Sarepta Therapeutics, Inc.Hiring

Associate Director, Medical Writing

  • Remote, United States
  • Lead
  • Posted 2 weeks ago
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In one line

Senior medical writing role on a clinical team, producing regulatory and clinical documents for gene therapy programmes; fully remote within the US.

About the role

Clinical and regulatory paperwork for a portfolio that spans muscle, nervous system and heart disease programmes. Good work means documents that are accurate, consistent and ready for regulators, plus writing strategy that project teams can rely on.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Skills
Medical Writing, Clinical Study Reports, Regulatory Submissions, Project Management
Posted
20 Oct 2026
Last checked
2 Nov 2026

What you will do

  • Plan, draft, edit and finalise clinical protocols, study reports and investigator brochures
  • Write Module 2 summaries, annual submission updates, briefing books and answers to regulators
  • Represent medical writing on project teams and set timelines and review duties
  • Keep documents compliant with global rules and internal styles and processes
  • Create and maintain SOPs and other medical writing governance documents

What they look for

  • Able to plan and deliver clinical and regulatory documents without close supervision
  • Strong grasp of science and the ability to interpret it for documents
  • Solid organisation and project management across several documents at once
  • Comfortable advising cross-functional teams on content and format needs
  • Works well inside a team and keeps to regulatory and internal guidelines

Benefits

  • Wellness support for body and mind
  • Financial wellness resources
  • Help for people with caregiving duties

A typical week

  • Writing and revising clinical and regulatory documents
  • Meeting project teams to agree content, format and timelines
  • Reviewing drafts and coordinating revisions with colleagues
  • Keeping up with regulations, current literature and product areas
  • Tracking writing performance and fixing process gaps

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Questions about this job

Can I do this job remotely, and from which countries?

Yes. The posting lists Associate Director, Medical Writing as a remote role for candidates in the United States.

What does this job pay?

The posting does not state a salary, so there is no figure to quote.

What experience is needed?

It is a lead role. The posting asks for: able to plan and deliver clinical and regulatory documents without close supervision; strong grasp of science and the ability to interpret it for documents; solid organisation and project management across several documents at once. Skills it names include Medical Writing, Clinical Study Reports, Regulatory Submissions, Project Management.

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Sarepta Therapeutics, Inc.Remote, United States
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