Director, Clinical Regulatory Writing (Program Lead)
Core
Provides expert communications leadership across clinical programs, driving collaboration and growth within Clinical Regulatory Writing to achieve successful submissions and approvals.
Role type
Senior IC clinical regulatory writing program lead with line management responsibilities
Builds
Clinical-regulatory documents and submissions for drug projects
Domain
Pharmaceutical/Biotech, Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic communication, cross-functional drug development understanding, regulatory requirements knowledge, vendor management, performance management, risk mitigation, business process optimization
Preferred skills
Ph.D. in scientific discipline, expert industry reputation, extensive supervisory experience managing multiple direct reports or contract staff
Technologies
Clinical regulatory document authoring tools, submission management systems
Responsibilities
Oversee communication strategy for a group of submissions or programs, drive knowledge sharing across program teams, influence stakeholders to establish best communications practices, lead submission activities or author key documents, review submission documents for consistency, coach and mentor clinical regulatory writers, manage performance development and succession activities, interface with medical writing vendors for contracting and oversight
Seniority
Director, hands-on IC with line management duties
