Medical Safety Officer Biosurgery

About the role

Johnson & Johnson is seeking a Director, Medical Safety Officer (MSO) - Biosurgery to join our team in Raritan, NJ. The MSO role focuses on providing medical safety stewardship for MedTech Surgery products.

Responsibilities

• 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.
• Evaluate medical impact of manufacturing issues.
• Contribute to and periodically review the definition of a product's harms and hazards list and derivations of criteria for reportability.
• Approve (from a medical safety perspective) appropriate reports and filings.
• 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.
• Review responses to, for example, regulatory bodies, clinicians, and patients when safety issues are involved.
• 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.
• 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 coordination with MD CMO.
• Report to Senior Safety Officer covering MedTech Surgery.

Requirements

• Minimum of 5 years’ clinical experience (after completion of residency) as a robotic surgeon in a specialty in which robotics is actively used i.e., general surgery (or subspecialties such as bariatric, colorectal etc.), thoracic surgery, urology or gynecology is required.
• Experience in risk evaluation and mitigation is preferred.
• Medical device and/or pharmaceutical industry experience is helpful.
• Clinical study/research experience is helpful.
• Experience of interfacing with senior leadership within a global healthcare company is preferred.
• A knowledge of basic statistical techniques.
• A knowledge of basic epidemiological principles.
• Advanced Microsoft Excel skills.
• Training or significant experience in Robotics.

Qualifications

• Doctor of Medicine (MD), Doctor of Osteopathy (DO) designation or equivalent, such as MBChB.