Remote Associate Director, Medical Writing

Sarepta Therapeutics; Washington (District of Columbia); Teletrabalho; USD 161 000 - 201 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Resumo da oferta

Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents. You will ensure scientific accuracy, clarity, and adherence to regulatory guidelines while providing leadership and strategy for MW planning.

Remote US-based role with hybrid possibilities; strong project management and cross-functional collaboration are essential to drive compliant trial documentation and inspection readiness.

Qualificações

• Bachelor's degree or equivalent; life sciences preferred.
• 10+ years of relevant experience, with 8+ years in medical writing.
• Excellent writing skills and ability to interpret clinical data.
• Knowledge of drug development processes and regulatory guidelines.
• Experience with NDAs/BLAs and clinical/regulatory documents.

Responsabilidades

• Plan, prepare, write, edit, format, and finalize clinical/regulatory documents.
• Provide writing strategy support to cross-functional teams and manage timelines.
• Ensure MW processes and regulatory compliance across documents.
• Collaborate to improve practices and inspection readiness.
• Mentor colleagues and support training for direct reports.

Conhecimentos

Excellent writing skills

Interpret clinical data

Regulatory knowledge

Cross-functional collaboration

Project management

Ability to multitask

Formação académica

Bachelor's degree or equivalent

Life sciences preferred

Ferramentas

MS Office Suite

Descrição da oferta de emprego

Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents. You will ensure scientific accuracy, clarity, and adherence to regulatory guidelines while providing leadership and strategy for MW planning.

Remote US-based role with hybrid possibilities; strong project management and cross-functional collaboration are essential to drive compliant trial documentation and inspection readiness.