Associate Director Medical Writing
On-siteSouth San Francisco, California, United States
Job Summary
Lead clinical and regulatory writing across one or more programs by authoring study protocols, clinical study reports, DSURs, investigator's brochures, and IND summaries. Partner with Clinical Science and Regulatory Affairs to align document strategy, prepare submission materials, and respond to regulatory inquiries. Provide direction and oversight to external vendors while managing timelines and quality expectations. Contribute to process improvements, refine templates and style guidelines, and establish SOPs with Quality Assurance to ensure compliance with ICH and global standards. Requires a Master's degree, 8+ years of experience, and proficiency in document management platforms.
Required Qualifications
- Advanced degree in a life sciences field
- Master's degree
- 8+ years of medical or scientific writing experience
- experience within biotech, pharmaceutical, or CRO environments
- Deep familiarity with global regulatory requirements
- ICH guidelines knowledge
- FDA guidelines knowledge
- EMA guidelines knowledge
- Health Canada guidelines knowledge
- APAC guidelines knowledge
- Demonstrated experience authoring a broad range of clinical and regulatory documents
- Experience supporting Investigator-Initiated Trials
- collaborating with external investigators
- Proficiency with Microsoft Office
- Proficiency with Adobe Acrobat
- Proficiency with document management/review platforms
- SharePoint proficiency
- Veeva RIM proficiency
- Experience managing external vendors
- experience managing contract writers
- Strong organizational skills
- attention to detail
- Excellent written communication abilities
- Excellent verbal communication abilities
- Self-starter mindset
- ability to operate in a fast-paced, evolving environment
- Comfortable working in a highly collaborative, hands-on setting
Desired Qualifications
- PhD degree
- PharmD degree
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