Director, Medical Writing
ProPharma Group · US
Medical AffairsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
ProPharma Group seeks a Director of Medical Writing to lead departmental initiatives, manage client relationships, and oversee medical writing and quality control deliverables across regulatory submissions and clinical documents. The role involves business development, team leadership, and independent authorship of complex regulatory documents.
What they're looking for
- Bachelor's degree or higher in medical or scientific discipline
- Expert knowledge of clinical research principles and FDA regulations
- Advanced proficiency with MS Word, tables, graphs, and figures
- Leadership, project management, and exceptional communication skills
- Experience in business development and medical writing capabilities presentations
- Strong process improvement skills specific to medical writing and quality control
- Valid passport with availability for domestic and international travel
What you'll be doing
- Lead medical writing business development efforts including proposals, bids, and bid defense presentations
- Manage and develop direct reports; oversee medical writing and quality control deliverables
- Independently author and manage complex regulatory documents such as INDs, NDAs, BLAs, and eCTD submissions
- Organize departmental initiatives and cross-functional coordination of resources across projects
- Review and mentor less experienced medical writers on clinical, safety, and regulatory documents
Privacy & handoff
This role links to ProPharma Group's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.