Your new company I'm currently supporting an exciting opportunity with an innovative biotechnology organisation developing cutting-edge therapies. We're looking for an experienced Senior Manager, Medical/Regulatory Writer to lead and oversee regulatory and medical writing activities across clinical development programmes, supporting submissions from First-in-Human studies through to product registration. Location: Remote (UK-based), ability to attend the Oxford office 1-2 days per week would be advantageous.Contract: 12 Months initially Your new role Key Responsibilities Lead regulatory and medical writing activities across assigned development programmes Author and review key regulatory documents including: Clinical Study Protocols Clinical Study Reports (CSRs) Investigator Brochures (IBs) DSURs Clinical Overviews and Clinical Summaries Health Authority Briefing Documents Responses to Regulatory Agency Questions IND/CTA and CTD/BLA/MAA submission documentation Coordinate and manage external contract writers Ensure consistency of regulatory messaging across programmes Partner with Clinical, Regulatory, Pharmacovigilance, Translational Medicine, Medical Affairs, and Preclinical teams Contribute to medical writing best practices, process improvements, and submission s...
Senior Manager Regulatory / Medical Writer employer: Hays Specialist Recruitment Limited Careers
Hays Education is an exceptional employer, offering a supportive and collaborative work environment for SEN SLD/PMLD teachers in the Hounslow/Hillingdon area. With access to exclusive vacancies, ongoing professional development, and a dedicated consultant to guide your career, you will find ample opportunities for growth while making a meaningful impact on the lives of pupils with special educational needs. Join us to be part of a community that values inclusivity and fosters both personal and professional development.
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Hays Specialist Recruitment Limited Careers Recruitment Team
