Manager, Compliance (Southwest Region)

About this role

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X .

About This Role

Axsome Therapeutics is seeking a Manager, Compliance. Reporting to the Director, Monitoring and Investigations, this role will help execute elements of the Company’s healthcare compliance program, with an emphasis on policy management, auditing and monitoring of business activities and HCP payment transparency reporting. In addition, the candidate for this position will work closely with the Chief Compliance Officer, the Director, Compliance, and other business colleagues and shall assist with managing Axsome’s compliance operations in accordance with company policies, applicable state and federal regulations, and industry standards including those of the FDA, OIG, and CMS.

This is a field-based position that covers the Southwest Region, requiring extensive travel to support a robust compliance monitoring program. Candidates must reside within the Southwest Region.

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

General Compliance Program Support

• Support the development, implementation, and maintenance of the compliance program, including compliance investigations and training and monitoring workstreams designed to facilitate adherence to compliance policies and healthcare compliance regulations

• Support the implementation of new and existing FDA and OIG guidance documents, emerging state and federal regulations, and industry codes to current policies, training and monitoring activities as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations

• Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes

• Additional responsibilities as assigned

Training Program Support

• Support Director, Monitoring and Investigations, in creation and maintenance of comprehensive compliance training plan in connection with compliance policies, including but not limited to: new hire orientation, role or franchise-based training curricula, anti-bribery and anti-corruption (ABAC) program, privacy, and promotional regulations

• Facilitate creation of Compliance training content, including alignment across trainings on core Compliance concepts, determination of best formats and methods for training delivery

• Review and manage Compliance training assignments in training management system for enterprise-wide, franchise-specific and executive training curriculums

• Track and assist with record retention of all Compliance training records in training management system

• Review and monitor Compliance training assignments and completion, including following-up with employees who are late on assigned training

• Development of additional slide decks to support the training program

Monitoring Program Support

• Provide support to Director, Corporate Compliance in data gathering and execution of quarterly data monitoring activities related to employee adherence to Corporate Business Policies

• Participate in live monitoring of field activities such as patient events, advisory boards, symposia and hub activities

• Update and oversee design and maintenance of monitoring dashboard for regional and global visibility to completion of annual monitoring activities

• Manage communication to Sales Directors regarding annual Director-led monitoring requirements, track completion and documentation of Director-led monitoring of field teams

• Conduct monitoring activities not limited to sitting in on field ride, speaker programs, virtual programs, and advisory boards

Requirements / Qualifications

• Bachelor’s Degree is required

• 4+ years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.

• Ability to travel extensively to support a robust compliance monitoring program; travel will include field rides, live monitoring of speaker programs, and advisory boards

Experience, Knowledge and Skills

• Experience with statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally

• Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines

• Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act

• Demonstrated effectiveness operating in complex organizational and regulatory environments

• Excellent written, oral, and presentation skills

• A strong sense of professionalism, and the drive to provide superb and timely support to internal clients

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