Medical Safety Officer- Heart Recovery

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Danvers Massachusetts United States of America

Job Description:

Johnson & Johnson is currently seeking a Medical Safety Officer (MSO)- Heart Recovery Cardiac Surgery/Interventional Cardiology to be located in Danvers MA.

The 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 diverse cross functional teams and a close partner with the quality leader and statistical colleagues in assessing any potential safety signal for J&J MedTech products as assigned by Senior Safety Officer.

The MSO will execute on the Medical Safety Organizations 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 J&J MedTechs patient-centered innovation process.

The MSO will have primary responsibility for one or more companies within J&J MedTech

• Lead Safety Management: Chair the Safety Management Team (SMT) and oversee safety aspects of devices including benefit/risk profiles throughout the product lifecycle.

• Risk Management: Conduct risk assessments review clinical evaluation reports and develop safety surveillance plans. Provide input on risk management plans and post-market surveillance.

• Product & Clinical Oversight: Represent medical safety in product reviews approve safety content for labeling and oversee clinical study safety deliverables (protocols safety plans reports).

• Safety Data Analysis: Interpret post-marketing safety data complaints adverse events and literature reports. Advise on mitigations and safety communications.

• Stakeholder Collaboration: Work closely with Medical Affairs R&D Quality Regulatory and other cross-functional teams to ensure proactive risk management and patient safety.

• External Monitoring: Monitor regulatory market and scientific trends; interface with customers and health authorities as needed.

• Regulatory & Audit Support: Act as a subject matter expert in audits regulatory interactions and due diligence for acquisitions.

Required Experience & Education

• Degree: Doctor of Medicine (MD) Doctor of Osteopathy (DO) or equivalent (e.g. MBChB).

• Experience: Minimum 3 years clinical or research experience with relevant background in interventional cardiology or heart failure.

• Technical Knowledge: Familiarity with ISO 14971 basic statistics epidemiology and clinical research concepts.

• Skills: Strong communication stakeholder influence and proficiency with Microsoft Office.

Preferred Qualifications

• Experience with J&J Heart Recovery/Abiomed Impella Pumps.

• Background in risk evaluation medical device/pharma industry and clinical research.

• Knowledge of local/international medical device regulations and advanced statistical methods.

• Experience interfacing with senior leadership in global healthcare.

Required Skills:

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: $199000-$343275

Additional Description for Pay Transparency:

The anticipated base pay range for this position is: $199000-$343275 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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. 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 () or contact AskGS to be directed to your accommodation resource.