Principal Medical Writer

Role: Principal Medical Writer (equivalent to Associate Director) specializing in clinical document development within biopharma. Objectives: produce high-quality regulatory and clinical documents, lead supplemental filings, and provide medical writing expertise to project teams. Responsibilities: independently develop protocols, study reports, investigator brochures, and regulatory submissions, oversee external writers, facilitate review processes, and contribute to process standardization. Collaborate closely with Biometrics, Clinical Operations, R&D, Quality, and external stakeholders. Qualifications: Bachelor's in Life Science or Communications with 7+ years' medical writing experience, preferably in sponsor/CRO settings; deep knowledge of GCP, FDA regulations, ICH guidelines, and drug development stages. Preferred skills include experience with NDA/BLA/MAA submissions, eCTD formatting, EDMS systems, and managing contract writers. High-Value: focus on clinical development, regulatory submissions, and cross-functional collaboration in a fast-paced setting. Work setup and travel details are not specified.