Administrative Assistant, Regulatory & HR (Temporary)

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Regulatory Responsibilities

  • Provide daily administrative support for the Vice President, Regulatory Affairs including calendar management, presentation development, document and file management, travel, expense management, etc.
  • Play an integral role in the planning, logistics and materials management for off-site meetings
  • Active participation in some Regulatory Affairs initiatives and projects
  • In-house support for 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 clients expectations
  • Provide administrative and operational support to Regulatory Affairs departmental across programs:
    • Coordinate with Pharmacovigilance and Regulatory Operations departments and execute the submission of product safety information to FDA
    • Catalog regulatory agency correspondence into clients Regulatory Information Management system
  • Prepare routine submissions to FDA

Human Resources Responsibilities

  • Provide daily administrative support for the Sr. Vice President, Human Resources including calendar management, presentation development, document and file management, travel, expense management, etc.
  • Play an integral role in the planning, logistics and materials management for off-site meetings
  • Support on-site HR related events and informational/education sessions
  • Active participation in some Human Resource initiatives and projects
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