Life Science Compliance Manager jobs in United States
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FUJIFILM Holdings America Corporation · 1 day ago

Life Science Compliance Manager

FUJIFILM Holdings America Corporation is a leader in innovation across various industries, including healthcare. The Regulatory Compliance Manager will oversee compliance programs related to laws and regulations, ensuring the effectiveness of compliance frameworks and fostering a culture of integrity within the organization.

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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 HLUS subsidiaries on topics related to HLUS 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 HLUS, 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

Qualification

Juris Doctor (J.D.)Med Devices/Pharma complianceAnti-Corruption complianceAntitrust experienceHealthcare regulationsCertified Compliance & Ethics ProfessionalSAPExcelPowerPointProject managementInterpersonal skillsWriting skillsCommunication skills

Required

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)
Certified Compliance & Ethics Professional (CCEP)
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

Preferred

Licensed attorney preferred
Commuting distance to Valhalla, NY for this position is preferred

Benefits

Medical, Dental, Vision
Life Insurance
401k
Paid Time Off

Company

FUJIFILM Holdings America Corporation

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For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.

Funding

Current Stage
Late Stage
Total Funding
unknown
2006-06-13Acquired

Leadership Team

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Deepak Mahulikar
Chief Technology Officer
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Patrícia Colombo
Chief Compliance Officer
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Company data provided by crunchbase