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
Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
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)
