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Associate Director, Compliance

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Associate Director, Compliance is a member of the Legal and Compliance Department who has responsibility for supporting the Business Ethics and Compliance Program and related healthcare-compliance projects. Leveraging advanced experience, the incumbent assists in identifying and mitigating risks and developing and driving key compliance policies and initiatives.

Key Responsibilities

• Identify compliance-related gaps in current processes or practices and develop corresponding mitigation plans, especially with respect to healthcare compliance.

• Mitigate risk through reinforcing established procedures, spotting and escalating issues to Compliance leadership, and modeling business integrity and ethical behavior.

• Work closely with the Chief Compliance Officer and Compliance leadership to shape the Business Ethics and Compliance Program.

• Support the development and execution of FMI brand, scientific, and business plan

• Advise functions across FMI (e.g. Commercial and Medical Affairs) on corporate compliance concerns related to business processes.

• Provide support to FMI functional teams to ensure training is aligned with compliance priorities and dedicates sufficient focus to cover important compliance topics.

• Develop and maintain policies and procedures for the general operation of the Business Ethics and Compliance Program and its related activities and manage day-to-day operation of the Business Ethics and Compliance Program.

• Develop and deliver training to ensure that FMI employees are properly trained on compliance resources, risk areas, policies and procedures and reporting duties.

• Assist with and participate in monitoring and auditing activities to assess and detect risk areas and potential areas of concern within the Business Ethics and Compliance Program.

• Assist and participate in compliance investigations arising from alleged instances of non-compliance.

• Prepare and present updates to the Compliance Advisory Committee and FMI’s Senior Management Team and keep the Compliance Advisory Committee and the Senior Management Team generally informed of the operation and progress of the Business Ethics and Compliance Program.

•  Keep apprised of compliance trends in life sciences industry and incorporate improvements as applicable for FMI.

• Lead or support other critical initiatives as required.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelors Degree and 7+ years of progressively responsible experience in a compliance role including 2+ years of healthcare compliance experience in the life sciences industry

Preferred Qualifications

• Juris Doctor preferred

• Certification in compliance, such as CHC, CCEP, CIPP, CCP, CHPC

• 2+ years of experience:

  • within healthcare compliance in the life sciences industry, focused in the diagnostics sector or alternatively in the device or therapeutics sectors
  • working within a broad based, comprehensive compliance program, with demonstrated success in developing and implementing a program
  • working in a large law firm specializing in healthcare matters and healthcare compliance
  • with learning management systems
  • delivering and developing training related to compliance

• Strong understanding of policies and procedures related to healthcare compliance issues, including anti-kickback, privacy, e.g. HIPAA and GDPR, False Claims Act, and Stark Law

• Advanced Microsoft Word, Excel, and PowerPoint skills

• Strong professional and interpersonal skills and a demonstrated ability to work effectively and congenially with employees at diverse levels

• Clear, concise and persuasive writing and presentation skills

• Strong orientation to deadline and detail

• High level of integrity and ethics

• Commitment to reflect FMI's values: Patients, Passion, Innovation, and Collaboration

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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