Manager, Compliance (Southwest Region)

The posting, as Axsome Therapeutics wrote it

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,

[…]
inical 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
• Strong problem solving, risk analysis, and project management skills
• Demonstrated ability to partner effectively with others in addressing complex issues
• Strong persuasive skills and sound business judgement
• Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources

Salary & Benefits

The anticipated salary range for this role is $115,000-$135,000. 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.