Medical Writer / Clinical Document Author | $50-$80/hr Remote
Overview
A remote contractor role for an experienced Medical Writer who specializes in regulatory clinical documentation. You’ll contribute to AI-assisted writing tools by producing high quality, real world input from Clinical Study Reports, DSURs, PSURs and related materials, ensuring accuracy and structure align with ICH guidelines. Your domain expertise in oncology and hematology helps train AI to reason and generate precise regulatory content.
What You'll Do6
- 1Create and review realistic evaluation tasks drawn from Clinical Study Reports and related documents to guide AI tool development
- 2Judge AI output for adherence to clinical templates, proper ICH E3 structure, section order, cross references, and appendix management
- 3Assess scientific accuracy in narratives such as efficacy and safety summaries, distinguishing factual errors from stylistic differences
- 4Trace claims back to source data including tables, figures, listings and protocols to verify support for statements
- 5Provide clear, structured rationales for assessments to guide AI model improvements and diagnostic clarity
- 6Collaborate with project leads to refine evaluation criteria and document best practices for AI-assisted clinical regulatory writing
Requirements7
- 1Minimum of 5 years in regulatory medical writing for sponsors, CROs, or independent consulting
- 2Proven track record of independently authoring or leading full Clinical Study Reports
- 3Fluency with ICH E3 standards and related safety documentation (ICH E2F, ICH E2C) and eCTD placement
- 4Ability to interpret tables, figures and protocols and map narrative content to source data
- 5Exceptional written and verbal communication skills with a knack for providing structured, actionable feedback
- 6Advanced degree in life sciences, pharmacy, medicine, or equivalent authoring experience
- 7Experience across multiple clinical phases with emphasis on oncology and hematology
Who Should Apply
Ideal candidates are senior medical writers who specialize in regulatory documentation and want to shape AI tools using real world clinical data. You should be comfortable interpreting complex study materials, ensuring regulatory accuracy, and communicating clear feedback to improve AI systems. A background in oncology or hematology is a strong plus.
Salary Insight
Contract role with an hourly rate in the range of $50-$80 per hour, remote arrangement.
Location
Required Skills
Application Tip
Prepare a concise sample snippet demonstrating how you would verify a safety narrative against source data, including a brief rationale and identified gaps to showcase your skepticism and attention to detail.
Similar open positions
Explore active roles that match your skills and interests.
YO AI Labs
VerifiedMedical Writer Clinical Document Author Remote
We seek an experienced Medical Writer to develop review and evaluate clinical regulatory documents ensuring scientific accuracy and compliance. This remote contractor role focuses on authoring CSRs and supporting AI-driven documentation evaluation.
YO AI Labs
VerifiedMedical Writer Clinical Document Author Remote
We seek an experienced Medical Writer / Clinical Document Author to develop review and evaluate clinical regulatory documents while ensuring scientific accuracy regulatory compliance and high-quality medical writing. This role involves authoring Clinical Study Reports and supporting AI-assisted documentation evaluation and quality improvement initiatives.
YO AI Labs
VerifiedMedical Writer, Clinical Documents & Regulatory Affairs
You'll author and review Clinical Study Reports (CSRs) and regulatory documents for a remote-first clinical research team. You'll ensure scientific accuracy and compliance with ICH E3 guidelines while supporting AI-assisted documentation evaluation. Your work directly shapes submissions that reach global regulators. This role offers flexible remote work and a contract engagement with competitive pay.
YO AI Labs
VerifiedMedical Writer, Clinical Documents & Regulatory Submissions
Author Clinical Study Reports and regulatory documents for AI-assisted projects. You will own the full authoring cycle, from protocol interpretation to final CSR, ensuring ICH E3 compliance. Work with cross-functional teams in a remote contract role, delivering high-quality outputs. Pay ranges $50–$80/hour based on experience and expertise.
YO AI Labs
VerifiedMedical Writer, Regulatory & Clinical Documents
You will author and review Clinical Study Reports (CSRs) and other regulatory documents for a remote contractor role at YO AI Labs. Work with cross-functional teams to ensure scientific accuracy and compliance with ICH E3, ICH E2F, and ICH E2C. Support AI-assisted documentation evaluation and quality improvement. This role offers the flexibility of remote work and a competitive hourly rate.
YO AI Labs
VerifiedMedical Writer, Clinical Documentation & Regulatory
You will author and review clinical and regulatory documents, including Clinical Study Reports (CSRs) and safety reports, ensuring scientific accuracy and compliance with ICH guidelines. You will work with cross-functional teams and support AI-assisted documentation evaluation. 5+ years of regulatory medical writing experience and strong knowledge of ICH E3, ICH E2F, and ICH E2C are essential. This role offers the chance to shape documentation quality in a remote, contract capacity.