Remote Medical Writer - CSR & Regulatory Docs

YO AI Labs; San Francisco (CA); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs seeks an experienced Medical Writer/Clinical Document Author to develop, review, and evaluate regulatory documents, ensuring scientific accuracy and regulatory compliance across CSRs, DSURs, and PSURs/PBRERs.

You will interpret clinical protocols, verify source data, and collaborate with cross-functional teams to drive quality. Remote-friendly environment with emphasis on precision and compliance.

Qualifications

• 5+ years of regulatory medical writing experience in sponsor/CRO/consulting environments.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• MD, PharmD, PhD, or MSc 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, 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 initiatives.

Skills

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Written Collaboration

Education

Advanced degree in Life Sciences/Medicine/Pharmacy

Job description

YO AI Labs seeks an experienced Medical Writer/Clinical Document Author to develop, review, and evaluate regulatory documents, ensuring scientific accuracy and regulatory compliance across CSRs, DSURs, and PSURs/PBRERs.

You will interpret clinical protocols, verify source data, and collaborate with cross-functional teams to drive quality. Remote-friendly environment with emphasis on precision and compliance.