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Clinical QA Documentation Manager

Edison-New Brunswick Metro Area, NJ

Posted: 11/08/2018 Job Type: Scientific Job Number: JN -112018-22997
  • Qualifications
  • Bachelor s degree required
  • Minimum of 5 years of clinical quality control, document management and/or clinical publishing experience
  • Thorough knowledge of Good Publications Practices (GPP2) required..
  • Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems necessary,
  • Responsibilities
  • The primary responsibilities of this position are to check the quality of clinical documents including but not limited to, protocols, Investigator Brochures (IBs), clinical study reports (CSRs), and Summary Modules for regulatory submissions. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems.
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