Medical Writer/Reviewer

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...