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Medical Senior Safety Officer, Robotics Digital and AI.

Company: Johnson & Johnson
Location: Cincinnati
Posted on: January 16, 2022

Job Description:

Ethicon: Medical, Senior Safety Officer Robotics, Digital and AI

Cincinnati, OH

Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products, and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.

As pioneers in medical devices, we continually focus on elevating the standard of care- working to expand patient access, improve outcomes, reduce health system costs, and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.

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.

The SSO role leads the medical safety function for the Group or assigned business area. The SSO will have oversight of safety investigations ensuring proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of the products within his/her area, and communication of potential and known risks, when appropriate, to Senior Management, Health Authorities, Prescribers and/or Patients. The SSO will further be responsible for ensuring alignment to sector Safety processes, policy, and procedures and J&J standards. The SSO oversees Medical Safety Officers (MSOs) in his/her assigned area and is responsible for ensuring they complete the designated training for medical safety (to be determined by MD Medical Safety Group), and training per the clinical competency model in accordance with their personal development plans. The SSO must be aware of resources needed to fulfill all medical safety obligations, and partner across the responsible functions to ensure any resource gaps are addressed expeditiously. The SSO is responsible for ensuring Medical Safety is the chair of the Safety Management teams (SMT) providing an independent medical perspective on medical safety. The SSO is a member of the Chief Medical Officer's Extended Leadership team, and a close partner with the quality leader for the assigned businesses. The SSO presents Medical Safety Issues to ORB. The SSO must collaborate with key stakeholders and champion the Enterprise Medical Safety Principles.

Learn more about Cerenovus at and follow us on LinkedIn.

We Are Looking For

Be a part of our FUTURE! We seek a leader of leaders who models the J&J Credo, is an outstanding communicator, intellectually curious, can learn our robotics platform quickly, and be up to speed on our medical safety function at JNJ in short order. We need an unbiased, results and safety driven person of passion who is ready to drive the post-market safety of our robotics and while creating strong surgeon relationships.

Model the Credo, Empower the Team, Shape Innovation, Exceed Stakeholder Expectations and a Healthier World Always!

Is this you? If yes, APPLY.

Key Objectives And Responsibilities

  • Oversee the assessments of product risk-benefit in partnership with the MSO: Risk Management Reports, Health Risk Evaluations, Clinical Evaluation Reports, and Product Safety Surveillance plans (SSPs), including risk categorization of product/product families
  • Ensure MSO input is provided to: Responses to AEs, complaints and mass communications, Internal and customer safety training materials, Design and interpretation of safety related studies, and results of any SSP activities, Evaluation of medical impact of manufacturing issues, Product's harms and hazards list and derivations of criteria for reportability, and Failure investigations
  • Serve as an expert resource to MSOs for the interpretation of post-marketing safety data, Aggregate complaint data, Individual case safety reports, and Literature reports with possible safety data
  • Supports MSC-Medical Affairs collaboration on product safety signal evaluations and investigations
  • Ensure all medical personnel (MDs, MSOs, regional MDs) in the assigned area understand their role in medical safety
  • Be the responsible medical safety representative at ORB for any product safety related escalations, partnering with Medical Director, MSO and Quality Risk management
  • Ensure consistency in medical evaluations, Quality Review Board decisions and overall safety evaluations of products
  • Ensure appropriate metrics are used to assess adequacy of patient safety related processes
  • Deploy best practice in co-ordination with MD CMO
  • Coordinate presentations to the MD Medical Safety Council for product safety issues for assigned products
  • Work in partnership with the MD Medical Safety group to enhance organization effectiveness, and support professional development for MSOs


    • Doctor of Medicine, (MD), Doctor of Osteopathy (DO) designation or equivalent, such as MBChB
    • 3+ years clinical experience in General Surgery
    • 10+ years of clinical, pharmaceutical and/or medical device experience
    • Experience in risk evaluation and mitigation
    • Experience in matrixed organizations
    • 2+ years of medical device and/or pharmaceutical industry experience
    • Clinical study/research experience
    • Experience interfacing with senior leadership within a global healthcare company
    • A knowledge of basic epidemiological principles
    • Statistical knowledge (e.g., multivariate data analysis)
    • Advanced Microsoft Excel skills
    • Training or significant clinical experience in Robotic Surgery

      • Experience in digital, robotics and AI medical device development

        Highlighted Benefits
        • Competitive and Equitable Compensation
        • Long Term Incentives (LTI)
        • Benefits such as health, vacation, holidays, personal & family paid time off etc.
        • Travel Health
        • Pension Plan

          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-Ohio-Cincinnati-4545 Creek Road


          Medical Device Business Services, Inc (6029)

          Job Function


          Requisition ID


Keywords: Johnson & Johnson, Cincinnati , Medical Senior Safety Officer, Robotics Digital and AI., Healthcare , Cincinnati, Ohio

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