Sr. Healthcare Compliance Specialist, TA

Job Summary

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

The Senior Healthcare Compliance Specialist supports the development, implementation, and continuous improvement of the Terumo Corporate Compliance Program at Terumo Americas Holding and certain of its subsidiaries (collectively, “TAH”), including compliance operations and corporate governance.

This position is responsible for assisting the Head of Compliance and/ or designee with the following tasks, among others: 

• Supporting the execution of monitoring and testing plans at a group level, focused on high-risk areas (e.g., anti-bribery and corruption, sanctions, data privacy, and internal controls), leveraging technology and data analytics across multiple sources to provide insights to management and commercial teams;
• Proposing, supporting, and executing remediation plans, including, but not limited to, training, job aids, and other associate resources;
• Supporting the Sunshine Act reporting process, including data collection, validation, and submission, ensuring timely and compliant reporting in line with TAH processes;
• Supporting the third-party risk management program, including the review of due diligence reports, approvals, and development of dashboards to identify and monitor high-risk areas;
• Supporting additional compliance program activities as needed, including compliance review of interactions with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs), contract administration, and the development of tools and guidance (e.g., checklists, procedures);
• Performing other compliance-related activities as required

Job Details/Responsibilities

The Terumo Americas Holding Senior Compliance Specialist is responsible for assisting the Compliance Team with the following key activities, including, but not limited to: 

Monitoring and Testing: Support the implementation and execution of monitoring and testing plans at group level, including:

• Conducting monitoring and testing across high-risk areas, as identified by TAH, including but not limited to, HCP engagements, events, travel and expenses, distributor payments;
• Developing dashboards and reports; delivering monthly, quarterly, and annual analytics to management and commercial teams;
• Supporting investigations in alignment with Compliance Team;
• Preparing follow-up communications and corrective actions;
• Maintaining and updating monitoring and corrective action logs;
• Delivering policy training and re-training to associates as needed.

Sunshine Reporting: Support the end-to-end Sunshine Act reporting process, including data collection, validation, submission, and remediation; 

Policies, Training and Communication: 

• Support the implementation and rollout of Compliance policies and SOPs in line with the TAH compliance framework; 
• Contribute to training, communication, and awareness initiatives to promote a culture of ethics and compliance; 
• Support internal and external training (as applicable) and support the measurement of training effectiveness.

Third Party Risk Management: 

• Support the third-party risk management program, including assisting in the review of due diligence reports and approval processes.

HCP/HCO Compliance Interactions review: Support compliance review of HCPs or HCOs Interactions and contract administration, including:

• Assisting in compliance reviews and approvals;
• Supporting HCP screening and documentation;
• Maintaining contract trackers and incident logs;
• Providing metrics and data analytics;
• Delivering relevant policy training and guidance.

Business Support: Serve as the first line of communication to the business for reviewing local requests and documentation.  

Governance & Committees: Support the organization and coordination of selected Compliance Committees.

Audits: Assist in the preparation of documentation for Internal Audits.

Assist with other reasonable compliance-related activities, as requested from time to time

Working Conditions/Physical Requirements

QUALITY REQUIREMENTS 

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

• Take care of your own health and safety and that of others who maybe affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• Ethical, with a strong understanding of compliance risks and a good sense for practical solutions.
• Problem solving — the individual successfully identifies problems of different degrees of complexity, gathers and analyzes information skillfully, and provides practical and value-added solutions and advice in a timely manner.
• Business-oriented—the individual is proactive and flexible, manages difficult client/customer situations, responds promptly to customer needs, solicits customer feedback to improve service, responds to requests for service and assistance and meets commitments with a “can-do” attitude. 
• Strong interpersonal skills—ability to interact effectively with associates at all levels in all departments of the organization. 
• Oral communication—the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts meetings. 
• Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and is able to read and interpret written information. 
• Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans. 
• Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality. 
• Adaptability—the individual adapts to changes in the work environment, manages competing demands and is able to deal with frequent changes, delays or unexpected events. 
• Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance. 

Qualifications/ Background Experiences

Minimum Knowledge & Experience required for the position: 

• Bachelor degree required, OR  A minimum of five years’ experience in Compliance, or Finance, or Audit field, OR  Any similar combination of education and experience. 
• An advanced degree (master, etc.) is considered a plus. A compliance or audit certification is also considered a plus. 
• Proficient in SAP, Concur, Microsoft software (excel, PowerPoint, word), Power BI and C-Event is a plus.
• Experience leveraging digital tools and AI to enhance data analytics and efficiency is desirable.
• Knowledge of relevant laws (FD&CA, Anti-kickback Statute, False Claims Act, Foreign Corrupt Practices Act, HIPAA, Sunshine Act, and applicable State laws), regulations, industry guidance and best practices regarding ethical and compliant conduct in sales, marketing, and medical activities is preferred.  
• Ability to work independently and within a team of people from diverse cultural and national backgrounds.