Position: Mid-Senior level

Job type: Full-time

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Job content

Summary Of Major Responsibilities

The Senior Compliance Manager, International will be responsible for providing compliance support and oversight to the International Business Unit. The position will report to the Senior Director of Compliance and will work in close collaboration with the Vice President, General Counsel - International. The successful candidate will have significant experience with compliance issues particular to the life sciences industry. Near-native English and at least one other business-relevant language are required.

The position is based in Zug, Switzerland.

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, FCPA and other anti-corruption laws, industry codes on interactions with healthcare professionals, and applicable corporate codes and policies.
  • Develop and implement processes and procedures to ensure compliance with:
    • laws and codes concerning industry interactions with healthcare professionals, including rules relating to prior approval of contracts with healthcare professionals and reporting of benefits conferred on healthcare professionals;
    • the FCPA and other anti-corruption laws, including due diligence procedures; and,
    • applicable export sanctions.
  • Advising the business on Compliance matters.
  • Support the compliance program through the creation of effective training and communication, including the delivery of content to various audiences.
  • 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 all levels of the Compliance and Legal team 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.
  • Design, create, implement, and deliver effective training under the Compliance Program using various delivery mechanisms including Learning Management System, podcasts, and live facilitator training in both virtual and in-person settings.
  • 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 healthcare professionals and teaching hospitals.
  • Consult and/or serve on corporate compliance committees.
  • Responsible for administration and oversight for various programmatic elements of the compliance program, including, but not limited to, Grants Committee, Integrity Alertline, Conflict of Interest disclosures, Field Relations Program, etc.
  • Ensure training of International staff on Compliance matters.
  • Conduct investigations into company activities where warranted.
  • Collaborate with global teams on the development and implementation of applications to automate and improve Compliance processes and procedures.
  • Good communications skills (written and oral), ability and experience in interacting credibly with the senior leadership.
  • Ability to juggle competing priorities in a reporting matrix and drive to results with high emphasis on quality.
  • Capacity to thrive in a cross-functional, multicultural, and collaborative team environment.
  • General eagerness to learn and ability to navigate new areas of the compliance landscape.
  • 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.
  • 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 nights and/or weekends.
  • 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.
  • Considerable periods of time may be spent concentrating and or analyzing data.
  • Ability and means to travel between Exact Sciences locations.
  • Ability to travel 25% of working time away from work location, may include overnight/weekend travel.
Qualifications

Minimum Qualifications
  • Master-2 level university degree or equivalent.
  • 7+ years professional experience in a compliance-related position in a life sciences company or firm advising in the life-sciences industry.
  • Near-native (C2) level fluency in written and spoken English and at least one other language relevant to Exact Sciences’ business (French, Italian, German).
  • Demonstrated ability to navigate complex legal and regulatory environments.
  • Demonstrated effective leadership skills to promote a compliance-oriented culture within the organization.
  • 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.
Preferred Qualifications
  • At least C1 proficiency in a third language, or more.
  • Experience with transparency reporting.
  • Strong IT and systems skills.
EEO Disclosure

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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Deadline: 05-05-2024

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