Remote Regulatory Medical Writer (CSR & eCTD Expert)

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 Expert to work remotely on regulatory documentation. You will develop, review, and evaluate clinical and regulatory manuscripts, CSR authoring, and ensure scientific accuracy and regulatory compliance.

You will interpret protocols, verify data with source documents, review safety reports, and support AI-assisted quality improvement initiatives while collaborating with cross-functional teams.

Qualifications

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

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

Written Communication & Collaboration

Education

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

Job description

YO AI Labs is seeking an experienced Medical Writer Expert to work remotely on regulatory documentation. You will develop, review, and evaluate clinical and regulatory manuscripts, CSR authoring, and ensure scientific accuracy and regulatory compliance.

You will interpret protocols, verify data with source documents, review safety reports, and support AI-assisted quality improvement initiatives while collaborating with cross-functional teams.