Remote Associate Director, Medical Writing

Sarepta Therapeutics; Rhode Island; Remote; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents. You will provide leadership and subject-matter expertise for MW strategy, coordinate timelines, and ensure adherence to regulatory guidelines.

This fully remote US-based role requires strong scientific, interpretive, and project management skills, with the ability to lead cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor’s degree in life sciences or equivalent.
• 10+ years of medical writing or related experience.
• Excellent writing skills and ability to interpret clinical data.
• Knowledge of regulatory requirements and GxP guidelines (GCP/ICH/eCTD).
• Experience with NDA/BLA documents and regulatory submissions.

Responsibilities

• Plan, write, edit, format, and finalize clinical/regulatory documents.
• Provide writing strategy support to cross-functional teams.
• Lead MW processes to ensure compliance with global regulations.
• Collaborate to improve MW capabilities and inspection readiness.
• Mentor colleagues and support training for direct reports.

Skills

Medical Writing

Regulatory Writing

Cross-functional teamwork

Project Management

Education

BSc Life Sciences

Tools

MS Office

Job description

Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents. You will provide leadership and subject-matter expertise for MW strategy, coordinate timelines, and ensure adherence to regulatory guidelines.

This fully remote US-based role requires strong scientific, interpretive, and project management skills, with the ability to lead cross-functional teams in a fast-paced environment.