Remote Associate Director, Medical Writing

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

Job summary

Sarepta Therapeutics, based in the United States, seeks an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents. You will lead writing strategies, coordinate cross-functional teams, and ensure regulatory compliance across programs.

The role requires strong writing skills, deep regulatory knowledge, and the ability to mentor staff while maintaining timeline commitments and inspection readiness.

Qualifications

• Bachelor's degree in life sciences or equivalent.
• 10+ years of relevant experience, with 8+ years in medical writing.
• Excellent writing skills and ability to communicate clinical data clearly.
• Knowledge of drug development and regulatory requirements (GCP/ICH/eCTD).
• Experience with NDA/BLAs and contributing to regulatory documents.

Responsibilities

• Plan, write, edit, format, and finalize clinical and regulatory documents (protocols, study reports, Investigator's Brochures, etc.).
• Provide writing strategy to cross-functional teams and coordinate timelines and reviews.
• Lead MW processes to ensure compliance and quality in documentation.
• Mentor MW staff and support training and onboarding of team members.
• Ensure alignment with regulatory requirements and company objectives.

Skills

Excellent writing

Data interpretation

Regulatory knowledge

Project management

Cross-functional

NDA/BLA experience

Multitasking

Communication skills

Adaptability

Education

Bachelor's degree life sciences

Tools

MS Office Suite

Job description

Sarepta Therapeutics, based in the United States, seeks an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents. You will lead writing strategies, coordinate cross-functional teams, and ensure regulatory compliance across programs.

The role requires strong writing skills, deep regulatory knowledge, and the ability to mentor staff while maintaining timeline commitments and inspection readiness.