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Senior Medical Affairs Director, Robotics and Digital: Johnson & Johnson Medical Devices.

Company: Johnson & Johnson
Location: San Jose
Posted on: January 16, 2022

Job Description:

Johnson & Johnson Medical Devices is currently recruiting for a Senior Medical Affairs Director, Robotics and Digital based in Sunnyvale, CA.

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopaedics, endoluminal intervention and general surgery.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Senior Medical Affairs Director provides medical leadership to Ethicon's Robotics and Digital team, closely collaborating across Ethicon's platforms and focus on General Surgery.

The Primary Responsibilities Include

  • Act as a strategic partner with medical evidence generation colleagues in Preclinical Research, Clinical Development, and Health Economics Market Access teams to develop and execute global strategies for evidence generation for new and existing products to support regulatory approval/clearance, health technology assessment, customer access, and post-marketing support.
  • Safeguard patient safety.
  • Provide expert support to Regulatory Affairs, Communications, Legal, and Quality/Risk Management/ Product Safety teams. Contribute to risk management plans and failure mode analysis during product development and safety signal detection and post- market surveillance post-launch.
  • Participate or lead clinical scientific discussions with regulatory agencies / notified bodies to drive support of clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections.
  • Participate within the new product development R&D teams, by providing expert medical and scientific input, including conceptual and hands-on product evaluation, and clinical research perspectives. Drive the creation of 'Target Product Profile' documents that spell out the value proposition and potential claims of the desirable new product.
  • Participates as part of the Clinical, Medical and Pre-Clinical Evidence Team to achieve the strategic goals and activities of the function(s). Internally focused activities consist of pipeline engagement, clinical strategy, safety/surveillance and compliance, while externally facing activities aim to drive deeper and broader customer engagement and insight generation.
  • Provide support to New Business Development.
  • Provide scientific and medical perspectives for management of requests for Educational Grants, requests for Scientific Information, and requests for Investigator Initiated Research Grants.
  • Provide support to commercial teams by providing medical and scientific expertise to drive optimal business strategic direction and tactical business activities, including product launches, key scientific meetings, relationship management with leading research physicians and medical delivery system or government decision makers. Participate as an active member of the Platform Leadership Team, representing the Medical, Clinical and Pre-Clinical functions.
  • Provide critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.
  • Provide lifecycle medical affairs support (e.g. copy review, medical information requests, medical input into clinical evaluation reports, etc.).
  • Attend key Scientific Meetings, participating as an oral presenter. Write key scientific and clinical publications highlighting critical findings in the field and cementing role as Key Opinion Leader in the field.

    Qualifications
    • An MD/DO from an accredited school is required for this position. Training in a surgical discipline is required. x
    • Prior clinical experience and hands on experience with minimally invasive surgical techniques inclusive of robotic/digital surgery is required. Fellowship training in Thoracic Surgurg highly preferred.
    • Highly enthusiastic, self-motivated individual who will accept accountability.
    • Clinical research experience in medical devices, biologics, or drugs is strongly preferred.
    • Experience in support of global regulatory submissions for medical devices, biologics or drugs is desirable (including PMA/BLA/NDA and/or their global counterparts).
    • Experience in medical safety surveillance (drugs, biologics, or devices) and/or quality improvement activities is desirable.
    • Experience in the process of new product development (internal development and external partnerships) is desirable.
    • Demonstrated business acumen, leadership skills, mentoring skills. Ability to perform duties under general or minimal supervision.
    • Proven flexibility of attitude and mind set.
    • Ability to manage and embrace change.
    • Ability to build successful relationships with key opinion leaders and investigators in key business areas.
    • Ability to influence, shape and lead without direct reporting authority.
    • Ability to operate in a matrix environment and work across a complex organization.
    • Excellent communication, interpersonal, and reasoning skills.
    • Excellent communication skills, including written communication (e.g., peer review publication) and oral presentation of scientific materials and research results. Ability to write original scientific documents such as clinical summaries, regulatory filings, investigator brochures, and internal reports and scientific publications.
    • Teaching skills, including both oral and hands-on education of health care professionals and company employees on scientific and medical issues surrounding company products and on optimal safe and effective use of products.
    • The ability to travel up to 30% [ post Covid 19] to include domestic and international travel.

      Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

      Primary Location

      United States-California-Redwood City-150 Shoreline Dr

      Other Locations

      North America-United States-California-San Francisco, North America-United States-California-San Jose, North America-United States-California-Santa Clara, North America-United States-California-Sunnyvale

      Organization

      Auris Health, Inc. (6267)

      Job Function

      R&D

      Requisition ID

      2105909258W

Keywords: Johnson & Johnson, San Jose , Senior Medical Affairs Director, Robotics and Digital: Johnson & Johnson Medical Devices., Executive , San Jose, California

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