Associate Director of Medical Writing

• Remote - must be located in the United States - West Coast hours required

If the following job requirements and experience match your skills, please ensure you apply promptly.

Associate Director, Medical Writing (Regulatory)

The 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. xhyhwjd
• Working knowledge of AMA style and regulatory document formatting conventions.