J&J Family of Companies Medical Safety Officer, Orthopedic in Warsaw, Indiana

DePuy Synthes, a Johnson & Johnson Family Company, is recruiting for a Medical Safety Officer, Orthopedic to be located in Warsaw, IN.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The Medical Safety Officer (MSO) role is to provide medical safety stewardship for Medical Device (MD) products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. The MSO is an 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 product.

The MSO will 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.

The MSO will 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.

The MSO plays 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.

The MSO will have primary responsibility for DePuy Synthes Joint Reconstruction.

Principal Duties & Responsibilities

  • 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

  • The MSO will 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.

Qualifications

  • A Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree, such as MBChB is required

  • A minimum of 3 years of Orthopedic clinical or research experience is required

  • Experience in risk evaluation and mitigation is preferred

  • Medical device and/or pharmaceutical industry experience in Health Care and/or device industry is preferred

  • Clinical study/research experience is preferred

  • Experience of interfacing with senior leadership within a global healthcare company is preferred

  • Advanced statistical knowledge (e.g. multivariate data analysis) is preferred

  • Knowledge of local and international Medical Device regulations is preferred

  • This position will be located in Warsaw, IN and may require up to 10% domestic and international travel

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-Indiana-Warsaw

Organization

Depuy Orthopaedics. Inc. (6029)

Job Function

Clinical Research MD

Requisition ID

4457180926