Remote Medical Writer: CSR & Regulatory Documentation Expert

YO AI Labs; Houston (TX); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with scientific accuracy. The role emphasizes adherence to ICH guidelines and eCTD knowledge, with collaboration across cross-functional teams.

Remote contractor position offering $50–$80/hour. Candidates should have 5+ years in regulatory medical writing and experience with CSR authoring and clinical study documentation.

Qualifications

• Minimum 5+ years of regulatory medical writing experience in sponsorship, CRO, or consulting settings.
• 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

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Strong Written Communication

Education

Advanced degree in Life Sciences/Pharmacy/Medicine (MD/PharmD/PhD/MSc)

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with scientific accuracy. The role emphasizes adherence to ICH guidelines and eCTD knowledge, with collaboration across cross-functional teams.

Remote contractor position offering $50–$80/hour. Candidates should have 5+ years in regulatory medical writing and experience with CSR authoring and clinical study documentation.