Remote Regulatory Medical Writer – CSR & ICH Expert

YO AI Labs; Seattle (WA); 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, ensuring scientific accuracy and regulatory compliance for sponsor projects.

This remote contractor role focuses on CSR authoring, protocol interpretation, TFL analysis, and eCTD submission readiness, with strong attention to data verification and cross-functional collaboration.

Qualifications

• 5+ years of regulatory medical writing experience in sponsor, CRO, or consulting environments.
• 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, tables, figures, 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

Source Data Verification

eCTD Knowledge

Clinical Protocol Interpretation

TFL Analysis

Written Communication

Education

Advanced degree in Life Sciences

Job description

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

This remote contractor role focuses on CSR authoring, protocol interpretation, TFL analysis, and eCTD submission readiness, with strong attention to data verification and cross-functional collaboration.