Associate Director, Medical Writing
About The Position
The Associate Director, Medical Writing independently plans, develops, and delivers high-quality, strategically aligned clinical and regulatory documents as an integral member of the clinical team. The role ensures scientific content, organization, clarity, accuracy, adequacy, formatting, and consistency, while adhering to regulatory requirements and internal guidelines, styles, and processes. It also provides leadership, subject matter expertise, and strategy for medical writing planning and coordination. The position works closely with cross-functional teams, advising on document content and format requirements and coordinating timelines and review responsibilities. It supports compliant clinical trial execution and inspection readiness, maintains awareness of regulations and relevant scientific developments, and contributes to process governance and improvement. The posting describes the role as fully remote and U.S.-based, but later states that it is hybrid, with on-site work at a Sarepta facility and/or attendance at company-sponsored in-person events from time to time.
Requirements
- Bachelor’s degree or equivalent; life sciences is preferred.
- 10 or more years of relevant experience, including 8 or more years of medical writing or other writing experience.
- Excellent writing skills.
- Ability to understand, interpret, and communicate clinical and scientific data.
- Essential knowledge of the drug development process and current regulatory requirements and guidelines applicable to GCP-, ICH-, and eCTD-compliant documents.
- Required prior NDA/BLA experience, with active contribution to preparation and writing of clinical and regulatory documents.
- Ability to multitask, manage competing priorities, and meet aggressive timelines.
- Experience and success working with cross-functional teams.
- Excellent interpersonal and communication skills.
- Flexibility and adaptability in a fast-paced, dynamic environment.
- Knowledge and application of Good Clinical Practice, Good Documentation Practices, ICH E6(R2), and ALCOA+ standards.
- Ability to build constructive, positive, collaborative relationships.
- Demonstrated project management experience.
- Advanced proficiency in MS Office Suite and ability to quickly learn new electronic applications.
- Must be authorized to work in the United States.
Nice To Haves
- Life sciences degree or equivalent educational background.
Responsibilities
- Plan, prepare, write, edit, format, and finalize clinical and regulatory documents, including clinical protocols, clinical study reports, Investigator’s brochures, Module 2 registration dossier summaries, annual regulatory submission updates, briefing books, and regulatory responses.
- Provide product and platform writing and strategy support to cross-functional teams.
- Represent Medical Writing on project teams, advise on document content and format requirements, and coordinate document development activities, timelines, and review and revision responsibilities.
- Lead execution of medical writing documents, ensuring adherence to medical writing processes and applicable global regulations.
- Collaborate cross-functionally to promote best practices, implement lessons learned, and improve capabilities for compliant clinical trial execution and real-time inspection readiness.
- Maintain compliance and knowledge of regulations, product areas, current trends, and current literature.
- Create and maintain SOPs and other medical writing governance documents.
- Identify and address compliance or process-efficiency gaps.
- Participate in activities that support cross-functional alignment among electronic document, quality, and TMF systems management.
- Provide medical writing performance metrics and take action to align with corporate, department, and functional goals.
- Participate in Global Regulatory Teams, Clinical Trial Teams, and other sub-teams as needed for assigned products.
- Support development, onboarding, and training for direct reports and the Medical Writing team; mentor colleagues as needed.
- Support corporate objectives with critical impact and align work with organizational business objectives within GRA and cross-functionally.
- Escalate and communicate issues to the supervisor and relevant Medical Writing stakeholders.
Benefits
- Competitive compensation and benefit package.
- Work-life resources and support for physical and emotional wellness, financial wellness, and caregivers.
- Comprehensive benefits; details are available on the company website.
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What This Job Offers
Job Type
Full-time
Career Level
Director
