Senior Manager, Medical Content Review

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 Senior Manager, Medical Content Review to join the Scientific Affairs Team. Reporting to the Sr. Director, Medical Information, this highly-motivated individual will oversee the medical review of all medical content/materials in Medical Affairs. They will coordinate and facilitate the Medical Review Committee (MRC) process from beginning to end to ensure that all materials are appropriately reviewed by all necessary stakeholders prior to first use. This individual will liaise with content creators/project leads, cross-functional team members, and vendors. Therapeutic area experience in neuroscience (e.g., psychiatry or neurology) is highly desired.

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:

Medical Content Prioritization and Review Coordination 

• In collaboration with Medical Affairs content creator(s) and project lead(s), prioritize Medical Affairs projects (slide decks, ad board materials, HEOR and HOL one pagers/leave behinds) for MRC review and manages end-to-end MRC review process
• Responsible for scheduling, setting the agenda, and leading MRC meetings
• Upload materials/content for MRC review and monitors outstanding MRC reviewers (following up with reviewers as needed/necessary)
• Coordinate comment reconciliation following MRC reviews 
• Notify content leads when materials/content are going to expire; archives expired materials
• Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault MedComms)
• Quality check (QC) all final/approved documents 
• Update MRC SOP and generates other process documents as needed

Budget and Vendor Management 

• Assist function leads in tracking budget spend for vendors used for assigned medical content projects within Scientific Affairs (in collaboration with content creators and SMEs)
• Communicate with vendors and ensures reviewer feedback is incorporated into medical content projects 

Systems Management and Training 

• Attend ongoing Veeva MedComms meetings and participates in systems configuration efforts
• Tracks projects and establishes system alerts 
• Utilize system and process knowledge to maintain and contribute toward process improvement which positively impacts metrics associated with activities of the MLR Review process
• Provide MRC process and system training for new users 

 Scientific Affairs and Medical Information Project Management Support 

• Support Scientific Affairs and Medical Information leadership in developing and managing project plans for key initiatives
• Lead team efforts for content organization within SharePoint
• Assist function leads with contract routing and document retention/storage

Requirements / Qualifications

• Advanced scientific or clinical degree (MS+)
• Minimum of 5 years relevant experience required (agency or pharma)
• Experience in Scientific Writing / Scientific Reviewing / MRC
• Experience with use of Veeva Vault PromoMats / MedComms
• Project management experience (PMP certification preferred)

Experience and Knowledge

• CNS experience (psychiatry, neurology) preferred
• Excellent teamwork, stakeholder management skills 
• Proven ability to manage multiple tasks, set priorities, and meet deadlines 
• Ability to successfully manage competing priorities and cross-functional projects 
• Familiar with laws and regulations regarding US drug/device advertising and promotion, including industry best practices 
• Medical Information or Medical Communications experience

Salary and Benefits 

The anticipated salary range for this role is $135,000 - $160,000. 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 incl