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Insmed Incorporated Message Board

  • checksurshorts checksurshorts May 1, 2014 1:21 AM Flag

    New Position: Regulatory Associate

    Job Description


    Overall responsibility is to support the North American Regulatory Affairs Sr. Directors/Directors, which includes working with cross-functional teams from Managed Markets, Marketing, Clinical, Medical, and Quality.


    The Regulatory Associate will be responsible for the following:

    Promotional Review Committee
    ◾Supports the Chair in the management of the MLR/PRC process
    ◾Manages the logistics of Materials and Agenda distribution through an online (cloud-based) document management system
    ◾Captures comments/changes to the Materials suggested by the Committee
    ◾Manages and is responsible for the handling, storage, and tracking of Material submission, review, and approval files, including being responsible and accountable for storing material and ensuring that they are accessible after the meeting
    ◾Ensures submission to the FDA of all final Promotional Materials, as required

    Work with the Regulatory Affairs team to compile regulatory documents for submission (annual reports, NDA, etc.)
    ◾Assist in the maintenance of regulatory project logs/databases, tracking the submission status of reports and other regulatory activities
    ◾Upload final regulatory documents to the cloud-based document management system

    Sentiment: Strong Buy

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