Associate Director, Medical Writing (Regulatory)
Skills
- Regulatory writing
- Document preparation
- Data presentation
- Strong communication
- Regulatory guidelines knowledge
- Proficiency in eCTD templates
Responsibilities
- Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
- Plan, prepare, write, edit, format, and finalize regulatory documents
- Oversee document preparation activities and track progress
- Provide oversight of document quality and consistency
- Lead document review and comment resolution processes
- Leverage scientific expertise to write, review, and edit science-based documents
- Coordinate the review and approval of documents
- Develop templates, style guidelines, and SOPs for regulatory documentation
Education
- JD/Paralegal degree with scientific background
- Advanced scientific degree (MS, PhD or PharmD)
Benefits
- Competitive salary
- Comprehensive health benefits
- 401(k) plan
- Career development opportunities
Average salary estimate
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