Healthcare Compliance Manager

Job Summary

Healthcare Compliance Manager manages, and coordinates activities related to the development and implementation of Terumo’s Company Corporate Compliance Program across assigned Terumo business division. Responsible for developing and managing effective training and providing continuous compliance guidance to assigned business functions.

Healthcare Compliance Manager will be responsible for implementing and managing a third-party management program. In addition, will manage corporate compliance communication strategy, draft policies and procedures as needed, and interface with legal, business and operations teams to ensure all relevant laws and rules are understood and complied with.    

Job Details/Responsibilities

• Manage corporate compliance communication plan, enhance compliance digital communication strategy, develop standardized compliance news alert across Terumo entities, drive focus group activities to enhance and maintain a culture of compliance.; 
• Develop a risk-based compliance training curriculum, develop related content, define training modules by subject matter, delivery method and targeted audience and plan accordingly; performs training analysis and monitor training effectiveness; perform in person training.
• Implement a third-party management program for TMC and its managed businesses, perform due diligence on third parties as needed, proactively defines remediations plans; monitor high risk third parties Provide data analytics to senior management on high risk third parties. Support other Terumo entities in launching the third-party management program, configure the designated due diligence platform and establish monitoring dashboard.
• Enhance and manage the HCP Interaction and Engagement Framework (qualification forms, contract engagement process, HCP agreements and payments).
• Partner with all levels of key divisional business functions to provide policy interpretation and requirements, compliance risk assessment, trend analysis and best practice recommendations.
• Draft and disseminate written policies, procedures, working instructions and compliance related guidance. Coordinate with compliance departments across various Terumo entities to ensure consistent adoption of Terumo compliance minimum requirements.
• May manage, oversee, monitor the eLMS system to ensure compliance training is rolled out timely to identified audiences, and training participation and success rates are tracked and monitored.  Revise the training curriculum as needed.
• Act as project manager for the compliance department.
• Work cross-functionally with legal and finance to implement commercial projects, initiatives, that have health care compliance-related implications.
• Perform other duties as assigned. 

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Ethical, with a strong understanding of compliance risks and a good sense for practical solutions.
• Excellent oral and written communication skills.
• Expert attention to detail. 
• Ability to interact effectively with associates at all levels in all departments.
• Proactive, flexible, responsive and resourceful.
• Ability to communicate clearly, concisely and effectively and to listen carefully on complex topics across potential clients.
• Ability to grasp best practices and use them to provide client solutions.
• Ability to review and synthesize data into meaningful reports. 
• Ability to quickly establish trust and rapport with other personnel.
• Ability to manage and prioritize multiple projects in a service-oriented environment.
• Ability to identify the root cause of an issue to develop effective solution. 
• Ability to influence business decisions and business partners.
• Knowledge of laws (FD&CA, Anti-kickback Statute, False Claims Act, Foreign Corrupt Practices Act, HIPAA, Sunshine Act, and State laws), regulations, industry guidance including Advamed and/or PhRMA Code on Interactions with Healthcare Professionals, and best practices regarding compliant sales, marketing, and medical activities is preferred. 
   

Qualifications/ Background Experiences

• Bachelor’s degree and a minimum of 7 years related experience in the medical device,  healthcare or pharmaceutical industry required or equivalent combination of education and prior work experience. Juris Doctorate and Compliance Certification a strong plus.
• Experience drafting policies, managing training programs preferred in compliance or business function, and/or in the medical devices industry or pharmaceutical.
• Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners.
• Experience with Concur preferred.