Director, Safety Stronghold Lead

Johnson & Johnson Consumer Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a **Director, Safety Stronghold Lead** preferably located in Skillman, NJ; alternatively in Fort Washington, PA or Sao Paulo, Brazil.

Johnson & Johnson Consumer Inc. 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.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people

The Stronghold Safety Lead (SSL) in the Safety Surveillance and Risk Management (SSRM) function of the Office of Consumer Medical Safety (OCMS), is a responsibility that can be assumed by a Medical Safety Officer or physician in Consumer Medical Safety, for leading an OCMS cross-functional team of medical safety professionals/experts. In this role, the SSTL provides the Stronghold team with strategic, operational, and consumer-centric thought leadership to support the goal of helping patients and consumers realize maximal benefit free from avoidable harm with the use of J&J Consumer Health medicines, nutritional’s, cosmetics, devices and other products.

The SSL reports to the Head of Medical Safety SSRM and works closely with the Chief Safety Officer and Decision Support Lead for their Stronghold Team, as well as coordinating with the leaders of the other SST, as a key contributor to the medical safety strategy for Consumer Health.

The SSL ensures that OCMS is an effective and valued strategic partner for benefit-risk assessments with Research & Development (R&D), Quality, Commercial and other key business functions. He/she ensures that medical safety insights are integrated into J&J Consumer Health product development strategies and oversees the investigation and resolution of any emerging safety issues.

This position serves as a critical role supporting consumer
- and patient-centered decision making within OCMS. The ability to influence key decision-makers, manage external and internal partners, provide distinctive insights through thought leadership, and develop superior talent and team members are critical factors for success in this role.

Directly manages a team of Medical Safety professionals, including, Medical Safety Officers and other Healthcare professionals, supporting Safety Surveillance and Risk Management functions
- Oversee hiring, training, performance and daily activities to ensure a high functioning team, providing appropriate safety support to their allocated region or portfolio through timely and high-quality medical safety evaluations, contributions, and risk management
- Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication
- Ensures excellence and timeliness of technical training for medical safety colleagues, relevant functional partners.

Oversee the medical safety profile and mitigation of risks for allocated products/product families, including providing strategic direction for risk management plans, benefit risk evaluations, aggregate reports, health hazard evaluations, and signal evaluations
- Oversees development of medical safety content for key regulatory and clinical documents as appropriate to ensure these key safety documents are of high medical and scientific quality. These might include: Clinical Trial Protocols, Safety Sections of Investigator’s Brochure (IB), Clinical Study Reports (CSR), Periodic Safety Update Report (PSUR), and Company Core Data Sheets (CCDS).
- Lead medical safety discussions on assigned products at key governance forums, such as Safety Management teams for assigned products
- Provide direction to (Associate) Medical Safety Officers and other medical safety colleagues on activities related to signal detection, surveillance, and evaluation.
- Provides leadership in regulatory authority interactions regarding safety and risk management for the assigned portfolio, both written and verbal
- Ensures compliance of safety activities and processes with global legislation and regulatory requirements and when appropriate, contributes to their design and implementation
- Takes responsibility for the strategy and oversees implementation of, and compliance with, post-marketing risk management commitments in collaboration with the Medical Affairs, Global Regulatory Affairs and the Qualified Person for Pharmacovigilance (QPPV), for the Consumer Sector

Safety Stronghold Lead
- Functions as a team lead for the med