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**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 insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.