Executive Director, Medical Writing
Regeneron
Regeneron seeks an Executive Director of Medical Writing to provide strategic leadership for medical writing, editing, and resourcing across therapeutic areas. The role encompasses department strategy development, technology integration, staff management, and oversight of clinical regulatory document submissions.
Responsibilities
- Develop and lead medical writing strategies, standards, and guidelines across therapeutic areas
- Oversee planning, authoring, review, and delivery of clinical regulatory documents
- Develop resourcing strategies including staffing plans and external consultant support allocation
- Manage and develop medical writing and editing staff through performance reviews and professional development
- Lead technology adoption and process improvement initiatives across the department
Requirements
- Bachelor's degree; advanced degree preferred
- Minimum 17 years industry experience including 10+ years in medical writing
- Minimum 7 years management experience
- Expert knowledge of clinical research processes, regulations, and guidelines
- Advanced proficiency with MS Word, Adobe Acrobat, document management systems, and authoring platforms
- Demonstrated ability to evaluate and implement technology solutions for quality and efficiency
- Thorough understanding of ICH GCP guidelines
Vacancy posted 1 day ago
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