Senior Manager Regulatory Affairs Writing
2 weeks ago
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 matt.thomas@pharma-partners.co.uk
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