Author clinical sections of regulatory submissions and health authority interactions, including INDs, CTAs, briefing documents, Development Safety Update Reports, and responses to health authority and ethics committee questions; prepare for and present clinical content at meetings with FDA, EMA, and other health authorities. Partner with Clinical Operations, Biostatistics, Data Management, Clinical Pharmacology, Regulatory Affairs, Toxicology, and Drug Safety to deliver studies on plan, with medical input into case report form design, data review, interim and final analyses, and interpretation of results; provide medical oversight of CRO medical monitoring and safety services.