BioPhase

Remote - must be located in the United States - West Coast hours Associate Director, Medical Writing (Regulatory) The Associate Director of Medical Writing will serve as a strategic and scientific leader within the organization, responsible for driving the development and delivery of high-quality regulatory documents across multiple programs. This role operates as a senior individual contributor with leadership responsibilities, reporting into the Head of Regulatory & Medical Writing. While the position can be performed remotely, candidates based in or near San Diego are preferred. Key Responsibilities Lead the authoring and end-to-end development of complex regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures, briefing packages, and global marketing application summaries (e.g., CTD Module 2). Act as the medical writing representative on cross-functional program teams, providing strategic input on clinical and regulatory...