Syneos Health UK LimitedHiring

Senior Medical Writer (Regulatory Documents)

  • Remote, United States
  • Senior
  • Posted 13 days ago
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In one line

Write and coordinate regulatory documents such as protocols, clinical study reports and investigator brochures for a dedicated sponsor account, based in North America or EMEA.

About the role

The work covers a wide document set, from patient narratives to submission modules, and needs someone who can run writing activities for individual studies with little supervision.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Senior
Skills
ICH E3, Clinical study reports, Protocols, Investigator brochures, Statistical analysis plans, eCTD
Posted
16 Oct 2026
Last checked
27 Oct 2026

What you will do

  • Draft protocols, amendments, clinical study reports, patient narratives, investigator brochures and consent forms
  • Lead resolution of client comments and coordinate quality and editorial reviews
  • Check statistical analysis plans and table, figure and listing specs for content, grammar and format
  • Peer review team documents for scientific content, clarity and consistency

What they look for

  • Experience writing regulatory documents for clinical studies, including CSRs and protocols
  • Familiarity with ICH E3 and other applicable standards, plus client templates and style guides

Nice to have

  • Background reviewing statistical outputs and providing feedback on needed tables and figures

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Questions about this job

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

Yes, it is listed as remote, aimed at candidates in the United States.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a senior role. The posting asks for: experience writing regulatory documents for clinical studies, including CSRs and protocols; familiarity with ICH E3 and other applicable standards, plus client templates and style guides. Skills it names include ICH E3, Clinical study reports, Protocols, Investigator brochures.

How do I apply with Keywordise AI?

Press the Apply with Keywordise AI button and add your CV. Keywordise tailors your CV and cover letter to this posting and sends the application for you, with a free 7-day trial and no card.

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