Associate Director, Medical Writing

Sarepta Therapeutics•Cambridge, MA

3d•Hybrid

About The Position

The Associate Director, Medical Writing independently plans, develops, and delivers high-quality, strategically aligned clinical and regulatory documents. The role ensures scientific content, organization, clarity, accuracy, adequacy, format, and consistency, as well as compliance with regulatory and internal guidelines, styles, and processes. It provides medical-writing leadership, subject-matter expertise, and strategy for planning and coordination. The position works closely with clinical, regulatory, and cross-functional teams and requires strong scientific, interpretive, organizational, and project-management skills. The posting describes the role as fully remote and U.S.-based, while also stating that the position is hybrid, with on-site work at a Sarepta facility and/or attendance at company-sponsored in-person events from time to time. The targeted salary range is $160,800–$201,000 per year. Candidates must be authorized to work in the U.S.

Requirements

Bachelor’s degree or equivalent; life sciences is preferred.
10+ years of relevant experience, including 8+ 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/eCTD-compliant documents.
Previous NDA/BLA experience, with active contribution to the 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 U.S.

Nice To Haves

A life sciences degree is preferred.

Responsibilities

Plan, prepare, write, edit, format, and finalize clinical and regulatory documents, including clinical protocols, clinical study reports, Investigator’s brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, and regulatory responses.
Provide product and platform writing and strategy support to cross-functional teams.
Represent Medical Writing on project teams; advise teams on document content and format requirements, and coordinate document-development writing 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, apply 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 efficiency gaps in processes.
Participate in meetings and activities that enhance cross-functional alignment among electronic document, quality, and TMF systems management.
Provide medical-writing performance metrics and take action to support corporate, department, and functional goals.
Participate in the Global Regulatory Team, Clinical Trial Team, and other subteams 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 effectively communicate issues to the supervisor and relevant medical-writing stakeholders.