Manager, Compliance (Southwest Region)

The role

This role executes elements of the healthcare compliance program including policy management, auditing, monitoring of business activities, and HCP payment transparency reporting. The person will support compliance investigations, training, and monitoring workstreams.

What you will do

• Support development, implementation, and maintenance of the compliance program
• Support implementation of FDA and OIG guidance and emerging regulations to policies and training
• Maintain understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance
• Support creation and maintenance of comprehensive compliance training plan
• Facilitate creation of Compliance training content
• Review and manage Compliance training assignments in training management system
• Track and assist with record retention of all Compliance training records
• Review and monitor Compliance training assignments and completion
• Provide support in data gathering and execution of quarterly data monitoring activities
• Participate in live monitoring of field activities such as patient events, advisory boards, symposia and hub activities

Required qualifications

• Bachelor’s Degree
• 4+ years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field
• Ability to travel extensively to support a robust compliance monitoring program
• 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
• Demonstrated effectiveness operating in complex organizational and regulatory environments
• Excellent written, oral, and presentation skills
• 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

Nice to have

• Experience in-house, at a regulatory agency, or at a major law firm

Benefits

• annual bonus
• significant equity
• generous benefits package

Before you apply

• Candidates must reside within the Southwest Region

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their 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.