resources when necessaryand coordinate the development of cross-functional documents to ensure completion to 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) writing in the field of Clinical Development within the pharmaceutical industry or contract research organisationsin writing for clinical trials across a range of therapeutic areas and geographies, ideally with immunology/dermatology experienceexperience 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 offerTo apply for this position or hear further details then please contact Matt Thomas via