Medical Writer / Reviewer

Title : Medical Writer

Location : UK / Poland (Not open for other locations)

Experience Level : 3 Years

Description

1. :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 document
2. s.Comprehensive content QC of clinical data/report
3. s.Documentation of QC findings in the appropriate manner/ to
4. olContent QC activity is applicable for all therapeutic areas, development phases, modalities and geographic region
5. s.Checking of data presented in text and tables/figures against source documents for consistency and accurac
6. y.100% verification of the data/content including text, tables, and figure as per the source document
7. s.Review for grammar, punctuation, spelling and compliance with Client’s styles/standard
8. s.Maintenance of the QC records and checklist

s….