Associate Director, Medical Writing

• 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 documentation.
• Drive document strategy by leading data interpretation discussions and shaping key scientific messaging to ensure consistency across deliverables.
• Oversee timelines and deliverables in collaboration with program management, ensuring alignment with submission goals and regulatory milestones.
• Translate complex clinical and scientific data into clear, concise, and submission-ready documentation aligned with global regulatory expectations.
• Manage document review cycles, facilitating cross-functional input, resolving comments, and ensuring timely progression to finalization.
• Perform and/or oversee quality control reviews to ensure accuracy, consistency, and adherence to internal standards and external regulatory requirements.
• Partner with Quality Assurance to address audit findings and ensure inspection readiness of documentation.
• Collaborate closely with Regulatory Operations to support document formatting, publishing, and submission readiness.
• Contribute to responses to health authority inquiries and support regulatory interactions as needed.
• Provide mentorship, guidance, and informal leadership to junior medical writers, helping to elevate overall team capabilities.
• Maintain up-to-date knowledge of global regulatory guidance and industry best practices.

Qualifications & Experience

• Bachelor’s degree required; advanced scientific or clinical degree (e.g., PhD, PharmD, MD) strongly preferred.
• Approximately 10+ years of medical writing experience within the pharmaceutical or biotechnology industry, with significant exposure to regulatory submissions.
• Demonstrated leadership in authoring key components of global filings, including CTD summaries (e.g., Clinical Overview and Clinical Summaries).
• Extensive experience developing core regulatory documents such as CSRs, protocols, investigator brochures, INDs, and NDA/BLA components.
• Strong expertise in safety and efficacy data interpretation and presentation within regulatory documents.
• Deep familiarity with global regulatory standards and guidelines, including FDA, EMA, and ICH (e.g., E3, E6).
• Proven ability to independently lead complex writing projects and manage competing priorities in a fast-paced environment.
• Experience mentoring or supporting the development of junior writers is highly valued.
• Strong analytical skills with the ability to synthesize large volumes of data into meaningful insights.
• Working knowledge of AMA style and regulatory document formatting conventions.