Remote Regulatory Medical Writer - CSR & ICH Expert

YO AI Labs; Chicago (IL); On-site; USD 69,000 - 110,000; Full time

Job summary

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents ensuring accuracy and compliance.

You will author CSRs and regulatory documents, interpret protocols per ICH guidance, verify data, and contribute to AI-assisted documentation quality improvements. This contract role offers remote work with collaboration across global teams.

Qualifications

• 5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• Oncology and haematology experience preferred.

Responsibilities

• Author and review Clinical Study Reports (CSRs) and other regulatory documents.
• Interpret clinical protocols and ensure compliance with ICH guidelines.
• Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation.
• Review safety documentation, including DSURs and PSURs/PBRERs.
• Provide structured feedback and collaborate with cross-functional teams.
• Support AI-assisted documentation evaluation and quality improvement initiatives.

Skills

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Strong Written Communication & Collab

Education

Advanced degree in Life Sciences/Pharmacy/Medicine/Related Field

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents ensuring accuracy and compliance.

You will author CSRs and regulatory documents, interpret protocols per ICH guidance, verify data, and contribute to AI-assisted documentation quality improvements. This contract role offers remote work with collaboration across global teams.