Skills
Clinical and regulatory writing
Regulatory document quality and compliance
Cross-functional review coordination
About the Role
As a Senior Strategic Medical Writer, you will lead the creation of clinical and regulatory documentation that supports drug and/or device development. You’ll partner with internal experts to ensure materials are accurate, compliant, and aligned with company objectives and submission strategies.
Responsibilities
- Draft and prepare clinical and regulatory documents for drug and/or device development
- Work with a moderate level of autonomy on initial drafts, incorporating feedback from subject matter experts and senior writers as needed
- Support submission strategy development by building knowledge of regulatory expectations and document purpose
- Coordinate cross-functional review, approval, and quality control activities for clinical and regulatory deliverables
- Organize and facilitate review meetings to align on content, timelines, and quality standards
- Maintain high-quality, compliant documentation and help ensure timely delivery of project outputs
Requirements
- Experience writing clinical and regulatory documents for drug and/or device development
- Strong understanding of quality and compliance expectations in regulatory documentation
- Ability to collaborate effectively with subject matter experts and cross-functional teams
- Experience coordinating document reviews and maintaining version control and quality
Benefits
- Remote work flexibility
- Opportunity to contribute to impactful clinical and regulatory programs
- Collaborative environment with subject matter experts and experienced writers
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