Exact Sciences Corporation

Compliance Manager

Job Locations US-WI-Madison
Req No.
2021-8666
Category
Human Resources, Legal & Organization Engineering
Type
Regular Full-Time

Summary of Major Responsibilities

The Compliance Manager is responsible for effectively and efficiently executing all elements of a healthcare Compliance Program designed to meet legal and regulatory expectations. This position will work with Compliance leadership and functional teams throughout the organization to enhance and operationalize policies, procedures, and strategies of the Compliance Program and its related activities. The Compliance Manager will be responsible for the continual development of training and communications; including, but not limited to, drafting and/or updating policies and related training content, managing Compliance communication channels, and assisting with investigations, as needed. This role will serve as a point of contact to provide guidance to internal clients. The Compliance Manager must have strong attention to detail and ability to identify and mitigate potential risks for the company.

Essential Duties and Responsibilities

  • Train salesforce on high-risk healthcare provider (HCP) interactions and provide coaching and guidance on compliant interactions to internal clients.
  • Conduct training throughout the Company on various policies & procedures.
  • Contribute to and assist with annual regulatory compliance reviews, and other compliance assessments across the business, and implement risk mitigation plans.
  • Serve as subject matter expert to provide guidance to internal clients and ensure the healthcare regulatory Compliance Program, the “Compliance Program,” is designed to run in a manner to comply with laws, regulations, and industry standards; including, but not limited to, state and federal anti-kickback statutes, Stark compliance, open payments and related regulations and reporting practices (e.g., the Sunshine Act), compliance with Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), relevant regulatory requirements, and compliance with applicable corporate codes and policies (e.g., the Company’s Code of Conduct on Interactions with Health Care Professionals, which is based on the AdvaMed Code of Ethics on Interactions with Health Care Professionals).
  • Support the Compliance Program through the creation of effective training, communication, and the delivery of content to various audiences.
  • Liaise with functions across the organization to implement, develop, and maintain policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct.
  • Manage various day-to-day operational aspects of the Compliance Program, as assigned.
  • Work with all levels of the compliance and legal team on compliance policy decisions, procedures, issues, and investigations.
  • Identify potential weaknesses in the Compliance Program and proactively suggest improvements to address them.
  • Collaborate with other departments to direct compliance issues to appropriate existing channels for investigation and resolution.
  • Design, create, implement, and deliver effective training under the Compliance Program, using various delivery mechanisms; including, but not limited to, learning management system, podcasts, and live facilitator training, both virtual and in-person settings.
  • Assist with monitoring and auditing activities conducted by the Compliance Program.
  • Collaborate with cross-functional departments to ensure accurate tracking of transfers of value to health care professionals and teaching hospitals.
  • Consult and/or serve on corporate compliance committees.
  • Administer and oversee various programmatic elements of the Compliance Program; including, but not limited to, Corporate Grants Committee, Integrity Alertline, conflict of interest disclosures, and field relations program.
  • Excellent project management skills; including, but not limited to, coordination, communication, adherence to budget and completion goals, prioritization, and troubleshooting.
  • Strong written, verbal, and presentational communication skills; ability to present to various levels within the company as well as external professional audiences.
  • Ability to work on multiple projects and a variety of complicated tasks at the same time and prioritize tasks.
  • Strong interdepartmental collaboration skills with the willingness to engage across teams.
  • Ability to analyze processes and determine if adequate controls are in place and appropriate for the related activity.
  • Ability to field questions from individuals throughout the company and accurately and correctly provide guidance on questions and requests remitted.
  • Ability to take direction and independently work towards achievement of projects.
  • Ability to independently identify and analyze issues and to exercise sound judgment with the resolution of those issues.
  • Effective leadership skills to promote a compliance-oriented culture within the organization.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to work designated schedule.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability and means to travel between local Exact Sciences locations.
  • Ability to travel 35% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Bachelor’s degree in Business, Finance, Human Resources, Legal, Operations, or field related to the essential duties of the job.
  • 4+ years of experience working in compliance, legal, operations, regulatory, sales, sales training or sales leadership functions in a healthcare, life sciences, or laboratory company/industry.
  • Demonstrated ability to lead indirectly through influence.
  • Demonstrated knowledge of the Office of Inspector General (OIG) Compliance Program Guidance and the AdvaMed Code of Conduct on Interactions with U.S. Health Care Professionals (revised 1/1/2020).
  • Demonstrated knowledge on interactions between federal agencies mandated to provide oversight of marketing and healthcare expenditures; including, but not limited to, CMS, FDA, OIG, and Department of Justice (DOJ).
  • Detailed knowledge of medical device and laboratory compliance regulations standards and best practices.
  • Proficient in Microsoft Office.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
  • Authorization to work in the United States without sponsorship.

Preferred Qualifications

  • 1+ years of experience drafting policies and procedures to provide guidance on HCP interactions for a life sciences company.
  • 1+ years of experience designing, building, and delivering effective training; including, but not limited to, facilitation of training and designing training for assignment in learning management system.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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