Johnson & Johnson Careers


Somerville, New Jersey; Cincinnati, Ohio
Drug & Product Safety Science

Job Description

Requisition ID: 5515190128

The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Medical Safety Officer located in Somerville, NIJ or Cincinnati, OH. 

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Medical Safety Officer (MSO) will:

  • Provide medical safety stewardship for Medical Device (MD) products.  Although a medically independent voice is key, collaboration in assessing potential safety signals is expected
  • Responsible as active member of a cross functional team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for an MD&D product.
  • Execute on the Medical Safety Organization’s strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Medical Officer
  • Build clear and strong relationships between R&D, Quality, Regulatory, Clinical, Epidemiology and Safety sciences and Safety process and groups to allow for proactive and flexible risk management system. The MSO is knowledgeable in risk management and serves as a subject matter expert in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life
  • Play a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety.  The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities which should be taken to minimize potential risk to patients. Further, the MSO must be a credible partner in the innovation process, engaging with R&D and quality engineering to drive MD&D’s patient-centered innovation process
  • Primary responsibility for one of the following areas in Medical Devices:  Global Orthopedics, Global Surgery, CSS or Consumer Medtech
  • Assess product risk-benefit and provide medical input/review to:
  • Risk Management Reports
  • Product Issue assessment/ Health Hazards Evaluations
  • Clinical Evaluation Reports
  • Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families
  • Clinical interpretation of Post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with possible safety data
  • Input into design and interpretation of safety-related studies, and results of any SSP  activities
  • Review and provide input on mitigations, labeling and internal and customer safety training materials directed to minimize patient risk and improve outcomes
  • Represent Medical Safety in various product reviews during development
  • Evaluation of medical impact of manufacturing and design issues
  • Provide medical safety expertise, oversight and guidance as it relates to the performance of products 
  • Monitor external sources/trends and identify and escalate emerging issues.  These include (but are not limited to), complaint & MDR/MDV trends, regulatory & market trends/intelligence, literature and scientific publications 
  • Review and provide input on Adverse Events, complaints and mass communications
  • Advise on failure investigations and provide medical opinion when deciding on
  • Reportability Interface with customers/users to gather additional medical    information/data when required to support investigations 
  • When required, review additional safety-related information to customers to prevent repeat adverse events and complaints
  • Discuss with healthcare professionals (at their request) AE investigations as well as discussion of AEs that the customer experienced 
  • Be the medical representative within the escalation process when making decisions on field actions and help evaluate the effectiveness of field safety corrective actions 
  • Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products 
  • Deploy best practice in co-ordination with MD CMO
  • Ensure appropriate metrics are used to assess adequacy of patient safety related processes
  • Contribute to and periodically review the definition of a product’s harms and hazards list and derivations of criteria for reportability 
  • Act as subject matter expert in audit and other regulatory body interactions
  • Review and approve (from a medical safety perspective) appropriate reports and filings
  • Review responses to, for example, regulatory bodies, clinicians and patients when safety issues are involved 
  • Coordinate with Regional Safety Officers to ensure timely coordination of information

  • A minimum of a Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree, such as MBChB required
  • Minimum of 3 years’ clinical experience required
  • Relevant clinical or research experience, or specific training related to the area of primary responsibility required
  • Ability to use common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint) required
  • Experience in risk evaluation and mitigation preferred
  • Medical device and/or pharmaceutical industry experience in Health Care and/or device industry preferred
  • Clinical study/research experience preferred
  • Experience of interfacing with senior leadership within a global healthcare company preferred
  • Knowledge of basic statistical techniques required
  • Knowledge of basic epidemiological principles required
  • Advanced statistical knowledge (e.g. multivariate data analysis) preferred
  • Knowledge of pre-clinical or clinical research concepts required
  • Knowledge of local and international Medical Device regulations preferred

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location
United States-New Jersey-Somerville-US Route 22 West
Other Locations
North America-United States-Ohio-Cincinnati
Depuy Orthopaedics. Inc. (6029)
Job Function
Drug & Product Safety Science
Requisition ID