Remote Medical Writer - CSR & Regulatory Expert

YO AI Labs; Boston (MA); Remote; USD 69.000 - 110.000; Vollzeit

Zusammenfassung

YO AI Labs seeks an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents ensuring scientific accuracy and regulatory compliance. This remote contractor role focuses on high-quality medical writing for regulatory submissions.

The candidate will interpret protocols, verify data, and support cross-functional teams, including AI-assisted documentation initiatives and quality improvements.

Qualifikationen

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

Aufgaben

• Author and review Clinical Study Reports (CSRs) and other regulatory documents.

Kenntnisse

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Written Communication

Ausbildung

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field

Jobbeschreibung

YO AI Labs seeks an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents ensuring scientific accuracy and regulatory compliance. This remote contractor role focuses on high-quality medical writing for regulatory submissions.

The candidate will interpret protocols, verify data, and support cross-functional teams, including AI-assisted documentation initiatives and quality improvements.