Senior Manager, Medical Writing

Role: Senior Manager, Medical Writing responsible for developing high-quality clinical documents in compliance with regulations, GCP, and SOPs. Responsibilities: independently produce and manage clinical protocols, investigator brochures, study reports, and safety summaries; oversee review processes; serve as subject matter expert; collaborate with cross-functional teams including Biometrics, Clinical Operations, Regulatory, and Quality; contribute to SOPs and templates. Requirements: Bachelor's in Life Science or Communications; 6+ years of medical writing experience in sponsor or CRO settings; knowledge of FDA regulations, ICH guidelines, and drug development; experience with regulatory submissions (CTA/IND/NDA/BLA) and eCTD formatting is a plus; proficiency with MS Office; ability to travel ~10%. HighValue: expertise in clinical documentation, regulatory submission experience, GCP knowledge, cross-functional collaboration, and oversight of contract writers. WorkSetup: not specified but involves collaboration across teams.