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, Compliance (West Coast Region). Reporting to the Senior Director, Compliance, this role will help execute elements of the Company’s healthcare compliance program, with an emphasis on auditing and monitoring of business activities. In addition, the candidate for this position will work closely with 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 West Coast Region, requiring extensive air travel to support a robust compliance monitoring program. Candidates must reside within the state of California.
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 organization
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes
Monitoring Program Support
- Provide support to Director, Corporate Compliance in data gathering and execution of quarterly data monitoring activities related to employee adherence to Company Compliance Policies
- Update and assist with design and maintenance of monitoring dashboard for regional and global visibility to completion of annual monitoring activities
- Conduct monitoring activities, including, but not limited to field rides, speaker programs, virtual programs, and advisory boards
Requirements / Qualifications
- Bachelor's Degree required
- At minimum 5 years of experience working in the pharmaceutical/Biotech or healthcare legal, compliance, internal audit field
- 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
Experience, Knowledge and Skills
- 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
Salary and Benefits:
The anticipated salary range for this role is $125,000 - $140,000. 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 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.
Top Skills
What We Do
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options.
Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians
