Terumo Medical Corporation

Learning and Development

• Evaluate and develop training for all associates in Terumo Interventional Systems (TIS).
• Develop, maintain, and execute product and clinical training curriculums.
• Deliver approved clinical and product messaging via e-learning, self-study, computer-based training assessments, classroom, and virtual training.
• Partner closely with sales, field clinical, marketing, and medical affairs.
• Apply project management techniques to ensure project completion on-time and within budgets.
• Design and develop clinical and product training for new hire training and various training sessions.
• Assess organizational needs and align training strategies based on those needs.
• Lead competency certification for clinical and product knowledge.
• Evaluate the effectiveness of training programs and materials.

Senior Professional & Clinical Training Manager

Product Manager

• Responsible for all traditional marketing deliverables such as business plans, pricing, product positioning, promotional strategies, life cycle plans
• Advising on product improvements and new product needs for an assigned product portfolio and/or therapeutic area(s)
• Developing, implementing, and executing effective marketing strategies and tactics to ensure that products achieve revenue and operating profit targets
• Build partnerships with sales teams, clinical team on education and marketing programs, and develop relationships with key opinion leaders
• Ensure uninterrupted product availability, high quality and proper promotional efforts
• Manage existing portfolio and focus on new product development including product launches, sales training & education, and execution of commercialization plans

Senior Product Manager – Cardiology

• Responsible for all traditional marketing deliverables such as business plans, pricing, product positioning, promotional strategies, life cycle plans and advising on product improvements and new product needs for Terumo Interventional Systems (TIS)
• Developing, implementing, and executing effective marketing strategies and tactics to ensure that products achieve revenue and operating profit targets
• Building successful partnerships with sales teams, developing relationships with key opinion leaders and modifying strategies and tactics
• Managing an existing portfolio and focusing on upstream activities and new product development
• Supporting sales education and communicating with the sales force regarding product updates and availability
• Representing marketing/customer on new product development teams to support the business

Senior Product Manager

Customer Support

• Provides input as a clinical SME on key study documents, including Protocols, study plans, Investigational Brochures, and Information for Use, to support study success and ensure quality outcomes.
• Supports the development of and compliance to study specific Clinical Support Plans (CSP), Investigational Product Management Plan (IPMP), Clinical Training Plan, and other study plans as assigned.
• Assists in identifying and assessing potential clinical investigators for clinical study participation, managing sites through feasibility, qualification, and site selection.
• Supports study activities at the site, including site selection, Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), procedural support including protocol eligibility, query resolution, and ensuring accuracy and timeliness in core-lab imaging requirements, including upload processes.
• Assists in development & implementation of CSS and Physician device training/certification programs for assigned clinical studies.
• Provides clinical and technical support to Investigators and research staff, ensuring strict adherence to protocol, including eligibility during case support, regulatory compliance, and the efficient conduct of study operations as well as guidance with Terumo products, reporting device complaints when appropriate, within company guidelines.
• Develops and implements tools to track and analyze trends at sites and across the study including site-specific recruitment, patient screening and enrollment metrics, investigational device use/errors, ordering, and additional site metrics as needed.
• Assists in the collection, analysis, and interpretation of clinical data, gaining valuable insights to drive continuous improvement in study data accuracy and compliance with protocols.
• Contributes to the development and refinement of disease state training materials to strengthen internal team expertise, ensuring effective support for investigational product clinical studies and procedures.
• Collaborates with cross-functional teams to ensure adherence to study protocols, regulatory guidelines, and industry standards throughout the duration of clinical trials, including GCP, ICH, and FDA guidelines.
• Leads monitoring and tracking of strict medical device transaction accountability at the site and study level to ensure accurate fulfillment and consumption of investigational products. This includes completing timely quarterly investigational product reports for required study compliance.
• Executes accurate and timely clinical study deliverables with increasing independence while providing support to junior staff as needed, and for presenting periodic status reports on assigned clinical studies during regular team meetings and stakeholder meetings.

Clinical Support Specialist II

• Manage sales orders received by phone, fax, email and electronic data interchange (EDI).
• Take customer calls and provide accurate, satisfactory answers to their queries and concerns.
• Partner with the field, inside sales teams, and warehouse to meet and exceed all service expectations.
• Recognize a customer complaint and forwards to the appropriate personnel based on TMC’s Quality Policies and Procedures.
• Address and resolve customer’s service inquiries or issues by identifying the issue; and address or escalate to ensure resolution.
• Complete the field based inventory order processing.
• Verify customer pricing and process special instructions for handling.
• Process Return Merchandise Authorizations (RMA) in a timely manner to ensure customer satisfaction.
• Research and review warehouse shipping discrepancies with customers/sales and advise steps that will be taken to resolve problem.
• Work with the Accounts Receivable Team for timely resolution of order discrepancies.
• Release standing orders in accordance with pre-determined shipping dates.
• Gain product knowledge by utilizing the Knowledge Tree application.
• Perform other job-related duties as assigned.

Customer Care Representative

Account Manager

• Identify and pursue opportunities to develop new business to achieve designated sales quotas.
• Assist physicians with case planning to determine appropriate patient selection, device selection, and clinical support, including diagnostic imaging analysis and pre-implant strategy for aortic cases
• Train customers on the safe and efficacious use of the Company’s products
• Provide technical explanations and product demonstrations to customers, as well as intra-operative support.
• Manage backorders and customer satisfaction issues.

Territory Manager – Aortic

Events

• Review complaints to confirm reportability meets Regulatory reporting requirements. Provide comments and suggestions as needed and follow-up with team members on request for additional information to ensure accurate and complete submissions.
• Manage information requests as received from GHA's. Coordinate request for information and manage timelines with other departments, including engineering and quality to ensure requested information is accurately provided per required timeline.
• Continuously reviewing complaints status and updating file with progress and information findings to ensure all required information is submitted to the appropriate regulatory agency in a timely manner.
• Communicate with internal global subject matter experts and affiliate factories keep up to date on each countries' health authority requirements and to ensure reporting requirements and deadlines are met.
• Maintain MDR log to ensure all reportable events are captured and reported per regulation.
• Peer review MDR, Vigilance and MDPR reports prior to submission.
• Maintain adverse event files electronically to support compliance with regulatory requirements as well maintain compiled MDR files submitted on behalf of 'outside United States' (OUS) Affiliate factories.
• Perform cross-training with Complaints Specialist and others on adverse event reporting for MDR, Vigilance and MDPR.
• Attend training to enhance product and PMS&V knowledge.
• Provide reported MDR case data to Affiliate factories monthly
• Review & draft proposals to implement changes to the Quality System procedures/forms as needed to maintain compliance, improve effectiveness, & efficiency. (participate in process improvements throughout scope of role)
• Assist with third party/regulatory audits (Customer, Notified Body, FDA)
• Monitor and remain current with internal company procedures/policies, international QS standards and federal regulations.
• Assist the Manager, Product Complaints with tasks such as FDA correspondence, occasional customer complaint calls and maintaining communication with all domestic and overseas Terumo facilities.
• Performs other job-related duties as assigned.

Adverse Event Reporting Specialist II, Temporary

Engineer

• The Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), EU MDR, and other regulatory guidelines
• Drives all complaint investigation activities with cross functional team members and prepares complaint investigation reports, assigns test on retention, and returned samples and writes customer letters
• Assists the Team Lead or Manager to improve complaints and post market processes and procedures to generate efficiencies
• Provides support, assistance, and training for team members under guidance and direction of the Team Lead/Manager with regards to the overall complaints engineering process
• Responsible for engineering evaluation of returned products and trending analysis, in accordance with Terumo Medical Corporation procedures, and regulatory requirements
• Will interact with medical professionals, marketing, customers, customer service, clinical, regulatory, R&D and management to support in the complaint investigation process
• Promotes a work environment of continuous improvement that supports Terumo Quality Policy, Quality System, and the appropriate regulations
• Accountable for compliance with applicable US and International regulations and directives; including, but not limited to Food & Drug Administration (FDA), Canadian and European Union Medical Device Regulations (EU MDR) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV)
• Works with the adverse event reporting group and the complaints intake group to ensure accurate, and timely generation of Medical Device Reports (MDRs) and Vigilance Reports as required
• Responsible for compilation of Post Market Safety Update Reports (PSUR) required per EU MDR for the assigned product lines or as directed by the Manager
• Ensure that the team and organizational key performance indicators and metric targets are achieved and sustained by successfully collaborating with all parts of the PMSV function and where needed, greater QA function
• Collecting timely follow up information related to complaints from customers; typically, through the Sales and/or Field Service groups
• Collaborate in assessing Adverse Event Reportability decisions in accordance with US and International regulations
• Act as Post Market Surveillance Subject Matter Expert for assigned product lines which includes having expert knowledge about product design, manufacturing, complaint rates, complaint trends, reportability, risk and failure modes
• Responsible for driving all complaint investigation activities with cross functional team members, prepares complaint investigation reports, conducts objective testing and product analyses on returned samples and writes customer letters
• Convenes Complaints Trending meetings per Terumo procedures, manages data and information presentation for maximum dissemination of value-added information
• Documents meeting minutes in detail and follows up on all action items and ensures their eventual closure
• Responsible for presentation of engineering failure analyses on returned complaint product at complaints trending meeting and other forums
• Perform retention, decontamination and testing of returned devices
• Perform data analysis, additional testing, simulation testing, and root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety
• Ensure timely, accurate and complete complaints and failure investigations of returned products
• Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries
• Works independently and with different parts of the organization to resolve complex issues
• Responsible for communicating business related issues or opportunities to next management level
• Investigation and documentation of field clinical events and assist in the follow-up with Field staff
• May be required to perform customer visits to support in the investigation of critical issues and customer concerns
• Maintenance of complaint handling site procedures
• Gathers and reports various complaints metrics
• Presents critical information at Business Reviews
• Analyzes and trends Complaint data monthly to identify new and/or systemic issues as necessary
• Design and distribute data reports for management to facilitate communication and understanding of systemic issues
• Prepares responses to customers and field as necessary per process
• Stays current with all required training
• Provide engineering expertise in the installation, validation, and qualification of Complaints Investigation Test equipment which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment
• Assists with area layouts, flow analysis and procurement of equipment
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required
• May coordinate with Clinical Affairs in handling of clinical sample investigations

Complaints Engineer II – Temporary, 6 months

• Responsible for selling and promoting Terumo Interventional Systems (TIS) products to Interventional Radiologists, Interventional Cardiologists, Vascular Surgeons and Purchasing/Materials Management
• Achieve assigned monthly, quarterly and annual sales revenue targets
• Develop and implement appropriate sales strategies and techniques to target appropriate customers
• Conduct effective sales and product presentations to customers
• Educate customers to ensure products are understood and used effectively
• Develop and maintain comprehensive clinical and technical product knowledge of Terumo's products and competitive products
• Attend, support and in-service during endovascular procedures
• Maintain and grow existing business and develop new business opportunities
• Identify and quickly respond to competitive threats within the territory
• Communicate market intelligence/competitor activity promptly to Region Manager
• Conduct in-services to educate customers on the proper use of Terumo products
• Maintain compliance with all TMC Quality Systems requirements

Territory Manager – TIS

• Perform a variety of engineering assignments to meet quality standards in the most cost efficient manner
• Support manufacturing activities to meet established goals
• Accountable for equipment maintenance, setups & troubleshoot
• Manage projects which include new production equipment, process improvements and cost reductions
• Responsible for writing, executing and approving equipment/process qualifications
• Perform investigations of equipment and process issues to identify root cause and implement controls

Senior Manufacturing Engineer

Business Analyst

• Serve as the subject matter expert for providing analytics across the TMC Commercial Excellence (ComEx) team
• Design, develop, and maintain the Power BI platform
• Support business needs and decisions within commercial excellence
• Partner across the Contracts and Analytics team to assess needs, address process gaps, and help build efficiencies
• Create innovative reports, views, dashboards, scorecards, and visualizations using Power BI
• Drive requirements gathering, developing KPIs, and metrics

Senior Contracts Business Analyst

• Call on current and potential customers to promote and sell TIS products to achieve assigned monthly, quarterly and annual sales revenue targets.
• Develop and implement appropriate sales strategies and techniques to target appropriate customers, understand and confirm needs, overcome objections and gain commitment.
• Conduct effective sales and product presentations to customers.
• Educate customers to ensure products are understood and used effectively.
• Develop and maintain comprehensive clinical and technical product knowledge of Terumos products and competitive products including a thorough understanding each products features, strengths and appropriate usage.
• Attend, support and in-service during endovascular procedures.
• Maintain and grow existing business and develop new business opportunities.
• Identify and quickly respond to competitive threats within the territory.
• Communicate market intelligence/competitor activity promptly to Region Manager.
• Develop and maintain good customer relationships, through personal visits/telephone.
• Conduct in-services to educate customers on the proper use of Terumos products.
• Interact with Customer Administration, Logistics, Marketing and Technical Support to provide total customer satisfaction.
• Exhibit excellent leadership and teamwork amongst peers and others in the organization through the sharing of best practices and customer feedback.
• Serves as a role model to other Territory Managers and may be responsible for mentoring and/or training new associates.
• Provide assistance in the development of existing associates who are in need of additional training as determined by their direct manager.
• Proactively partners cross-functionally on initiates with impact beyond their local territory (i.e. national).
• Successful completion of 4 assigned MBOs in the areas of Performance, Leadership, Teamwork and Business Acumen.
• Respond to requests from field sales, marketing and training as a subject matter expert. Provide detailed documentation back to the organization requesting his/her expertise.
• May contribute to organizational planning including M & A and new product launches.
• Collaborate with Marketing and Training & Education in the development of Training sites and proctors.
• File weekly reports, monthly reports, competitive product reports, etc. in a timely manner.
• Attend trade shows and conventions to promote TIS products.
• Demonstrate a commitment to patient safety and product quality by maintaining compliance with TMC Quality Systems requirements.

Executive Territory Manager

Clinical Operations

• Support the development of project related deliverables including the project management plan, overall clinical budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc.
• Responsible to develop of study related documents, including protocol, informed consent, IB, regulatory binder, training materials, etc. and provide input to case report forms.
• Responsible to manage and track the overall study budget, track and administer payments, and provide financial updates.
• Responsible for the proactive management and conduct of clinical trials.
• Provide centralized site support, communication and coordination to assure timely completion of start-up, enrollment and all other study activities.
• Assist in the review site visit reports and enrollment progress and monitors the study for protocol, federal, and local compliance.
• Support vendor selection process, including RFP to contract and change order process for CROs and other external service providers (ESP).
• Provide day to day management of ESPs ensuring quality deliverables and adherence to the scope of work;
• Manage clinical supply shipments and inventory.
• Ensure compliance with Terumo policy, procedures and SOPs, GCP, and local, regional and federal regulations.
• Provide periodic updates, reports, etc. as requested.
• Manage ongoing communication of operation issues and provides progress reports to the study team.
• Assist with Database freeze, Database lock, annual progress reports, and final clinical study reports.
• Responsible for Site Management and Monitoring as required.

Clinical Project Manager

Compliance

• This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects
• define information and actions necessary to meet requirements.
• prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide.
• Serve as a liaison between Regulatory Agencies and Terumo Medical Corporation.
• Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.
• Participates on product design teams and verifies compliance with design control requirements and procedures.
• Maintain documentation and a historical record for projects and provide management with updated product status.
• Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance.
• Assist external customers by supplying materials and documentation for US and International product registrations as well as certification of appropriate US commercialization status.

Regulatory Affairs Specialist

Support Engineer

• Oversee the daily performance of computer systems.
• Set up equipment for employee use, performing or ensuring proper installation of cables, operating systems, or appropriate software.
• Assist in supporting general IT infrastructure (computers, storage, network, etc.).
• Provide end user support of all IT managed systems and applications.
• Work independently to resolve prioritized requests while maintaining accurate and thorough documentation, complete ticketing history to document analysis, diagnosis, and resolution plus future preventive actions.
• Install and perform minor repairs to hardware, software, or peripheral equipment, following design or installation specifications.
• Follow a prescribed trouble-shooting methodology to resolve customer requests consistently and efficiently.
• Modify and customize commercial programs for internal needs.
• Recognize and documents recurring problems and patterns of problems within the environment.
• Appropriately determine when to escalate to the next level of support.
• Create and maintain knowledge procedures.
• Provide on call support as part of a rotating schedule.
• Ensure compliance with all Terumo procedures including all applicable regulatory agency requirements.
• Contribute to a positive work environment by fostering open communication with team members, other departments, and management, promote teamwork, and commitment to excellence.