Senior Director, Medical & Regulatory Writing

📋 Description

• Leads Medical & Regulatory Writing team and strategy.
• SME for clinical protocols, CSRs, Investigator's Brochure, and briefing books.
• Rep medical writing in cross-functional team meetings.
• Collaborates with cross-functional teams to deliver high-quality docs on time.
• Adheres to ICH/FDA standards and company SOPs.
• Oversees vendors and develops templates, SOPs, and workflows.

🎯 Requirements

• Bachelor’s, Master’s or PhD in scientific field; advanced degree preferred.
• Strong people management and delegation experience.
• 12+ years medical writing in pharma/biotech/CRO; oncology preferred.
• Experience authoring CSRs, protocols, amendments, IBs; briefing books a plus.
• FDA/ICH knowledge; familiarity with eCTD templates and formatting tools.
• Editing for brevity and clarity with high attention to detail.

🎁 Benefits

• Career advancement and development opportunities
• Competitive compensation package with bonus eligibility
• 401K + employer contributions and generous stock options
• ESPP Plan and comprehensive benefits
• 20 days PTO plus 18 holidays
• Paid parental leave and commuter/home office stipends