Medical Reviewer - Clinical QC

Freyr is a fast‑growing, innovative company specializing in providing end‑to‑end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device and biotech companies in navigating regulatory compliance.

Reviewer – Clinical QC

United Kingdom

1 year fixed term employment

• Comprehensive QC review of clinical sections of regulatory documents, including but not limited to: IBs, 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.
• Verification of the data/content (100%) including text, tables, and figures as per the source documents.
• Review for grammar, punctuation, spelling and compliance with specified styles/standards.
• Maintenance of the QC records and checklists.