Senior Medical Writing Director — Remote

Sarepta Therapeutics; Denver (CO); Remote; USD 161,000 - 201,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics, a leader in Duchenne Muscular Dystrophy gene therapies, seeks an Associate Director of Medical Writing to plan, write, and finalize regulatory documents with leadership in MW strategy. The role requires deep regulatory knowledge, project management, and cross-team collaboration.

The position is fully remote in the US; targeted salary range is $160,800–$201,000 per year, with a comprehensive compensation package and equal opportunity employment.

Qualifications

• This role requires excellent writing skills and the ability to interpret clinical data.
• Strong project management and cross-functional collaboration skills.
• Understanding of regulatory expectations (GCP/ICH/eCTD).
• Ability to manage multiple documents and timelines.

Responsibilities

• Plan, prepare, write, edit, format and finalize clinical and regulatory documents (protocols, study reports, Investigator's brochures, regulatory Briefing books).
• Provide writing strategy support to cross-functional teams and coordinate document development timelines.
• Ensure MW documents meet regulatory standards and internal processes.
• Collaborate cross-functionally to improve practices and alignment with goals.
• Mentor team members and support onboarding and training.

Skills

Excellent writing skills

Ability to understand and interpret CL

Education

Bachelor's degree or equivalent

Tools

MS Office Suite

Job description

Sarepta Therapeutics, a leader in Duchenne Muscular Dystrophy gene therapies, seeks an Associate Director of Medical Writing to plan, write, and finalize regulatory documents with leadership in MW strategy. The role requires deep regulatory knowledge, project management, and cross-team collaboration.

The position is fully remote in the US; targeted salary range is $160,800–$201,000 per year, with a comprehensive compensation package and equal opportunity employment.