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Manager/Senior Manager, Compliance - Chicago, United States - Axsome Therapeutics, Inc.
Description
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 Manager/Senior Manager, Compliance.
Reporting to the 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 remote position that requires extensivetravel to support a robust compliance monitoring program.
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 and a minimum of 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 resources
Salary & Benefits
The anticipated salary range for this role is $115,000 - $130,000. 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.