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Senior Compliance Specialist US
3 months ago
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.
www.terumoaortic.com
Position Summary
The 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:
* Grants 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.* HCP contract administration, including the template drafting and execution (signature) of agreements, maintenance of the HCP contracts database and other related activities.* Assists in Sunshine Act reporting process, including the collection and reporting applicable data, ensuring timely and compliant submissions and remediations* Support the implementation of testing & monitoring plan to demonstrate that the Compliance program is effective and participate in execution where appropriate.* Third party management, including assisting in the review of Third Party Due Diligences and approvals* Any 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:
1.- Management of key HCP related compliance processes, controls and monitoring and testing activities such as:
1.1. 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.* 2. Support Sunshine Act reporting process, including collection and reporting of applicable data ensuring timely and compliant submissions and remediations
3. 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.
4. Support the third-party risk management program as needed, including assisting in compliance reviews and approvals.
5. Serve as the first line of communication to the business for reviewing local requests and documentation.
6. Support and participate in compliance committees (and/or cross-functional groups) in coordination with Terumo Aortic's Compliance team as needed
7. Assist in the preparation for Internal Audits
* 8. Assist with other reasonable compliance-related activities, as requested from time to time
* Minimum Skilles
* 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.
* Internal Networking / Key relationships
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.
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.
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