Part Time Administrative Assistant

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Our client is looking for a part-time administrative Assistant to work 25 hours a week, preferably from 1-5pm Monday through Friday. This assistant will be reporting to the VP of Regulatory and supporting Regulatory function and NDA team. This will be a temporary assignment lasting about 12 months.

Life sciences (hospital, academic center, or university) experience a plus!

Description:

In-house support for Avapritinib Regulatory Affairs team and designees, including but not limited to:

  • Centralized support of NDA submission-related team activities
  • Scheduling NDA related team meetings (internal meetings and those with external vendors/contractors), workshops, offsites, etc
  • Avapritinib NDA submission calendar management
  • Meeting planning and set up
  • Coordinating meeting attendee availability
  • Support cross-functional avapritinib submission-related teams:
  • Procure lunches / snacks for submission specific meetings
  • Manage submission team contact lists, distribution lists, and other supporting documents enabling greater team effectiveness
  • Follow up with external vendors to ensure alignment with client expectations

Schedule and book submission-related travel for team:

  • Book travel, lodging and coordinate logistics for offsites meetings
  • Print/ship meeting specific materials, as needed

Provide administrative and operational support to Regulatory Affairs departmental across programs:

  • Coordinate with Client and Regulatory Operations departments and execute the submission of product safety information to FDA
  • Catalog regulatory agency correspondence into client Regulatory Information Management system
  • Prepare routine submissions to FDA
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