As a member of the Legal and Compliance Department at Foundation Medicine, Inc. (FMI), the Compliance Associate is responsible for (i) assisting in the implementation and management of FMI's Business Ethics and Compliance Program and (ii) related healthcare-compliance projects and initiatives.
Key Responsibilities
Assist in managing day-to-day operation of the Business Ethics and Compliance Program, including:
Managing the Compliance-specific inbox daily for any inquiries and promptly resolving inquiries
Ensuring timely regulatory reporting, documentation, and filing
Assisting with audit remediation by working with the business and key stakeholders to implement recommended areas of improvement.
Embedding within various departments within the company to offer compliance guidance and training
Managing Compliance Program policies and documentation and keeping such documentation up to date
Educate and train employees on regulations and industry practices
Lead various projects related to healthcare compliance, including helping the team respond to any changes in the regulatory environment.
Assist Compliance leadership with preparing updates to the Compliance Committee and FMI's Senior Management Team.
Assist the business in system implementation, sharing of best practices, and in the development of tools to support responsible business practices.
Assist with and participate in monitoring and auditing activities to assess and detect risk areas and potential areas of compliance concern.
Keep apprised of compliance trends in life sciences and incorporate improvements; and
Assume additional responsibilities and special projects as directed, such as:
Assisting and participating in compliance investigations arising from alleged instances of non-compliance. Offer recommendations for improvement based on findings.
Assisting with the sanction-check process to screen independent contractors and vendors for excluded or debarred individuals or entities (e.g., Office of Inspector General List of Excluded Individuals/Entities, Government Service Administration List of Contractors Excluded from Federal Procurement and Non-Procurement Programs, etc.).
Assisting with breach response and notification in accordance with relevant privacy and electronic standards promulgated under the Health Insurance Portability and Accountability Act (HIPAA) and state electronic data security laws.
Other duties as assigned.
Qualifications
Basic Qualifications
Bachelor's Degree
2+ years of experience in a compliance role, legal compliance, or related role
Preferred Qualifications
JD, MBA, MPH, MPA or equivalent advanced degree
2+ years of experience in a life sciences company
Familiarity with healthcare laws/regulations including fraud and abuse laws (e.g., False Claims Act, Anti-Kickback Statute, Stark Act) and applicable privacy laws (e.g. HIPAA, GDPR, CCPA).
Demonstrated understanding of policies and procedures related to healthcare compliance issues, including any recent developments in the field
Demonstrated project management experience and ability to organize and prioritize.
Adept at understanding complex concepts and situations presented by the business environment.
Comfortable working in situations with no clear answer and with limited guidance.
Demonstrated ability to influence -particularly in situations with no authority.
Ability to adapt in a dynamic and high-growth environment.
Exceptional written, verbal, analytical, organizational, and problem-solving skills.
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)