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Director, Ethics and Compliance

Key Facts

Remote From: 
Full time
Expert & Leadership (>10 years)
English

Other Skills

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    Needs Assessment
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    Accountability
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    Collaboration
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    Leadership
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    Multitasking
  • •
    Microsoft Excel
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    Microsoft PowerPoint
  • •
    Time Management
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    Personal Integrity
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    Virtual Teams
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    Organizational Skills
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    Persuasive Communication
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    Verbal Communication Skills
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    Microsoft Word
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    Microsoft Outlook

Roles & Responsibilities

  • BS/BA required; advanced degree in law or business preferred
  • 10+ years’ experience in the biopharmaceutical space with 7+ years specifically in Healthcare Compliance
  • Certification of Healthcare Compliance (CHC) or Certified Compliance and Ethics Professional (CCEP) a plus
  • Deep knowledge of laws and regulations applicable to U.S. pharmaceutical companies (e.g., FCPA, Fraud and Abuse, False Claims Act) and industry codes such as PhRMA

Requirements:

  • Develop and implement compliance policies, procedures, and guidance to ensure adherence to applicable laws, regulations, and industry standards; create training and communications in support of the Code of Business Conduct and HCP Interactions policies
  • Oversee reviews and approvals of needs assessment submissions for healthcare professional engagements and customer or advocacy organization funding arrangements; serve as a trusted advisor to business stakeholders
  • Support collection, remediation, and analyses of aggregate spend data and ensure timely reporting under the U.S. CMS Physician Payment Sunshine Act and state transparency laws
  • Represent the compliance function in the Third-Party Risk Management program during committee meetings, vendor risk reviews, and remediations

Job description

Company Overview


Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. 


Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.


Position Title: Director, Ethics and Compliance

 

The Director, Ethics and Compliance reports directly to the Chief Compliance Officer and supports the function in developing, implementing, and maintaining an effective Compliance Program that (1) supports and promotes a Companywide culture of ethics and compliance, and (2) meets or exceeds applicable regulatory standards for effective compliance programs, including those espoused in the U.S. Office of Inspector General (OIG) General Compliance Program Guidance.


Preferred Location: Remote – US 


Essential Duties and Responsibilities

  • Champion Esperion’s Core Values, drive a culture of integrity throughout organization, and support on-going efforts to continually improve Esperion’s Healthcare Compliance Program.
  • Develop and introduce compliance policies, procedures and guidance to ensure adherence with applicable laws, regulations and industry standards. 
  • Create and implement appropriate training, communications and direction in support of Esperion’s Code of Business Conduct, HCP Interactions Policies and other compliance-related doctrines.
  • Oversee compliance review and approvals of needs assessment submissions associated with healthcare professional engagements and customer or advocacy organization funding arrangements. 
  • Serve as a trusted business partner and advisor to business stakeholders.
  • Support collection, remediation and analyses of aggregate spend data and ensure timely reporting according to the U.S. CMS Physician Payment Sunshine Act and state transparency laws. 
  • Participate in Third-Party Risk Management program for Esperion by representing the compliance function during committee meetings, vendor risk reviews and remediations.
  • Additional duties and responsibilities as assigned


 

Qualifications (Education & Experience)

  • BS/BA required, advanced degree in law or business preferred
  • Certification of Healthcare Compliance (CHC) or Certified Compliance and Ethics Professional (CCEP) a plus
  • 10+ years’ experience within bio-pharmaceutical space with 7+ years specifically in Healthcare Compliance 
  • Deep knowledge of laws and regulations applicable to U.S. pharmaceutical companies, including FCPA, U.S. Fraud and Abuse and False Claims Laws, and industry codes such as PhRMA
  • Must emulate Esperion’s Core Values of Collaboration, Patients, Passion, People, Integrity and Accountability
  • Skilled at balancing compliance guidance with practical business judgment in fast-paced, evolving environments
  • Experience supporting compliant HCP and patient engagement, scientific exchange, market access and patient support programs.
  • Direct experience leading third-parties responsible for designing, implementing, overseeing, and improving Compliance programs 
  • Adept at managing multiple tasks simultaneously, working independently, and managing discrete areas of responsibility with limited supervision
  • Excellent organizational and time management skills and refined communication skills (verbal and written), including the ability to communicate persuasively
  • Highly proficient with Microsoft Office Suite (Excel, PowerPoint, Word, Outlook, Teams)
  • Occasional travel required to Esperion offices, field personnel locations and company meeting locations

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