New Job Compliance Associate In Massachusetts

About the Job

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.