Axsome Therapeutics, Inc. · 1 month ago
Manager/Senior Manager, Compliance (Southwest Region)
Dallas, TX
Full-time
Onsite
Mid, Senior Level
$115K/yr - $130K/yr
4+ years expAxsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. They are seeking a Manager/Senior Manager, Compliance to help execute elements of the Company’s healthcare compliance program, focusing on policy management, auditing, monitoring of business activities, and HCP payment transparency reporting.
BiopharmaBiotechnologyTherapeutics
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
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
Qualification
Required
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
Benefits
Annual bonus
Significant equity
Generous benefits package
Company
Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1B2025-05-13Post Ipo Debt· $570M
2023-06-28Post Ipo Equity· $225M
2019-12-23Post Ipo Equity· $200M
Leadership Team
H
Herriot Tabuteau
Chief Executive Officer
Recent News
2026-01-22
Clinical Trials Arena
2026-01-17
Company data provided by crunchbase