Position OverviewThe Compliance Manager is a member of the FUJIFILM Holdings America Corporation reporting to the Corporate Compliance Director. The Compliance Manager will be responsible for managing the day-to-day operations of the company's compliance programs related to laws and regulations, including healthcare compliance, anti-corruption, antitrust, and anti-money laundering (AML). Under the supervision of the Corporate Compliance Director, this individual will ensure the effectiveness of compliance frameworks, oversee due diligence and monitoring activities, and support the ongoing development of policies, procedures, and training programs to foster a culture of integrity and compliance across the organization.
Job DescriptionResponsibilities- Develop and implement elements that support FUJIFILM's Medical Device Compliance Program in line with OIG's guidance and healthcare regulations.
- Draft, update, and maintain compliance-related policies, procedures, and guidelines. Conduct healthcare, anti-corruption, antitrust and anti-money laundering compliance policy, and procedure assessment. Support development of new or updated polices to address new risk areas or to improve operations and/or internal controls.
- Conduct healthcare, anti-corruption, antitrust, and anti-money laundering compliance risk analysis. Identify potential areas of compliance vulnerability and risk. Develop and implement action plans to mitigate potential risks.
- Develop and manage compliance training on the Fujifilm Medical Device Code of Conduct, Interactions with Healthcare Professionals Policy, Anti-Kickback, False Claims Act, HIPAA, Anti-Corruption Policy and Antitrust Policy among others, to educate employees on legal and ethical standards and to ensure a comprehensive understanding.
- Perform transaction monitoring review.
- Manage the third-party management program, including performing third-party intermediary due diligence, monitoring and advice to the business and subsidiaries on related matters.
- Perform the annual Anti-Corruption and Antitrust Self-Audits.
- Promote compliance awareness through ongoing communication and engagement initiatives.
- Collaborate with other members of the Compliance Department on Investigations and Policy Audit.
- Advise business subsidiaries on topics related to FUJIFILM Holding's Policies on Healthcare, Anti-Corruption, Antitrust and Anti-Money Laundering.
- Keep abreast of new legislation and enforcement matters affecting global companies as well as healthcare industry and compliance best practices.
- Support the transparency data collection, validation, and reporting process to ensure compliance with the applicable transparency reporting requirements (e.g., the Physician Payments Sunshine Act).
- Assist with review of grants, sponsorships and FMV evaluation requests, to ensure compliance with healthcare regulations.
- Assist with review of quotes, submissions, and other documentation in connection with government bids or government contracts or interactions.
- Collaborate closely with colleagues in Legal, IT, HR, Finance, Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting and remediation.
- Prepare management reports to FUJIILM Holding's, subsidiary management and FTYO CP&RM on incidents, investigations, emerging compliance challenges and general compliance activities.
- Conduct pre-acquisition due diligence of new healthcare businesses and develop integration plan.
- Support HIPAA Privacy Officer in executing responsibilities related to healthcare and HIPAA.
- Other duties as assigned.
Required Skills/Education- Minimum of 5 years of healthcare compliance experience in the medical device/pharmaceutical industry and minimum of 7 years of Anti-Corruption compliance experience with a Masters degree.
- Minimum of 3 years of healthcare compliance experience in the medical device/pharmaceutical industry and minimum of 5 years of Anti-Corruption compliance experience with a Juris Doctor (J.D.) degree from an accredited law school with admittance in good standing to at least one state bar
- Strong understanding of healthcare and anti-corruption regulations (e.g., Anti-Kickback Statute, False Claims Act, OIG's guidance of an effective compliance program, as well as DOJ's guidance on compliance program effectiveness standards, etc.), applicable industry codes (e.g., AdvaMed Code on Interactions with Healthcare Professionals) and global compliance frameworks (e.g., FCPA, UK Bribery Act).
- Certified Compliance & Ethics Professional (CCEP) preferred
- Experience in the development, initiation, maintenance, and revision of policies and procedures for the general operation of a healthcare compliance program and its related activities to prevent illegal, unethical, or improper conduct.
- Experience evaluating and auditing healthcare compliance matters to identify operational issues and recommend and implement strategies to resolve compliance problems.
- Exposure to compliance in multiple areas of substantive law, including, Anti-Corruption, Anti-Money Laundering, and Healthcare Compliance.
- Knowledge of SAP, Excel, and PowerPoint.
Desired Skills- Strong project management skills, to include managing and prioritizing multiple concurrent projects, and reporting progress and risks to colleagues and senior management.
- Demonstrated ability to advise and collaborate with management on compliance issues, facilitating risk assessment and developing practical business solutions.
- Excellent interpersonal, writing and communication skills.
Salary and Benefits- $145,000 - $165,000 depending on experience
- Medical, Dental, Vision
- Life Insurance
- 401k
- Paid Time Off
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