J&J Family of Companies Global Medical Safety Officer in Skillman, New Jersey
Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Medical Safety Officer. The preferred location for this role is Skillman, NJ, but an alternate location of Fort Washington, PA may be considered.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
The Global Medical Safety Officer (GMSO) will support the Safety Stronghold Team Leader (SSTL) and serve as medical safety oversight of allocated Consumer products or product families throughout the product life cycle in close alignment with SSTL. This individual will ensure communication of potential and known risks, when appropriate, to direct management, the Consumer Qualified Person for Pharmacovigilance (QPPV), and personnel in all other relevant functional areas. Functions as integration alliance manager under the SSTL leadership and in close relationship with cross-functional areas ensures early involvement, oversight plan and execution of safety integration process to enable proper and timely end to end safety integration of new companies/product due diligence and acquisitions. When necessary, act as on-site medical safety representative liaising with integrated company and SSTL to ensure effective communication, proper oversight and support to guarantee successful launches in compliance with Safety Standards. In collaboration with, and at the direction of the SSTL, the GMSO will also support and/or contribute to the development of safety assessments and risk management. Work in a cross-functional matrix environment and liaise with Medical Affairs (MA), Regulatory Affairs (RA), Research & Development (R&D), Toxicology, Quality Assurance (QA), Commercial, and Legal to ensure accurate assessment of the safety information for assigned products.
Provide safety expertise and decisions to Labeling Working Groups (LWGs), including review and endorsement of new safety information in new/revised company core data sheets (CCDS), in accordance with applicable procedures.
Provide input into aggregate safety reviews and advise on the appropriate strategy for Benefit/Risk Evaluation and participate in appropriate Risk Management activities (e.g. Product Risk Management, Risk Management Plan).
Regularly review results of all available data from external and internal sources, spontaneous adverse event reports, and cumulative data from non-spontaneous (solicited) sources, provide medical clinical expertise for causality assessments and reporting of data and assessment results to internal (e.g. Study Management Team) and external stakeholders (e.g. Health Authorities).
Provide documented medical safety input for product quality issues. Communicate any safety signals/issues that have a potential quality component arising during evaluation of medical safety issues to Quality and Compliance (Q&C), or those without a quality component, but may require market action to the Quality Review Board (QRB).
Provide medical safety input and oversight of preparation of responses to safety related queries from Health Authorities (HAs). Make decision if initiation of a prompt communication to patients, health care professionals (e.g. Dear HCP letters), and HAs are required, and provide medical input to such communications.
Give strategic guidelines for how Consumer safety should support Medical Affairs. Review framework for appropriate representation during safety-related regulatory inspections and internal quality assurance/corporate compliance audits. Proactively provide strategic leadership role in organizational strategy, goals, and objectives for Office of Consumer Medical Safety (OCMS).
Ensure strategic insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols. Oversee approval of safety-related content for press releases and other public and professional communications.
Apply industry-leading operational strategy and criteria for appropriate escalation of safety-related issues and remedying actions. Provide final decision-making for rollout and implementation of new safety initiatives.
Initiate escalation of safety signals/issues, including those requiring a field action, to the Consumer Medical Safety Council (MSC) and senior management as appropriate. Coordinate with cross functional team to prepare and present new product development programs to Consumer MSC.
Act as safety-related point-of-contact and thought partner for all business partner activities. Apply a systematic approach to identify and manage risks to maximize the benefit-risk or safety profile of the product, as appropriate for product type, throughout a product’s lifecycle. Review and manage the evolving safety profile of products during the product lifecycle. Safety Surveillance, Signal Detection, and Labeling. Proactively ensure R&D safety insights and appropriate regulatory information and conclusions are applied to Quality and Commercial decisions.
Provide input into the product development process and throughout the product lifecycle (e.g. through formal approval during design reviews, stage gate reviews).
Medical Doctor (MD/DO) degree is required.
A minimum of 4 years of clinical practice experience, including a residency program or equivalent is required.
Must have demonstrated skills in clinical medicine.
A minimum of 3 years of experience in medical safety, drug safety, pharmacovigilance and/or medical affairs within the Consumer, Pharmaceutical and/or Medical Device sectors is required.
Experience in safety inspections and understanding of global safety regulations preferred.
Basic understanding of drug development, pharmacology, clinical trial methodology and design, and assessment of drug benefits vs. risks is required.
Knowledge of biostatistics is preferred.
Knowledge of epidemiology is preferred.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is preferred.
Must have excellent verbal and written communication skills.
The ability to critically evaluate safety data from multiple sources (clinical trials, post-marketing, and literature, etc.) is required.
The ability to collaborate, influence and negotiate with both internal and external stakeholders.
This position will require 10% travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Skillman-199 Grandview Road
North America-United States-Pennsylvania-Fort Washington
Johnson & Johnson Consumer Inc. (6101)
J&J Family of Companies
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