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.