Medical Safety Officer Biosurgery

Job description

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Product Safety Job Sub Function: Product Safety Risk Management MD Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently seeking a Director, Medical Safety Officer (MSO) - Biosurgery to join our team located in Raritan, NJ. The 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 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. Required Minimum Education: Doctor of Medicine, (MD), Doctor of Osteopathy (DO) designation or equivalent, such as MBChB Required Years of Related Experience: 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 Training and significant experience in Surgical Robotics Required Knowledge, Skills and Abilities: A knowledge of basic statistical techniques A knowledge of basic epidemiological principles Advanced Microsoft Excel skills Training or significant experience in Robotics Required Skills: Clinical Experience, General Surgery Preferred Skills: Clinical Operations, Compliance Management, Compliance Risk, Data Gathering and Analysis, Developing Others, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing The anticipated base pay range for this position is : The anticipated base pay range for this position is: $199,000 - $342,700 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insu