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Manager, Medical Affairs - Clinical Development + a 5% Signing Reward

Company: Canon Medical Systems USA, Inc.
Location: Tustin
Posted on: December 6, 2019

Job Description:

Made for Partnerships. Made for Patients. Made for You. At Canon Medical Systems we partner with our customers to truly understand their needs in imaging and beyond. We develop a full range of imaging solutions, including CT, X-Ray, Ultrasound and MR that address time pressures, workflow constraints, patient comfort and imaging precision to deliver true efficiency coupled with best in class tools for diagnosis. Together, we work on an education plan and develop service solutions that meet your every needs.
Our goal is to work hand in hand with our partners to deliver optimum health opportunities for patients through uncompromised performance, comfort and imaging accuracy. Together, we make it possible. OVERVIEW Work as part of a dynamic and fast-paced team of clinical and technical experts dedicated to positively impacting clinical care by effectively translating innovative imaging solutions to the clinical environment. Generate scientific and clinical evidence via product evaluations and research in order to highlight advantages of the technology while maintaining alignment with the business strategy. Participate as a clinical expert of the product line technology and communicate product intelligence to internal teams and key partners, collaborators, and external experts. Effectively interact with multiple teams including R&D, global and local business, marketing solutions, regulatory, applications, and service. Manage key clinical customer/partner relationships in order to comprehensively support Canon's business objectives while serving the needs of patients. RESPONSIBILITIES

  • Clinical research and validation. Support collaborative research and clinical evaluation projects at collaboration/partner sites including data collection, protocol development, data acquisition, phantom studies, equipment evaluations, post processing, and development of presentations.
  • Provide evidence-based guidance on scientific and clinical requirements for new products and features to meet market needs.
  • Support regulatory activities by managing image quality review with external medical experts, providing clinical expertise, and reviewing study/test-plan design. Influence regulatory specifications and claims strategy by providing clinical consultation during early phase development.
  • Work with Strategic Development team to evaluate product claims from a clinical stand-point. Communicate relevant evaluation results via appropriate channels to internal and global research teams.
  • Manage, design, and execute internal and external product evaluations. Explore expansion of clinical use. Provide product validation results and communicate scientific and clinical benefits to company stakeholders such as Solutions Marketing for the purposes of product collateral development.
  • Support Solutions Marketing in developing collaterals. Provide relevant scientific and clinical data, review collaterals for clinical accuracy, and work jointly with regulatory to ensure adherence to clinical claims. Counsel Solutions Marketing on the development of clinical arguments for products and counter-arguments against competition.
  • Support education teams in development of videos and training programs by providing clinical expertise and evidence.
  • Support Clinical Collaborations in Medical Advisory Board (MAB) activities related to the product line.
  • Support Clinical Collaborations by actively participating in hypothesis-based research grant proposal review committees for all product lines.
  • Work with Clinical Collaborations database administrator to ensure research activities are kept to schedule and recorded on a regular basis.
  • Participate in BU and Medical Affairs meetings and provide clinical expertise to support business decisions.
  • Provide clinical, technical, and product education to enhance the knowledge base of the Market Development, Solutions Marketing and Applications teams.
  • Collaborate with healthcare economics personnel to translate economic benefits of clinical research programs for the benefit of marketing and sales programs.
  • Communicate known clinical or technical product issues via appropriate channels. Work with relevant team(s) (e.g., Strategic Development, Regulatory, and Service) to quickly implement market accepted solutions.
  • Perform all responsibilities in full compliance with regulatory and legal requirements, and within industry guidelines.
  • Support Applications to develop market-optimized protocols/sequences/presets and positively influence equipment optimization.
    REQUIRED KNOWLEDGE & SKILLS
    • Strong communication skills, including credible interaction with prominent physicians and demonstrated skill at writing and presenting.
    • Demonstrated project management and/or customer support skills.
    • Demonstrated understanding of current and emerging products and technology in product line.
    • Prefer detailed clinical and technical knowledge of product line technologies (CT, MR, X-ray UL or Vascular systems).
    • Proficiency with computers in windows-based software environment.
    • Proven ability to operate effectively in a matrix organizational structure.
    • This position will require 50% field based travel. REQUIRED YEARS OF EXPERIENCE
      • 8+ years of experience working with and operating the product line technology (MRI) in a clinical hospital, industry position, or clinical research setting.
      • 2+ years in supporting clinical investigations including scientific writing/editing
      • 2+ years clinical product development, marketing or sales experience preferred REQUIRED EDUCATION
        • BA degree or equivalent; certified as a registered technologist on product line technology (MRI)

          About usCanon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family.

Keywords: Canon Medical Systems USA, Inc., Tustin , Manager, Medical Affairs - Clinical Development + a 5% Signing Reward, Executive , Tustin, California

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