Remote Associate Director, Medical Writing

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

Job summary

Sarepta Therapeutics is seeking an Associate Director of Medical Writing for a fully remote US-based role. You will independently plan, develop, and deliver high-quality regulatory documents, leading MW strategy and cross-functional writing activities with clinical teams and regulatory affairs.

The role requires strong scientific, interpretive, organizational, and project-management skills, plus significant experience in FDA/ICH guidelines and eCTD submissions.

Qualifications

• 10+ years of medical writing or related experience.
• Experience with regulatory documents and eCTD drug submissions.
• Strong ability to interpret clinical data and communicate clearly.

Responsibilities

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents.
• Provide writing strategy support to cross-functional teams and coordinate timelines.
• Ensure MW processes comply with global regulations and internal guidelines.
• Mentor colleagues and support onboarding and training for direct reports.
• Maintain SOPs and MW governance documents and drive process improvements.

Skills

Medical writing

Regulatory writing

Cross-functional collaboration

Project management

Attention to detail

Education

Bachelor's degree in life sciences

Job description

Sarepta Therapeutics is seeking an Associate Director of Medical Writing for a fully remote US-based role. You will independently plan, develop, and deliver high-quality regulatory documents, leading MW strategy and cross-functional writing activities with clinical teams and regulatory affairs.

The role requires strong scientific, interpretive, organizational, and project-management skills, plus significant experience in FDA/ICH guidelines and eCTD submissions.