Manager/Senior Manager, Compliance (Southeast Inland Region)

Axsome Therapeutics•Louisville, KY

11h•$115,000 - $135,000•Onsite

About The Position

Axsome Therapeutics is seeking a Manager/Senior 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 Southeast inland Region, requiring extensive travel to support a robust compliance monitoring program. Candidates must reside within the Southeast Inland Region.

Requirements

Bachelor’s Degree is required
A minimum of 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.
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
Ability to travel extensively to support a robust compliance monitoring program; travel will include field rides, live monitoring of speaker programs, and advisory boards
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

Responsibilities

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
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
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