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Title : Medical WriterLocation : UK / Poland (Not open for other locations)Experience Level : 3 YearsDescription: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/ toolContent 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.