Pharmaceutical

Pharmaceutical

  • Developed and delivered systems training for Document Management Systems, eCTD Systems, and MS Word Template Programs.
  • Developed instructor led and online learning programs.
  • Work with the following subject matter :
    Drug Development
    FDA Requirements
    Overview of Clinical Trials
    Clinical Trial Application
    Labeling
    Managing PSUR Assessment Reports
    Regulatory Operating Models
  • Assisted in the development of many courses related to Regulatory Compliance.
  • Assisted in Training Management Long Range Plans, working with vendors, scheduling vendors and overseeing the management of Regulatory Training.