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

Direct, lead and oversee all Medical and Scientific affairs as they relate to the Clinical and Medical Affairs department and cross functional support.

Key Accountabilities:

1. Informational services: Lead the tracking, creating, and sharing information and knowledge relevant to products and specialty, developing and implementing publications plans, and the reporting of clinical results internally and externally, at scientific meetings and through journal articles. Oversee the maintenance of product and specialty information on a variety of databases, tracking this information and filing as appropriate.

2. Regulatory support: Lead, contribute and review written educational, technical, and promotional materials. Lead the input into the development of global clinical strategies, contribute to and advise regulatory submissions and documents. Lead and oversee the timely and appropriate completion of Clinical Evaluation Reports (CERs) for all TA products.

3. Health care professionals and professional organizations liaison: Lead the efforts of professional associations, HCPs to create and disseminate knowledge via the company’s scientific committee, developing and maintaining relationships with HCPs to disseminate knowledge better. Interface with physicians, learned societies, and scientific meetings organizers. Oversee the company’s scientific committee, investigator-initiated studies, and contribute to other committees (grants, publications, etc.) as required.

4. Marketing support: Lead scientific input and expertise in the design and construction of all promotional materials and events, contributing to increased knowledge and awareness with product-specific and general scientific knowledge and information. Attend and participate in scientific meetings, congresses and travel as required in the pursuit of these objectives.

5. R&D and clinical support: Lead and direct clinical development including study design, Biostatistics and Data Management, including via the provision of timely medical and scientific information. Contribute to and review clinical documents such as protocols, study reports, study materials, clinical evaluation reports and regulatory documents such as submissions.

6. Medical Affairs development: Lead the long-range strategy for the company. Lead the Medical Affairs team (and other subcontracted providers and vendors). Direct department team and resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.

7. Department wide: Lead, recruit and develop the teams within Medical and Scientific Affairs including by not limited to Medical Affairs, Medical and Scientific Writing, Data Management, and Biostatistics. Track and evaluate performance of teams.

Internal Networking/Key relationships:

This position requires cooperating with different company departments, such as Sr. and executive leadership, Sales, Marketing, Sales & Training, Clinical Operations, R&D, Logistics, Operations, Human Resources, Quality and the other team members within the department.

Minimum Skills and Capabilities:

• Excellent Written and Oral English
• Scientific and technical writing ability
• Cursory knowledge of biostatistics and data management
• Proficient in study design and scientific principles
• Solid understanding of the clinical investigation process and regulatory requirements including US FDA and EU regulations
• Solid understanding of MDR requirements
• Possess good interpersonal skills, self-motivated and retain a positive attitude.
• Extremely detail-oriented and organized, with excellent communication and administrative skills.
• Ability to lead and manage a team as well as working independently.
• Ability to learn new and diverse subject areas quickly.
• Familiarity (as a user) with medical information databases (such as PubMed)
• Strong mentoring and teaching skills
• Excellent problem solving, judgment and decision-making skills.
• Effective oral/presentation and written communication skills
• Excellent negotiation skills

Minimum Knowledge & Experience required for the position:

• B.S. or higher in health care/life sciences (advanced doctoral degree preferred)
• Applicable experience in clinical research (medical device is highly preferred)
• Experience in the cardiac, vascular or aortic space preferred
• Applicable experience managing or leading teams/individuals.
• Scientific and technical writing experience 
• Excellent computer skills, including expertise in Microsoft Office Products, such as Word. Power Point and Excel.

International Mobility:

Yes

Travel requirements:   

Up to 40%

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.