Life Science Compliance Manager

Fujifilm

3d•$145,000 - $165,000•Remote

About The Position

The Regulatory Compliance Manager (Corporate) is a member of the FUJIFILM Holdings America Corporation Department 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. Commuting distance to Valhalla, NY for this position is preferred.

Requirements

Juris Doctor (J.D.) degree from an accredited law school.
Minimum of 5 years of in Med Devices/Pharma compliance experience.
Minimum of 7 years of Anti-Corruption compliance experience.
Minimum of 2 years of experience with Antitrust.
Strong understanding of healthcare regulations (e.g., Anti-Kickback Statute, False Claims Act) and global compliance frameworks (e.g., FCPA, UK Bribery Act).
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.

Nice To Haves

Licensed attorney preferred.
Certified Compliance & Ethics Professional (CCEP)
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.

Responsibilities

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, anti-corruption, 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 Healthcare 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.
Perform and manage third-party intermediary due diligence.
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 FUJIFILM, Holdings subsidiaries on topics related to FUJIFILM, Holdings 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.
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 FUJIFILM, Holdings, 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.