Associate Director Medical Writing

Role: Associate Director, Medical Writing, responsible for developing and executing strategies for clinical and regulatory documents in oncology drug development, ensuring high-quality submissions. Responsibilities include authoring and leading complex clinical/regulatory documents such as protocols, IB updates, CSRs, DSURs, and eCTD modules, collaborating across functions like clinical development, regulatory affairs, and biostatistics, and managing contract writers. The role emphasizes maintaining document standards, supporting inspection readiness, and ensuring compliance with GxP, GCP, and ICH guidelines. Qualifications: Advanced degree in life sciences (PhD preferred), 5-8+ years of biotech/pharma medical writing experience with oncology focus, proven NDA and eCTD module expertise, especially in clinical summaries and regulatory submissions. High-value: oncology, clinical development, regulatory submissions, NDA experience, eCTD module authoring, cross-functional collaboration. Work setup: not specified; requires strong project management, communication, and collaboration skills, proficiency in MS Office and Veeva Vault preferred.