Remote Associate Director, Medical Writing

Sarepta Therapeutics; Georgia; 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 is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. The role requires leadership, scientific interpretation, and project management within a global team.

This fully remote US-based position offers a competitive salary range and opportunities to contribute across Duchenne and other disease programs. The role emphasizes adherence to regulatory standards and cross-functional collaboration.

Qualifications

• Bachelor's degree or equivalent; life sciences is preferred.
• 10+ years of relevant experience, with 8+ years of medical writing or other writing experience.
• Excellent writing skills.
• Ability to understand, interpret, and communicate clinical and scientific data.
• Knowledge of drug development process and regulatory requirements for GCP/ICH/eCTD documents.
• NDAs/BLAs experience with active contribution in preparation and writing of clinical and regulatory documents.

Responsibilities

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents.
• Provide product and platform writing and strategy support to cross-functional teams.
• Lead MW processes to ensure compliance with global regulations.
• Collaborate cross-functionally to improve writing practices and inspection readiness.
• Maintain knowledge of regulations and guidelines applicable to MW documents.
• Lead efforts to identify and fix compliance or efficiency gaps in processes.
• Mentor MW team and support onboarding and training.

Skills

Advanced medical writing

Regulatory documents

Project management

Cross-functional collaboration

GCP/ICH knowledge

MS Office

Education

Bachelor's degree or equivalent; life sciences preferred

Job description

Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. The role requires leadership, scientific interpretation, and project management within a global team.

This fully remote US-based position offers a competitive salary range and opportunities to contribute across Duchenne and other disease programs. The role emphasizes adherence to regulatory standards and cross-functional collaboration.