Sr Manager, Medical Writing

Role: Senior Manager, Medical Writing, leading development and oversight of clinical documentation for biopharma programs. Responsibilities: produce high-quality clinical protocols, investigator brochures, study reports, safety summaries; manage review processes; represent Medical Writing on project teams; collaborate with Biometrics, Clinical Operations, Regulatory Affairs, and external stakeholders; contribute to SOPs and templates. Requirements: Bachelor's in Life Science or Communications, 6+ years of medical writing in sponsor/CRO settings; deep understanding of GxP, FDA, ICH guidelines; experience with regulatory submissions (CTA/IND/NDA/BLA) and eCTD formatting preferred; proficient in Microsoft Office; demonstrated ability to manage multiple projects in fast-paced environments; willing to travel ~10%. HighValue: experience in early and late-phase clinical development, strong regulatory knowledge, leadership in document production, and cross-functional collaboration.