Senior Manager, Medical Writing, Biopharma Regulatory
Overview
Own regulatory, clinical, and safety document strategy at scale within a leading biotech company focused on rare diseases. Lead cross-functional teams to produce high quality submissions and maintain alignment with FDA, EMA, ICH guidelines. Drive governance, templates, and standards across programs. Collaborate with global stakeholders to accelerate drug development and lifecycle management.
What You'll Do10
- 1Build and coordinate regulatory, clinical, and safety documents ensuring accuracy and regulatory compliance
- 2Lead cross-functional collaborations to develop, review, and finalize submission-ready documents
- 3Manage document development timelines and review cycles to ensure timely milestones
- 4Interpret and summarize complex clinical data into concise submission content
- 5Ensure adherence to FDA, EMA, ICH guidelines and industry standards
- 6Proactively improve medical writing processes, templates, style guides, and SOPs
- 7Develop therapeutic area expertise to support scientific and regulatory communication
- 8Maintain alignment across programs and drive continuous improvement in medical writing
- 9Provide leadership and mentorship to junior writers as needed
- 10Ensure on-site presence in San Diego and travel as required
Requirements10
- 1Bachelor's degree in Life Sciences or related field
- 27+ years of medical writing or regulatory writing experience in biotech, pharma, or CRO
- 3Strong knowledge of drug development processes and global regulatory requirements
- 4Experience authoring complex clinical and regulatory documents
- 5Ability to work independently and lead cross-functional teams
- 6Proficiency with Microsoft Office and Veeva platforms
- 7Excellent communication and project management skills
- 8Willingness to travel up to 10%
- 9MS, PharmD, or PhD preferred
- 10Ability to operate in a fast-paced, global development environment
Salary Insight
$132 - $172k per year
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