Job Description
Freyr is a leading Regulatory Solutions and Services company supporting global Life Sciences organizations across Regulatory Affairs, Pharmacovigilance, Quality, and Compliance.
Job Title: Medical Writer
Location: Colombia - Remote
Employment Type: Full-Time / Contract
Role Overview
Support quality control (QC) review of clinical and regulatory documents, ensuring accuracy, consistency, and compliance with regulatory and client standards.
Key/Primary Responsibilities
- Comprehensive QC review of clinical sections of regulatory documents, including but not limited to, IBs, CSRs, Module 2 & 5, Narratives, Protocols, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), briefing packages for regulatory agency meetings/advice, including verification of all references and source...