Senior Director, Clinical Writing

Job Summary

A company is looking for a Senior Director, Clinical and Regulatory Writing.

Key Responsibilities:

• Lead the development, review, and approval of regulatory documents for global submissions
• Oversee cross-functional content planning and ensure consistency in strategic messaging for regulatory submissions
• Manage a team of writers and external consultants, driving process improvements and ensuring high-quality document delivery

Required Qualifications:

• Advanced degree in life sciences (M.D. or PharmD preferred); MS or PhD with relevant experience may be considered
• 12+ years of experience in regulatory or scientific/medical writing, with 5+ years in a leadership role
• Experience with major global regulatory submissions, preferably in cell or gene therapy
• Strong understanding of drug development processes and regulatory frameworks (FDA, EMA, ICH)
• Proficiency in Microsoft Office Suite and document management systems