Healthcare Compliance Manager

Job Summary

Healthcare Compliance Manager supports the Director – Healthcare Compliance on departmental initiatives in support of the development and implementation of the Company Ethics and Compliance Program across the assigned Terumo division(s).   

The Healthcare Compliance Manager is responsible for: 1) designing learning effective training solutions and curriculum for the organization, delivering training and tracking its effectiveness; 2) compliance policy and procedure update and management; 3) HCP interaction and engagement advisory and review; 4) responsible for managing third party management program, data analytics and remediation 5) support on periodic risk management assessments, as well as cross functional, intra-Terumo entity global or regional project management. 

Healthcare Compliance Manager is responsible for handling matters with an overall view to mitigate the Company’s Legal and Compliance risks, providing proactive and solutions-oriented compliance advice aligned with the Company’s Compliance Program that advances the business’ objectives and represent the Company’s interests.
 

Job Details/Responsibilities

• Responsible for developing strong relationships throughout the assigned Terumo division(s) and stakeholders to foster a consistent and collaborative approach to proactive compliance.
• Responsible to provide support and guidance to Terumo associates, acting as the Compliance Subject Matter Expert regarding compliance requirements with key initiatives including but not limited to the AdvaMed Code of Ethics, Interactions with Heath Care Professionals, Anti-Bribery & Anti-Corruption, Sunshine laws, and Terumo’s Code of Conduct.
• Responsible to create and develop engaging communications for a wide audience that contribute to an enhanced culture of compliance at the Company.  Work across departments and Terumo entities to develop communications including but not limited to regular messaging, compliance program updates, newsletters, ethics surveys, Integrity Day, Live events, and the Company Intranet.
• Responsible for the creation and development a risk-based compliance training curriculum, tailored to the audience and subject.  Monitors the effectiveness of the training program, delivers engaging live trainings, and incorporates results of the auditing and monitoring program into the training modules.
• Responsible to keep the written policies, procedures, working instructions and compliance-related guidance up to date in company systems and Intranet. Coordinate with compliance departments across various Terumo entities to ensure consistent adoption of Terumo’s minimum compliance requirements.
• Responsible for providing strategic advisory services to stakeholders on HCP/HCO/GO engagement and interactions, management, and new initiatives. Reviews and approves engagements and events as needed. Manages the compliance ambassador program.
• Responsible for management of the third-party management screening process and platform including continuous process improvements and management of high-risk third-parties.  Regularly monitors the health of the third-party due diligence screening efforts, remediation plans, and communicates risk to management accordingly.  Serves as Center of Excellence for other Terumo entities to ensure consistent adoption of Terumo’s minimum compliance requirements in third-party due diligence program.
• Partners with all levels of key divisional business functions to perform periodic healthcare compliance risk assessments, compile results, and track remediation plans, as appropriate.
• Lead strategic projects/initiatives for the compliance department.
• Actively contribute to propose, prepare, and implement innovative ways to create efficiencies within the compliance program, processes, and/or systems.
• Regularly report to management on the health of the Compliance program aligned with compliance objectives.
• Perform other duties as assigned. 
   

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Ethically driven with a strong understanding of compliance risks and a good sense for practical solutions.
• Growth mindset, with ability to find solutions to complex issues, via collaboration and partnership.
• 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.
• Passionate about technology and new AI powered compliance solutions. 
• 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.