• Submission Specialist

    Job ID
    2019-17310
    Location
    US-NY-New York
    Category
    Creative Services
    Company
    TBWA\WorldHealth
  • Overview

     

    tbwa-worldhealth logo

     

    Title: Submission Specialist

     

     Department/Discipline: MLR

     

    Responsibilities:

    • Under supervision of content experts, assist in preparation of the content of submissions to regulatory review teams
    • Manage submission process for electronic submissions, including: 
      • Tracking of new information/documents to be submitted and status of processing
      • Supervising the preparation of documents for electronic submission (e.g., conversion to pdf, addition of bookmarks and hyperlinks). 
      • Performing QC of submission components prepared by team prior to submission
      • Executing electronic filing for medical/legal/regulatory submissions
      • Compiling regulatory compliant submissions in the required formats 
      • Stay current with new electronic submission and regulatory documentation practices
      • Manage multiple submissions and deadlines
      • Maintain accurate documentation
      • Perform related duties as required 

    Qualifications & Experience:

    • Bachelor’s degree
    • 2-4 years’ experience in the pharmaceutical/agency industry
    • Excellent written and verbal skills, with the ability to listen, articulate, and advocate
    • Ability to identify compliance risks and escalate when necessary
    • Experience with pharmaceutical promotions submission process (Veeva) is preferred
    • Exhibit positive, constructive, decisive demeanor

     

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