Remote Associate Director, Medical Writing

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

Benefits offered by this job

Physical & Emotional Wellness

Financial Wellness

Caregiver Support

Job summary

Sarepta Therapeutics, a leader in genetic medicine, seeks an Associate Director, Medical Writing for a fully remote role in the United States. You will independently plan, develop, and deliver high-quality clinical and regulatory documents, guiding MW strategy and coordinating cross-functional teams to ensure regulatory compliance.

The role requires 10+ years in medical writing, strong writing skills, and knowledge of GCP/ICH/eCTD guidelines.

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 interpret clinical data.
• Knowledge of drug development and regulatory guidelines (GCP/ICH/eCTD).
• Experience with NDAs/BLAs and regulatory documents.
• Strong multitasking and timeline-management abilities.
• Experience with cross-functional teams and project governance.
• Proficiency in MS Office and adaptability to new tools.

Responsibilities

• Plan, draft, edit, format, and finalize clinical/regulatory documents (protocols, summaries, dossiers, annual updates, regulatory responses).
• Provide writing and strategy support to cross-functional teams; coordinate timelines and review responsibilities.
• Ensure MW documents meet regulatory standards and company processes.
• Collaborate to improve MW practices and inspection readiness.
• Maintain regulatory knowledge and SOPs; mentor MW staff and support onboarding.
• Deliver metrics on performance and align with department goals.

Skills

Medical writing

Regulatory documents

Project management

Cross-functional collaboration

GCP/ICH/eCTD knowledge

Education

Bachelor's degree in life sciences

Tools

MS Office

Job description

Sarepta Therapeutics, a leader in genetic medicine, seeks an Associate Director, Medical Writing for a fully remote role in the United States. You will independently plan, develop, and deliver high-quality clinical and regulatory documents, guiding MW strategy and coordinating cross-functional teams to ensure regulatory compliance.

The role requires 10+ years in medical writing, strong writing skills, and knowledge of GCP/ICH/eCTD guidelines.