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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 integral regulatory and clinical documentation projects.
Why Join Freyr
Be part of a growing organization supporting global regulatory and

Postúlate en Kit Empleo: kitempleo.com.co/empleo/1asruv

📌 Medical Writer/Reviewer (Medellín)
🏢 Freyr Solutions
📍 Medellín