Associate Director, Medical Writing
188311
Posted: 16/03/2026
- $230,000.00
- San Francisco United States
Key Responsibilities
- Document Leadership and Authoring:
- Provides medical writing leadership for clinical programs
- Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
- Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
- Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
- Process Improvement:
- Develops medical writing best practices
- Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements
- Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
- Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
- Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
- Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
- Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)
- Experience in resource planning and management experience of contractors
- Excellent organization skills with a passion for delivering quality results
- Detail-oriented mindset with excellent verbal and written communication skills
- Self-motivated and able to work collaboratively
- Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
- Must be willing to work onsite at least 4 days a week
Paul Rappa
Senior Division Manager
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