Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Biosurgery and Endomechanical to be located in Cincinnati, OH or Raritan, NJ.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Medical Safety Officer (MSO) role is to provide medical safety stewardship for MedTech Surgery products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. The MSO is an active member of diverse cross functional teams, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for MedTech Surgery products as assigned by Senior Safety Officer. 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 Medical Affairs, R&D, Quality, Regulatory, Clinical, Epidemiology 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 trusted partner in the innovation process, engaging with R&D, Medical Affairs and quality engineering to drive MD and J&J Vision’s patient-centered innovation process. The MSO will have primary responsibility for Biosurgery and Endomechanical as part of MedTech Surgery.
Responsibilities include, but are not limited to the following:
- Assess product risk-benefit and provide medical input/review to:
- Risk Management Reports
- Health Hazards Evaluations
- Clinical Evaluation Reports
- Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families
- Review and provide input on Adverse Events, complaints, and mass communications.
- Review internal and customer safety training materials
- Input into design and interpretation of safety-related studies, and results of any SSP activities
- Evaluation of medical impact of manufacturing issues
- Clinical interpretation of:
- Post-marketing safety data
- Aggregate complaint data
- Individual case safety reports
- Literature reports with possible safety data
- Provide medical safety expertise, oversight, and guidance as it relates to the performance of products
- Contribute to and periodically review the definition of a product’s harms and hazards list and derivations of criteria for reportability
- Review and approve (from a medical safety perspective) appropriate reports and filings
- Advise on failure investigations and provide medical opinion when deciding on reportability
- Act as subject matter expert in audit and other regulatory body interactions
- Interface with customers/users to gather additional medical information/data when required to support investigations
- Review responses to, for example, regulatory bodies, clinicians, and patients when safety issues are involved
- 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.
- 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
- 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
- Participate with cross functional product development teams, advising on the safety/risk management of devices in development.
- Ensure appropriate metrics are used to assess adequacy of patient safety related processes.
- Deploy best practice in co-ordination with MD CMO
- Reports to Senior Safety Officer covering MedTech Surgery.
