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East Hanover

    Senior Project Manager- Brand Marketing - East Hanover, United States - JSR Tech Consulting

    JSR Tech Consulting
    JSR Tech Consulting East Hanover, United States

    1 week ago

    Default job background
    Description
    Initial responsibility will be to organize and assist the IgAN team and

    Client DRA with Subpart H submission of IgAN materials.

    Create a reference list (across all workstreams) of the materials brand

    will need "in market for the first 121 days post-launch.

    In preparation for when 2253 process is initiated, prioritize materials list

    to ensure brand's key materials will be included in the initial batches

    submitted to OPDP (websites, patient support materials, sales materials,

    medical information, etc.)

    • Develop timelines, materials, and communications that will track
    according to DRA timelines (from FUSE approval/release to

    appropriate Subpart H batch).

    • In partnership with DRA, create reference materials, and
    conduct training for internal and external agencies/partners

    providing guidance for the submission of their content via

    Subpart H (timing if batch submissions, required annotations,

    etc.)

    Support

    Client Atrasentan Launch Team Lead:

    • Organize and spearhead Launch Readiness Meetings for IgAN
    launch.

    • Schedule LMT meetings including all relevant workstreams.
    • Develop meeting agendas & facilitate meeting discussions.
    • Provide documentation/minutes.
    Help identify and mitigate identified risks that could potentially

    impact launch.

    • Develop timelines & finalize Day 1 Plan for the launch.
    • Utilize knowledge and experience obtained when managing
    IgAN SubpartH submissions to OPDP and apply this model to spearhead

    the SubpartH submissions for IgAN

    #LI-JV1
    #J-18808-Ljbffr


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