Title : Medical Writer

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

Experience Level : 3 Years

Description

• :
  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
• s.Comprehensive content QC of clinical data/report
• s.Documentation of QC findings in the appropriate manner/ to
• olContent QC activity is applicable for all therap...