Associate Director / Director, Clinical Regulatory Writing (Program Lead)
Core
Lead clinical regulatory writing programs and submissions, developing communication strategies and ensuring document consistency for drug projects.
Role type
Senior IC clinical regulatory writer (program lead) with line management responsibilities
Builds
Clinical regulatory documents and submissions for drug programs
Domain
Life Sciences / Clinical Development / Regulatory Affairs
Required skills
Clinical regulatory writing, drug development process knowledge, cross-functional communication, vendor management, strategic thinking, team leadership
Preferred skills
PhD in a scientific discipline, expert industry reputation, extensive supervisory experience
Technologies
Clinical regulatory document systems, project management tools
Responsibilities
Oversee communication strategy for submissions, drive knowledge sharing across teams, optimize communication approaches, influence stakeholders on best practices, lead submission activities, review documents for consistency, coach and mentor writers, manage performance and recruitment, oversee vendor contracting
Seniority
Director, hands-on IC with line management