Associate Director of Medical Writing

Job Description

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

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

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