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Mgr Medical Affairs - Clinical Scientist Sr

Role overview

Qualifications

  • Experience in clinical research and validation
  • Technical expertise in scientific and clinical requirements
  • Strong communication skills for internal and external collaboration
  • Knowledge of regulatory affairs and industry standards

Responsibilities

  • Manage collaborative research and clinical evaluation projects
  • Provide evidence-based guidance on scientific and clinical requirements
  • Support regulatory activities and influence specifications and claims strategy
  • Communicate evaluation results to research teams and support marketing collaterals

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • Medical Affairs Manager
  • $132K – $238K / year
  • English

Hard skills

Other skills

  • Technical Acumen
  • Communication
  • Collaboration
  • Problem Solving

About the company

Canon Medical Systems USA, Inc. logo

Canon Medical Systems USA, Inc.

  • Large
  • 1,001–5,000
Mission Canon Medical Systems USA delivers innovative imaging solutions and services through our Made for Life philosophy to improve the quality of life for all people. Our Heritage Canon Medical Systems is born from two global leaders—Canon and Toshiba Medical. In business for more than 100 years, Toshiba Medical was built to improve the quality of life for all people. It delivered on this mission with medical innovations that are Made for Life—made to improve the lives of patients, clinicians and administrators. Its legacy was built with pioneering medical technology, such as the world's first X-ray machines in 1932 and Japan's first Magnetic Resonance Imaging systems (MRI) in 1983. Toshiba Medical’s vision was strengthened in 2016 with its acquisition by Canon. Canon entered the healthcare business in 1940 with the development of Japan’s first indirect X-ray camera which was used for the early detection of pulmonary tuberculosis. The partnership of these two companies (now Canon Medical Systems Corporation), brings together two cutting-edge technology businesses, founded with similar values of creativity, flexibility and patient-friendly healthcare solutions. Today, their combined history of research and innovation drive forward Canon Medical Systems’ vision for building a world-class healthcare enterprise.

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Job description

  • This is a remote position
  • Clinical research and validation. Manage collaborative research and clinical evaluation projects at collaboration/partner sites including data collection, protocol development, data acquisition, phantom studies, equipment evaluations, post processing, co-writing papers, IP and technology transfer support, 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 providing technical/market expertise, and reviewing study/test-plan design. Influence regulatory specifications and claims strategy by providing scientific and clinical consultation during early phase development.
  • Work with Strategic Development team to evaluate product claims and specifications -- including testing of default protocols to ensure acceptance by industry standards (e.g., The Joint Commission and ACR). Communicate relevant evaluation results via appropriate channels to internal and global research teams.
  • Support, 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 scientific accuracy, and work jointly with regulatory to ensure adherence to clinical claims and technical specifications. Support Solutions Marketing on the development of scientific and clinical arguments for products and counter-arguments against competition.
  • Support education teams in development of videos and training programs by providing clinical and technical 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 and technical 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 industry within guidelines.
  • Represent Canon as a spokesperson for product line technology at educational and scientific industry events.
  • Represent Canon in industry organizational activities (e.g., MITA, IEC, AAPM, RSNA, ISMRM, ACR, ABR, QIBA, etc.).
  • Pay Range $132K-$238K DOE

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