Remote Regulatory Medical Writer — CSR & ICH Expert

YO AI Labs; Washington (District of Columbia); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs is seeking an experienced Medical Writer/Clinical Document Author for a remote contracting role. You will develop and review regulatory documents, ensuring scientific accuracy and regulatory compliance across CSRs and related submissions.

Key responsibilities include interpreting clinical protocols, verifying data with TFLs, and collaborating with cross-functional teams. Experience with ICH E3/E2F/E2C and eCTD is essential, with oncology experience being a plus.

Qualifications

• 5+ years of regulatory medical writing experience in Sponsor, CRO, or consulting.
• 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 (Tables, Figures, and Listings), 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 / related (MD, PharmD, PhD, MSc)

Job description

YO AI Labs is seeking an experienced Medical Writer/Clinical Document Author for a remote contracting role. You will develop and review regulatory documents, ensuring scientific accuracy and regulatory compliance across CSRs and related submissions.

Key responsibilities include interpreting clinical protocols, verifying data with TFLs, and collaborating with cross-functional teams. Experience with ICH E3/E2F/E2C and eCTD is essential, with oncology experience being a plus.