Medical Writer/Reviewer

About Freyr

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 data, to achieve the highest quality from a technical, regulatory, and compliance perspective. Verify internal consistency within a document and across related documents.
• Comprehensive content QC of clinical data/reports.
• Documentation of QC findings in the appropriate manner/ tool
• Content QC activity is applicable for all therapeutic areas, development phases, modalities and geographic regions.
• Checking of data presented in text and tables/figures against source documents for consistency and accuracy.
• 100% verification of the data/content including text, tables, and figure as per the source documents.
• Review for grammar, punctuation, spelling and compliance with Client's styles/standards.
• Maintenance of the QC records and checklists.

Qualifications & Experience

Education: Bachelor’s degree in Life Sciences or related field.

Experience: 3 Years

What We Offer

Competitive compensation and opportunity to work on global regulatory and clinical documentation projects.

Why Join Freyr

Be part of a growing organization supporting global regulatory and clinical writing excellence.