• Compliance Manager

    Job Locations US-WI-Madison
    Req No.
    2017-2067
    Category
    Human Resources, Legal & Organization Engineering
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Compliance Manager has various responsibilities for effectively and efficiently executing a compliance program designed to meets 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 policies as well as assisting with investigations as needed.  This position will also serve as a point of contact to provide guidance to internal clients and will assist in monitoring and auditing efforts conducted by the compliance program. The Compliance Manager must have strong attention to detail and the ability to identify and mitigate potential risks for the company.

    Essential Duties and Responsibilities

    • Actively contribute to and assist with the annual regulatory compliance review and other regular compliance assessments across the business and implement risk mitigation plans.
    • Help ensure that the healthcare regulatory compliance program (the “Compliance Program”) is designed and run in a manner comporting with laws, regulations and industry standards that include, among other topics, state and federal anti-kickback statutes, Stark compliance, open payments and related regulations and reporting practices (e.g., the Sunshine Act), compliance with FDA, CMS and 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 and communication, including the delivery of content to various audiences. Some travel will be required.
    • Serve as a subject matter expert to provide guidance to internal clients on various matters pertaining to laws, regulations and industry standards that include, among other topics, state and federal anti-kickback statutes, Stark compliance, open payments and related regulations and reporting practices (e.g., the Sunshine Act), compliance with FDA, CMS and 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 )
    • Effectively 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.
    • Effectively work with the Director of Compliance, Chief Compliance Counsel and other internal legal counsel 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 (e.g., Finance, Commercial, Human Resources) to direct compliance issues to appropriate existing channels for investigation and resolution.
    • Implement and deliver appropriate training under the Compliance Program
    • Assist with monitoring and auditing activities conducted by the compliance program
    • Effectively 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.

    Qualifications

    Education and Experience

    • Bachelor’s degree or equivalent experience & education combination. 
    • At least 4 years of experience in functions of Compliance, Legal, or Regulatory in a healthcare or life sciences company.  Direct experience with device and/or lab companies a plus.

     Mandatory Skills

    • Detailed knowledge of medical device and laboratory compliance regulations standards and best practices.
    • Excellent project management skills including coordination, communication and 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 independently identify and analyze issues and to exercise sound judgment with the resolution of those issues.
    • Ability to work on multiple projects and a variety of complicated tasks at the same time and prioritize tasks.
    • Strong interdepartmental collaboration skills; willingness to engage across teams and demonstrates the ability to lead indirectly through influence.
    • Leadership skills necessary to promote a compliance-oriented culture within the organization.

    Exact Sciences is 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. The Company’s affirmative action program is available to any applicant or employee for inspection upon request. 

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