Sr. Healthcare Compliance Specialist, TA
$86.9k - $121.88kTerumo Cardiovascular Group
Sr. Healthcare Compliance Specialist, TA Location: Somerset, NJ, US, 08873 At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy. The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida. Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide. At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat – progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what’s next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real‑world, impactful solutions for patients. Join us and help shape wherever we go next! 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. Responsibilities 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. 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 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. Environmental Health & Safety Requirements Take care of your own health and safety and that of others who may be affected by your actions. Work cooperatively 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 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. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k) with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long‑term disability, short‑term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range: $86,900 – $121,880. #J-18808-Ljbffr Terumo Cardiovascular Group
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