Associate Director, Ethics and Compliance

Work set-up: 
Full Remote
Contract: 
Experience: 
Entry-level / graduate
Work from: 

Offer summary

Qualifications:

Bachelor’s degree in a relevant field., Minimum of 8 years of experience in the life sciences industry and healthcare ethics and compliance., Knowledge of pharmaceutical regulations such as the Anti-Kickback Statute, False Claims Act, and FDA rules., Certification in Healthcare Compliance (CHC) or Ethics (preferred)..

Key responsibilities:

  • Support the development and maintenance of the company's Compliance Program.
  • Assist in conducting healthcare risk assessments and implementing mitigation plans.
  • Manage compliance monitoring activities, including audits and investigations.
  • Provide education and training on laws, regulations, and industry standards.

Esperion Therapeutics logo
Esperion Therapeutics Pharmaceuticals SME https://www.esperion.com/
201 - 500 Employees
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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: Associate Director, Ethics and Compliance

 

The Associate 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 the Office of Inspector General (OIG) Guidance, the U.S. Sentencing Guidelines, and the Department of Justice guidance.

 

Preferred Location: Remote – US 

 

Essential Duties and Responsibilities*

  • Help drive a culture of integrity across the organization and assist in the ongoing evolution of Esperion’s Healthcare Compliance Program.
  • Support annual Healthcare Risk Assessment and development and implementation of Risk Mitigation Plans and activities (i.e., Conducting Healthcare Compliance Audits in higher risk areas identified through Risk Assessments 
  • Manage risk-based Compliance Monitoring Program including oversight of Compliance Auditing and Monitoring activities (i.e., planning and execution of field-based monitoring activities at live and virtual events/programs). 
  • Assist Chief Compliance Officer with Investigations, documentation, and remediations stemming from identified potential compliance issues (i.e., hotline reports)
  • Maintain current understanding of laws, regulations, and industry codes applicable to pharmaceutical/biotechnology business activities and compliance, along with recent trends and changes, and help provide related internal education and training.
  • Update Healthcare Compliance Policies and Procedures in response to shifts in laws regulations and industry codes or in response to newly identified risks inherent to evolving business plans.

*additional duties and responsibilities as assigned

 

 

Qualifications (Education & Experience)

  • Bachelor’s degree, minimum of 8 years of experience in the life sciences industry and specific healthcare ethics and compliance experience required
  • Certification of Healthcare Compliance (CHC) or Certified Compliance and Ethics Professional (CCEP) a plus
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically the PhRMA Code on Interactions with Healthcare Professionals.
  • Proven ability to emulate Esperion’s Core Values of Collaboration, Patients, Passion, People, Integrity and Accountability
  • Ability to manage multiple projects to completion on time, meeting internal and external deliverables with a high degree of accuracy.
  • Highly proficient with Microsoft Office Suite (Excel, PowerPoint, Word, Outlook, Teams)
  • Competencies: Attention to Detail, Highly Organized, Strong Interpersonal Skills, Team Player, Self-Starter, Discrete, Excellent Verbal and Written Communication skills, Customer Service Orientation, Time Management and Project Management skills.
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. 
  • Travel Requirements up to 10%.

Required profile

Experience

Level of experience: Entry-level / graduate
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Microsoft Office
  • Non-Verbal Communication
  • Time Management
  • Teamwork
  • Customer Service
  • Organizational Skills
  • Detail Oriented
  • Social Skills

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