- Management of key HCP related compliance processes, controls and monitoring and testing activities such as:
- Support Sunshine Act reporting process, including collection and reporting of applicable data ensuring timely and compliant submissions and remediations
- Support the third-party risk management program as needed, including assisting in compliance reviews and approvals.
- Serve as the first line of communication to the business for reviewing local requests and documentation.
- Support and participate in compliance committees (and/or cross-functional groups) in coordination with Terumo Aortic's Compliance team as needed
- Assist in the preparation for Internal Audits
- Assist with other reasonable compliance-related activities, as requested from time to time
- 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 certification is also considered a plus.
- Proficient in SAP, Concur, Microsoft software (excel, PowerPoint, word), Power BI is a plus
- 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.
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Senior Compliance Specialist US - Sunrise, United States - Terumo Aortic
Description
Position SummaryThe Senior Compliance Specialist supports and assists in the development and implementation of the Terumo Corporate Compliance Program at Terumo Aortic.
This position is responsible for assisting the Head of Compliance and its designee(s) with the following tasks, among others:
Committee support, including review of grants applications, required interactions with applicants, the preparation and coordination of communications to applicants, template drafting and execution (signature) of agreements, maintenance of the grant log.
contract administration, including the template drafting and execution (signature) of agreements, maintenance of the HCP contracts database and other related activities.
in Sunshine Act reporting process, including the collection and reporting applicable data, ensuring timely and compliant submissions and remediationsthe implementation of testing & monitoring plan to demonstrate that the Compliance program is effective and participate in execution where appropriate.
party management, including assisting in the review of Third Party Due Diligences and approvalsAny other compliance related activity as may be required from time to time
Key Accountabilities
The Terumo Aortic Senior Compliance Specialist is responsible for assisting the Head of Compliance with the following key activities, including, but not limited to:
HCP Consultancy Agreements & Engagements:
Assisting in Compliance Reviews and approvals
US HCPs screening and recording
Support template contract management
Facilitate contract signatures process
Record of HCP agreements in contracts database.
1.2.
Medical Educational Grants and Donations:
Review Grants and Donations applications
Interact with Healthcare Organizations/ Institutions regarding the management of grants as directed (request additional info, manage contracts, etc.).
Support template contract management and facilitate contract signatures process
Keep Grants Database up to date.
1.3.
Support the implementation of testing & monitoring plans and participate in execution where appropriate, including:
Monitoring reports and analytics,
Proceed with investigation as action plan aligned with Compliance Team
Preparation of follow-up communications and corrective actions,
Monitoring log maintenance and update,
Policy training and re-training to associates as needed.
Support:
i) the implementation/roll out of Compliance policies and/or SOPs in compliance with Terumo Americas' (TAH) compliance framework, as well as ii) the education and communication initiatives to foster a culture of business ethics and provide practical guidance to employees to act ethically and in a compliant way, iii) the provision of internal and external training based on the training needs of the organization (and external stakeholders, if applicable), and measure the effectiveness of training.
This position requires cooperating and working collaboratively with different company departments, mainly Management, Legal, Sales, Marketing, Procurement, R&D, Clinical, and the other team members within the department across the United States and Europe.
Minimum Skills and Capabilities:
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.
Minimum Knowledge & Experience required for the position:
