Support NAMSA’s MRO activities and serve as a scientific technical and/or strategic consultant to clients at their request. Examples include the following types of projects:
Collaborate with clients to develop product development strategy, improve corporate performance, target new product lines, and implement change management or operational improvement from idea through implementation.
Support clients in developing clinical, scientific, and/or regulatory strategies and contribute to interactions with global regulatory agencies. This could include, but is not limited to, FDA (including advisory committee preparation), pre-submission meetings, and assisting with strategic approaches regarding the use of data.
Identify and utilize specialized experts for up-to-date experience, and managing client expectations for global projects including the strategic decisions, schedule, cost and quality of our services.
May act as the Program Manager for MRO programs as needed.
Understand and seek additional knowledge of all NAMSA business segments to be able to advise clients on the full scope of NAMSA services.
Prepare written documents including protocols, final reports, SOP’s, worksheets and other associated documents. Review and sign protocols and reports for studies.
Advise senior leaders and Associates in all NAMSA divisions on technical and scientific issues related to NAMSA’s global competencies.
Serve as key liaison with clients, including communications in critical and high-profile discussions with upper and executive level management.
Understand the complexity of multiple moving pieces within the project execution, motivate the team and collaborate with the client to adjust plans in order to optimize performance.
Act with flexibility, transparency, and proactively mitigate business and project risks.
Effectively achieve high quality and successful project completion.
Persuasively influence clients and internal stakeholders regarding scientific and/or strategic aspects of project support.
Travel approximately 30% of the time
Commercial Duties and Responsibilities
Directly support sales and marketing with client visits, industry trends for targeting and expanding opportunities developed by sales, with particular focus on MRO program and multi-product or service offerings.
Participate in meetings with prospective clients.
Provide scope of project and relevant information to support the creation of proposals.
Identify opportunities to bring in new projects and strategic partner clients.
Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
Speak at conferences, webinars, or other venues.
Attend technical conferences, governmental or standards meetings.
Actively seek out new business opportunities through speaking, networking, and thought leadership activities that directly result in new business for NAMSA across all MRO service offerings.
May represent NAMSA on external standards committees (e.g., AAMI, ASTM, ISO, and USP).
Master’s degree or doctorate in scientific or business discipline strongly preferred.
Product Development Strategist : At least 5 years of relevant experience in providing high level strategic direction with respect to regulatory agency interactions and/or leading areas of product development effort
Senior Product Development Strategist: 8 years, with at least 2 years of experience setting strategy
Principal Product Development Strategist: 15 years, including a minimum of 5 years of experience at a strategic level
Telecommuting is allowed.
Internal Number: 1848
NAMSA is a global medical device research organization providing a comprehensive range of services to prove efficacy, non-clinical and clinical safety of medical devices, IVDs, HCT/P and combination products. NAMSA has breadth and depth in consulting, non-clinical and clinical services with expertise in cardiovascular, orthopedic, ocular, neurologic, gastroenterologic, urologic, combination product and related medical devices. For more than 50 years, NAMSA clients utilize its testing and consulting services to bring safe and effective products to market.