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!