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Clinical Operations-Quality Process Document Manager/Technical Writer

New Jersey All, NJ

Posted: 08/31/2018 Job Type: Clinical Job Number: JN -082018-22447
This is a Clinical role and requires the following:
  • Bachelor degree in a scientific/health-related field
  • 5 years of experience in the pharmaceutical industry
  • 3 years of experience in clinical and/or quality operations-related roles (e.g., direct study management, monitoring, project management)
  • Experience working within a global team/environment to produce operational reference standards to meet regulatory requirements across regions
  • Someone with Clinical Trial experience who has written SOPs or other documents is acceptable
Duties:
  • Interact with process improvement project teams to review/clarify to be processes and obtain additional information to finalize process maps (flowcharts)
  • Develop SOPs, Working Instructions and Supporting Documents templates, checklists, etc.), using corporate templates and writing rules and according to international regulations and Good Clinical Practice ICH guidelines.
  • Manage QD review & approval process, follow up with business representatives and process owners, organize & chair review meetings
  • Revise/update QDs according to decisions made by working group
  • Status reporting & associated administration

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