Remote Associate Director, Medical Writing & Regulatory Docs

Sarepta Therapeutics; Connecticut; Híbrido; USD 161 000 - 201 000; Tempo integral

Resumo da oferta

Sarepta Therapeutics is seeking an Associate Director of Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. You will lead writing strategy, coordinate cross-functional teams, and ensure regulatory compliance across global submissions.

This is a fully remote US-based role with hybrid availability; the salary range is disclosed and compensation reflects experience, complexity, and alignment with Sarepta's guidelines.

Qualificações

• Bachelor's degree in life sciences or equivalent is required.
• 10+ years of relevant experience with 8+ years in medical writing or related writing.
• Strong writing and editing skills with attention to regulatory requirements (GCP/ICH/eCTD).
• Experience with NDAs/BLAs and regulatory submissions is desirable.

Responsabilidades

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents (protocols, CSR, IFU, submission modules).
• Provide writing strategy to cross-functional teams and coordinate document development timelines.
• Ensure MW documents comply with internal processes and global regulations.
• Mentor and train MW team members; support onboarding and training.

Conhecimentos

Excellent writing skills

Clinical/scientific data comprehension

Regulatory document knowledge

Project management

Cross-functional collaboration

Formação académica

Bachelor's degree or equivalent; life sciences preferred

Descrição da oferta de emprego

Sarepta Therapeutics is seeking an Associate Director of Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. You will lead writing strategy, coordinate cross-functional teams, and ensure regulatory compliance across global submissions.

This is a fully remote US-based role with hybrid availability; the salary range is disclosed and compensation reflects experience, complexity, and alignment with Sarepta's guidelines.