Medical Writer for Regulatory CSR and AI Tool Training
Overview
Remote contractor role shaping AI-assisted clinical writing tools through real-world input. You’ll author and review regulatory documents such as Clinical Study Reports, DSURs, and PSURs to train AI systems. Your domain expertise drives how models learn and reason about clinical content, with emphasis on accuracy and structure. Expect to work with ICH E3 guidelines, eCTD placement, and TFL analysis to guide model behavior. Oncology and haematology experience adds value on multiple projects.
What You'll Do6
- 1Author and critique realistic evaluation tasks drawn from Clinical Study Reports, DSURs, PSURs and related clinical documents to guide AI tool development
- 2Judge AI-generated content for compliance with clinical templates and structural requirements, including ICH E3 organization, section order, cross-referencing, and appendix handling
- 3Assess scientific accuracy in sections covering efficacy, safety summaries, discussion, and conclusions, distinguishing factual errors from stylistic differences
- 4Trace narrative claims to source records such as tables, figures, listings, and protocols to verify support for assertions
- 5Provide clear, structured rationales for each assessment to help improve AI model behavior
- 6Collaborate with project leads to refine evaluation frameworks and capture best practices for regulatory writing in AI contexts
Requirements7
- 1Minimum 5 years of regulatory medical writing experience with a sponsor, CRO, or as an independent consultant
- 2Direct experience authoring or leading full Clinical Study Reports rather than only summaries or partial work
- 3Fluency with ICH E3 and knowledge of periodic safety documents (ICH E2F, ICH E2C) and eCTD placement
- 4Ability to read and interpret Tables, Figures, Listings and protocol documents and identify narrative deviations from source data
- 5Exceptional written and verbal communication skills with the ability to give structured, actionable feedback
- 6Advanced degree in life sciences, pharmacy or medicine (PhD, PharmD, MD, MSc) or equivalent authoring depth
- 7Experience across multiple clinical phases; oncology and haematology expertise is highly valued
Who Should Apply
The ideal candidate is a senior medical writer with hands-on experience drafting full Clinical Study Reports and navigating ICH E3 guidelines. You should bring a strong track record in regulatory writing for sponsors or CROs and comfort interpreting TFLs and protocols. This role is less suitable for someone without experience in full CSR authoring or those lacking oncology, hematology, or eCTD knowledge. Common fit issues include limited exposure to ICH E3 structures or absence of experience in eCTD filing, and candidates who cannot demonstrate clear, structured feedback on clinical content.
Salary Insight
Pay range is $50-$80 per hour; pay details are discussed later in the hiring process.
Location
Required Skills
Application Tip
Highlight a completed CSR project and quantify impact, then demonstrate familiarity with ICH E3 structure and eCTD placement in your resume or portfolio.
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How your application is processed
1Application received
Your resume and details are logged the moment you apply.
2ATS + eligibility screening
We check your profile against the role’s skills, seniority, and requirements.
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