The Sr Manager, Medical Writing will lead the development of high-quality, compliant English-language non-clinical, clinical, and regulatory documents within the Medical Writing department at Servier Pharmaceuticals US.
Requirements
- Serve as the main medical writing contact on study teams ensuring accuracy, consistency, and regulatory compliance in a variety of clinical regulatory documents
- Author, edit, and manage project deliverables, including timeline development, project management, and active participation on cross-functional project teams
- Prepare responses to questions from regulatory agencies; write briefing packages, other strategic regulatory documents
- Mentor and manage the work of junior writers as needed
- Manage the work and deliverables of contract/vendor writers, as needed
- Promote continuous improvement by influencing cross-functional practices to enhance quality, compliance, and efficiency
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Flexible time off
- 401(k)
- Life insurance
- Disability insurance
