Remote Medical Writer: CSR & Regulatory Docs Expert

YO AI Labs; Chicago (IL); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.

The role will involve authoring CSRs, interpreting protocols, and ensuring adherence to ICH E3 and eCTD standards, with collaboration across cross-functional teams in a remote contractor capacity.

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.

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, 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

TFL Analysis

eCTD Knowledge

Strong Written Communication

Collaboration

Source Data Verification

Education

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD, MSc)

5+ years of regulatory medical writing in sponsor/CRO/consulting

Tools

eCTD Software

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.

The role will involve authoring CSRs, interpreting protocols, and ensuring adherence to ICH E3 and eCTD standards, with collaboration across cross-functional teams in a remote contractor capacity.