Remote Medical Writer — CSR & Regulatory Documents

YO AI Labs; Illinois; Remote; 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 while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing. The role emphasizes CSR authoring, ICH guideline compliance, and eCTD knowledge, with collaboration across cross-functional teams.

This remote contractor position offers competitive hourly pay and opportunities to contribute to AI-assisted documentation

Qualifications

• 5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.

Responsibilities

• Author and review Clinical Study Reports (CSRs) and other regulatory documents.

Skills

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

eCTD Knowledge

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

Strong Written Communication

Cross-functional Collaboration

Education

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

Tools

eCTD Systems

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 emphasizes CSR authoring, ICH guideline compliance, and eCTD knowledge, with collaboration across cross-functional teams.

This remote contractor position offers competitive hourly pay and opportunities to contribute to AI-assisted documentation