Associate Director, Regulatory and Medical Writer

Role: Associate Director of Regulatory and Medical Writing leading complex clinical and regulatory document development to support global filings and development programs. Responsibilities: authoring and delivering key documents such as clinical study reports, Module 2 summaries, Investigator’s Brochures, protocols, and briefing packages; providing strategic input on document planning and submission strategies; leading cross-functional teams; ensuring compliance with international regulations; mentoring junior staff; managing review cycles and quality control. Requirements: Bachelor's degree (advanced in scientific or regulatory fields preferred), 12+ years in pharmaceutical medical writing with expertise in regulatory documents for major submissions, including safety sections; proven leadership in regulatory writing for INDs, NDAs, and marketing applications; deep knowledge of FDA, EMA, ICH guidelines (notably ICH E3, E6[R3]); strong project management and communication skills; proficiency with document management systems like Veeva and familiarity with style guides. High-value specifics: extensive experience with global regulatory submissions, safety data interpretation, and regulatory designations (e.g., Orphan Drug, Breakthrough). Collaboration: works closely with Clinical Development, Regulatory Affairs, Biostatistics, and Safety teams; reports to the Executive Director of Regulatory and Medical Writing. Work setup: potentially remote, with preference for San Diego-based candidates.