Associate Director, Medical Writing

Associate Director, Medical Writing

Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!)

• Relocation Assistance Available

About the Opportunity

Our client is seeking an experienced Associate Director, Medical Writing to provide strategic leadership and functional oversight for the development of high-quality clinical and regulatory documents. This individual will serve as a key cross-functional partner, driving document strategy, authoring, review management, and process improvements across clinical development programs.

Key Responsibilities

Medical Writing Leadership & Document Development

• Provide medical writing leadership across multiple clinical development programs.
• Serve as the primary author and/or lead reviewer for key clinical and regulatory documents, including:
• Clinical Study Protocols and protocol-related documents
• Informed Consent Forms (ICFs)
• Clinical Study Reports (CSRs)
• Development Safety Update Reports (DSURs)
• Investigator’s Brochures (IBs)
• IND clinical summaries and overviews
• CTD Module 2 clinical summaries
• Partner closely with Clinical Science, Clinical Operations, Regulatory Affairs, Biostatistics, and other cross-functional stakeholders to ensure high-quality, submission-ready documentation.
• Support preparation of health authority meeting requests, briefing documents, responses to regulatory inquiries, and additional submission-related documentation.

Vendor & Project Management

• Manage and oversee external medical writing resources and vendors.
• Provide direction on document strategy, timelines, content development, and prioritization.
• Drive efficient document planning and execution to support clinical and regulatory milestones.

Process Excellence & Continuous Improvement

• Establish and maintain medical writing standards, templates, style guides, and best practices.
• Collaborate with Quality Assurance and cross-functional teams to develop and update SOPs and document development processes.
• Ensure compliance with global regulatory requirements and industry standards, including ICH guidelines and applicable health authority expectations.

Qualifications

• Master's degree in Life Sciences or a related scientific discipline required; PharmD or PhD preferred.
• 8+ years of medical writing experience within biotechnology, pharmaceutical, or CRO environments.
• Extensive experience authoring and leading the development of clinical and regulatory documents.
• Strong knowledge of global regulatory requirements and guidance, including FDA, EMA, ICH, Health Canada, and other international regulations.
• Experience supporting investigator-sponsored studies and clinical development programs.
• Proficiency with Microsoft Office Suite, Adobe Acrobat, document management systems, and collaborative review platforms.
• Experience managing external vendors and contract resources.

Please apply for the full job description and company information!