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Manager, Promotional Review

New York, New York

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a Manager, Promotional Review to oversee and lead the end-to-end management of all aspects of the commercial advertising and promotional review process for Axsome. This individual will serve as the primary contact in the management of all aspects of the advertising and promotional review process and work closely as a strategic partner with the Commercial, Regulatory, Legal, Compliance, Medical and Marketing Operations teams. Responsibilities include creating and managing agendas, identifying best practices, guiding short- and long-term planning, and improving processes and efficiencies. Reporting to the Senior Director, Corporate and Commercial Counsel, the Manager, Promotional Review will be a critical member of the Promotional Review Committee (PRC) and partner to the review and approval process. 

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.  

Job Responsibilities and Duties include, but are not limited to, the following:

  • Collaborate cross-functionally with Regulatory, Medical, Legal, Marketing, Commercial, Compliance and Agencies
  • Lead the coordination of the promotional review committee activities and ensure that the promotional review process is conducted both in a highly compliant manner and in a timely and efficient manner
  • Lead and manage the end-to-end review, approval and expiration lifecycle of promotional materials in Veeva Vault PromoMats
  • Facilitate, lead and manage high quality PRC meetings, including leading the review of materials, planning agendas and content, ensuring meeting documents are routed to PRC review team prior to meetings, and performing operational tasks such as annotating and accurately capturing comments during live reviews, and performing the final proofing of materials are complete before proceeding to an approved status
  • Review and ensure that all material submissions are complete and meet certain quality standards prior to circulation to reviewers and provide proactive guidance to sponsors on submission of high quality and compliant work  
  • Create and manage the weekly Planning & Prioritization forecast tracker and provide strategic guidance to Commercial/Marketing and agency partners on submission …
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