Job Summary:This position is responsible for managing specialized projects with our cross functional partners including but not limited to; marketing, engineering, PACE, SMBD, Regulatory and Quality, elements of Medical Affairs, and other related areas of TMC. Provide support, education, training, and insight in the proper use of specialty medical devices in specific diagnostic and interventional procedures. Possess the ability to proctor physicians and/or ancillary staff in procedures where these devices are utilized, provide in-services and presentations on technologies, medical devices and on specific procedures to customers. Customers typically include physicians, nurses, and other medical and ancillary medical personnel.This position also provides highly specialized technical training in a clinical and/or surgical environment. Collaborates with internal teams on the research, development, implementation and maintaining of product training support, materials, programs and initiatives.Job Details:Provide clinical and technical insight across business units related to new product development, product life cycle management, marketing, engineering, training, regulatory and quality, and other areas of TMC. Deliver training and education of internal and external customers related to use and practical applications, support initiatives, and focus alignment between internal and external customersServe as a company liaison with customers on clinical and technical matters supporting company initiatives to meet organizational objectivesProvide support for organizational objectives where end user representation or clinical input is required through organized activities around new technologies and product life cycle managementSupport Product development and launch teams from concept through commercialization with training, customer feedback, and market surveillanceProvide clinical insight on new technology, mergers, and acquisitions through internal or external developmentProvide support to engineering, quality and regulatory in medical device surveillance, labelling, protocol development, packaging, design history files, among other commercial activities.Provide support for noncommercial activities that link current practices, trends, and technologies to TMC initiatives. Develop and manage processes to work collaboratively within the Clinical Services Group to align resources to the management of special projects, research, development and implantation of team strategies, tactics, goals and objectivesCollaborate with other business units to address clinical and technical issues and support of strategies and tacticsResponsible for linking appropriate clinical applications to all marketing strategiesClinical services group pillar lead for strategic marketing alignmentsManage and maintain appropriate communication and field support with internal and external customers for TIS products in conjunction with marketing teamProvide insight into current and emerging practice, technology, and trends to communicate to the field teamsLink customers with innovative technology, product concepts, or technical solutions to the appropriate business unitsWork with Human Resources to construct and implement new training programs within the FCS groupEnsure schedules are compatible with the clinical training needs of the BU and customer baseAssist with financial inputs during the annual Clinical services Group budget planning process Resolve clinically related customer problems and ensure clinical compatibility between all BU products and within the scope of procedural applicationManage, schedule and coordinate visits with customers to evaluate products and maintain good customer relationships, gain competitive knowledge and new product concepts or product enhancement ideasParticipate in team meetings as the clinical representative for TIS to provide ideas, methods, or processes, for TIS performance improvementDemonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not limited to the prompt recognition and forwarding of customer complaints (i.e. adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (i.e. branding strategies, product claims, etc.) and materials (i.e. literature) discussed or presented to customers are clinically accurate and adhere to AdvaMed guidelines and Terumo's policy on Interactions with Healthcare Professionals. Maintain strong knowledge of and adherence to regulations regarding promotional material content and control. Follow procedures for good clinical practices and Design Control when participating in new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the TMC Quality System and Terumo's policiesPerform other job-related duties as assigned.Working Conditions: This is a field-based position. Must be able to drive personal automobile to/from customer accounts and drive long distances as necessary.This position requires approximately 65% overnight travel. In addition, occasional weekend travel is required.This position requires regular travel to customer sites, TMC sites, tradeshows/congresses, and 3rd party sites to participate or conduct meetings.International travel may be required.To keep abreast of current technical trends and procedures, daily entry to hospitals and other medical facilities may be required. Many facilities have instituted vendor credentialing policies which require vendors to meet defined training, background check and proof of immunization requirements as a condition of entry. Terumo Associates entering these facilities are required to abide by these credentialing requirements.Must be able to gain access to and work in the IR suite, cath lab and operating room. Entry into these areas requires an ability to wear appropriate gowning, stand for long periods of time, comply with hospital policy/protocol and be aware of potential biohazards such as blood borne pathogens.Position Requirements:Knowledge, Skills and Abilities (KSAs) Thorough knowledge of company products and their recommended use Ability to handle customer/client inquiries and to respond with company information, selected reference material and analyze product applications and misapplications to diagnose product issues relating to usage, manufacture and/or failure Strong interpersonal and analytical skills, training, and the ability to stay abreast of the current technology, company products and generally accepted medical practices related to products and procedural area Ability to handle several time constrained projects simultaneously, while educating and satisfying the customerBackground Experiences Position requires a bachelor's degree in Health Care area or related science, technical/or professional health services licensure (RT, RCIS, RN) and a minimum of 6 years' experience in clinical or field support management or equivalent combination of training, education and relevant experienceMinimum of 4 years direct experience in the endovascular field with emphasis in peripheral vascular or cardiology focused medical device company preferredExperience in product life cycle management, design history, product support specialist required
Job Title
Sr. Field Clinical Advisor