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 timelines to meet critical business deadlines and launch initiatives
- Responsible for tracking promotional materials from inception through approval and provide actionable actions where there are workflow issues, maintaining appropriate systems and documentation files, and coordinating any associated regulatory submissions within timelines
- Monitor document lifecycle, including reapprovals and expiry of materials in accordance with PRC SOP
- Provide 1:1 training to internal and external stakeholders on PRC Policy and Procedure, including refresher training, and create guidance documents as necessary
- Proactively lead project work supporting continuous improvement and process innovation, and partnering with the PRC team to share ideas and support team growth
- Receives project assignments from supervisor for PRC operations; manages priorities and timelines for projects with minimal supervision
Requirements/Qualifications
- BS or BA degree
- A minimum of 3-5 years of experience in the drug development industry with at least 2 years’ experience with Promotional Review Committee/Medical Legal Review
- Experience with Veeva Vault PromoMats or similar electronic management system
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Experience and Knowledge
- Experience managing complex projects, ensuring timelines, deliverables, and stakeholder communications are effectively handled
- Prior experience coordinating, establishing and managing high performing committees or similar groups, ensuring effective collaboration and decision-making processes
- Knowledge of best practices in promotional review processes, including the use of review tools and systems
- Experience working with cross-functional teams, including legal, medical, marketing, and regulatory departments, and with all levels of an organization
- Strong organizational skills to manage multiple projects, timelines, and committee activities simultaneously
- Excellent written and verbal communication skills to effectively convey feedback, decisions, and rationale to various stakeholders
- Strong decision-making skills to evaluate information, consider alternatives, and make informed recommendations
- Ability to resolve problems logically, quickly and proactively
- Experience in mediating and resolving conflicts within committee settings, ensuring smooth decision-making processes
- Exceptional attention to detail and experience with proofreading
- Strong computer aptitude, must be proficient in using software and tools for project management, document management, and review processes (e.g., Microsoft Office, Adobe Acrobat, promotional review systems)
Salary and Benefits:
The anticipated salary range for this role is $110,000 - $135,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
