Remote Associate Director, Medical Writing — Lead Docs

Sarepta Therapeutics; Cambridge (MA); 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 for our pipeline in Duchenne and beyond. This fully remote US-based role requires strategic writing leadership and strong cross-functional collaboration.

You will oversee documents such as protocols, study reports, investigator brochures, and regulatory submissions, ensuring accuracy, regulatory compliance, and timely delivery while

Qualifications

• Bachelor’s degree in life sciences; advanced degree preferred.
• 10+ years of relevant experience, with 8+ years in medical writing.
• Excellent writing skills and ability to interpret clinical data.
• Knowledge of drug development process and regulatory requirements (GCP/ICH/eCTD).
• Experience with NDAs/BLAs and clinical/regulatory document preparation.
• Strong multitasking and ability to lead cross-functional teams under tight timelines.
• Proven project management and collaborative skills.

Responsibilities

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents.
• Develop documents such as clinical protocols, study reports, Investigator’s brochures, and regulatory submissions.
• Provide MW strategy and writing support to cross-functional teams.
• Lead writing activities, coordinating timelines and review responsibilities.
• Ensure MW processes compliance and inspection readiness.
• Mentor colleagues and participate in cross-functional alignment across teams.
• Maintain knowledge of regulations and current literature.

Skills

Medical writing

Regulatory writing

Project management

Cross-functional teamwork

Communication skills

MS Office

GCP/ICH knowledge

Attention to detail

Education

Bachelor’s degree in life sciences

Tools

Electronic document management systems

Job description

Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents for our pipeline in Duchenne and beyond. This fully remote US-based role requires strategic writing leadership and strong cross-functional collaboration.

You will oversee documents such as protocols, study reports, investigator brochures, and regulatory submissions, ensuring accuracy, regulatory compliance, and timely delivery while