Senior Compliance Specialist

Overview:

FUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment. Fujifilm’s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. The Synapse® Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record. REiLI®, Fujifilm’s artificial intelligence initiative, combines Fujifilm’s rich image -processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more information, please visit healthcaresolutions-us.fujifilm.com.

Job Title: Senior Compliance Specialist

Job purpose

The accomplished Senior Compliance Specialist will support FUJIFILM’s Corporate compliance program operations to ensure high ethical standards are observed and compliance program is effective and efficient. The successful candidate will operate independently and with limited management oversight. The position will report to the Director of Corporate Compliance.

Duties and responsibilities 

• Develop and implement elements that support FUJIFILMs compliance program in line with OIG’s guidance of an effective compliance program, specifically
  
  • Code of Conduct, Policies and Procedures development, implementation, and compliance.
  • Training and Education content development, execution and training completion tracking.
  • Communication development and execution.
• Auditing and Monitoring plan maintenance, execution, results analysis, reporting, remediate actions implementation and tracking.
• Mange Transparency Program data collection, validation and reporting process.
• Manage Third Party program including due diligence process, annual certifications and training, and other applicable programs.
• Assess and review business Compliance requests, escalate, when needed.
• Prepare management reports on the status of the Compliance program and other topics.
• Maintain industry knowledge and regulations.
• Develop data analysis tools and analytics.
• Work with cross-functional teams on initiatives.
• Address corporate requests and support continuous improvement of the Compliance program.
• Promote culture of compliance.

Qualifications

• Bachelor’s or Advanced Degree or equivalent experience.

• 5-7 years of experience in a similar role or function in the global medical technology, Pharmaceutical or biotechnology company.

• Demonstrated experience taking ownership of issues and providing timely and actionable guidance.

• Strong analytical and Problem-solving skills.

• Self-starter, able to meet goals and exercise sound judgement in various ambiguous situations, escalate issues, as appropriate.

• Ability to work with large amounts of data.

• Excellent project management skills and ability to identify areas of improvements and improve processes, provide effective solutions, and successfully implement them.

• Excellent verbal and written communication and research skills.

• Highly detail oriented.

• Advance analytical abilities and proficiency with MS Office (especially PowerPoint, Excel and Word).

• Ability to tactfully interact with associates.

• Solid understanding of laws, regulations and codes related to healthcare Anti-bribery/Anti-corruption laws, Foreign Corrupt Practices Act (FCPA), False Claims Statute, Anti Money Laundering and other applicable US laws and regulations.

• Healthcare compliance Certification (a plus).

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

• The ability to sit up to 75-100% of applicable work time.
• The ability to use your hands and fingers to feel and manipulate items, including keyboards up to 100% of applicable work time.
• Ability to stand, sit, talk, and hear for 75% of applicable work time.

Travel

• Occasional (up to 20%) travel may be required based on business need.

Equal Opportunity Employer

FUJIFILM is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.