Remote Medical Writer - CSR & Regulatory Docs

YO AI Labs; New York (NY); 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 with a focus on scientific accuracy and regulatory compliance. The role emphasizes high-quality medical writing, CSR authoring, and adherence to ICH guidelines across regulatory submissions.

The successful candidate will interpret clinical protocols, verify source data, and collaborate with cross-functional teams, including AI-assisted documentation

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.
• Advanced degree in Life Sciences or related field.

Responsibilities

• Author and review CSRs and other regulatory documents.
• Interpret clinical protocols and ensure ICH guideline compliance.
• 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

Source Data Verification

eCTD Knowledge

Clinical Protocol Interpretation

TFL Analysis

Strong Written Communication

Education

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

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents with a focus on scientific accuracy and regulatory compliance. The role emphasizes high-quality medical writing, CSR authoring, and adherence to ICH guidelines across regulatory submissions.

The successful candidate will interpret clinical protocols, verify source data, and collaborate with cross-functional teams, including AI-assisted documentation