Associate Director, Medical Writing

Responsibilities

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents such as protocols, study reports and regulatory submissions

• Provide product and platform writing and strategy support to cross-functional teams

• Create and maintain SOP and other medical writing governance documents

• Lead efforts to identify and close compliance or efficiency gaps in processes

• Provide metrics on medical writing performance and mentor colleagues

Requirements

• Bachelor's degree or equivalent; life sciences preferred

• 10+ years of relevant experience, including 8+ years of medical or other writing

• Previous NDA/BLA writing experience

• Knowledge of GCP, ICH E6(R2), eCTD and ALCOA+ standards

• Strong project management and multitasking skills

• Advanced proficiency in MS Office Suite

Preferred Qualifications

• Life sciences degree

Benefits

• Physical and emotional wellness, financial wellness and caregiver support

About the Company

Sarepta is a genetic medicine company focused on rare diseases, with a leadership position in Duchenne muscular dystrophy.