Associate Director, Global Scientific and Regulatory Documentation, Content Strategy

Role: Lead the authoring and coordination of complex regulatory documents (e.g., Pivotal Phase 3 CSRs, CTD summaries, Pediatric Investigational Plans) to support global regulatory submissions for assets in immunology and cardiovascular areas. Responsibilities: manage document strategy, ensure compliance with standards, collaborate with cross-functional teams, and oversee review processes to ensure timely, high-quality submissions. Requirements: PharmD/PhD/MD or equivalent with approximately 10 years of regulatory documentation experience in pharma, demonstrated expert writing skills, understanding of global drug development and submission requirements, strong organizational and communication skills, and familiarity with document management systems. Preferred: experience in immunology and cardiovascular therapeutic areas, complex document management, and state-of-the-art documentation technologies. High-Value: focus on global regulatory submissions for biologics or small molecules in late-stage development (Phase 3), supporting IND/CTD documentation. Work setup: location details not specified; requirements for remote or onsite work are not provided.