Johnson & Johnson Regulatory Operations (JJRO) Head, Regulat
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Dover, DE 19904
The Johnson & Johnson Family of Companies is organized into three business segments- Consumer, Pharmaceuticals, and Medical Devices. We are the world’s most broadly based global health care business serving customers, patients and medical professionals through more than 275 companies in over 60 countries.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science
- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. The Johnson & Johnson Family of Companies is recruiting for a Johnson & Johnson Regulatory Operations (JJRO) Head, Regulatory Labeling, J&J Regulatory Operations to be based at any JNJ US location with the following locations being highly preferred Raritan NJ , New Brunswick, NJ , Titusville, NJ , Spring House, PA , Horsham, PA , Malvern, PA, West Chester, PA OR at any JNJ location in the UK and EU with the following locations being highly preferred – Beerse, Belgium, High Wycombe, UK, Leiden, Netherlands.
This position is responsible for the development, maintenance and continuous improvement of an end-to-end management process for labeling and related labeling materials that spans across all J&J businesses (i.e., Consumer, Pharmaceutical, Medical Devices). The JJRO Head Regulatory Labeling will partner with other functional leads (e.g. IT, Commercial, Regulatory, Legal, Supply Chain, Operations, Clinical/Medical Affairs/Safety, among others) to ensure collaborative connectivity with these key stakeholders and a focused approach to supporting country and regional business strategies and objectives related to labeling.
• Developing, deploying and maintaining a global framework, including meaningful metrics, of improved and efficient compliant processes and technologies to support and track the development, review, approval and implementation of product labeling across J&J businesses
• Project leadership for cross-sector labeling related initiatives including conception/ planning, business case development, socialization, staffing, launch and execution oversight
• Providing thought leadership and external engagement as it relates to labeling innovation including identifying and assessing potential impact of emerging industry trends and regulation changes and interacting with external entities, such as professional societies and subject matter experts to bring forward solutions for addressing issues / capturing opportunities
• Creates, fosters and maintains effective partnerships with internal business stakeholders including, but not limited to, Supply Chain, Regulatory Affairs, Medical Affairs, Safety, Legal, IT and Marketing, to provide a focused approach to supporting country and regional business strategies across the sectors and better leverage future regulations relevant to product labeling and associated material as well as its delivery to healthcare providers, patients, consumers and end-users of our products
• Accountable for developing, deploying and maintaining a global framework of processes and systems to support and track the development, review, approval and implementation of product labeling across J&J businesses.
• Leading cross-sector executive governance & collaboration forums to drive/ influence strategy alignment and identification and prioritization of cross-sector operational excellence initiatives for labeling.
• Develops and implements mechanisms to monitor the J&J wide labeling execution performance, both compliance and efficiency, through metrics that will lead to continuous improvement and innovation.
• In partnership with the Regulatory in the sectors & Quality, lead/ launch key, strategic cross segment labeling projects with the objective of improving labeling compliance, effectiveness and efficiency as well as meeting new upcoming regulations and industry standards. Partner in order to make timely decisions and balance short-term needs with longer term strategic impact
• Aligns J&J position on external guidelines and regulations on regulatory, safety, and legal topics related to labeling; develops and implements standards and procedures aligned to J&J position.
• Effectively partners with internal stakeholders to better leverage future regulations relevant to product labeling and associated material as well as its delivery to healthcare providers, patients, consumers and end-users of our products
• Works in close partnership with multiple quality groups within the J&J Quality Organization and the Quality leadership to assure connectivity and transparency of key quality performance indicators and consistency of standards and processes across like product types.
• Gain and incorporate deep external insights on the long-term view of labeling innovation in the healthcare and the pharmaceutical industry. Expertly manage and interact with external entities such as professional societies and subject matter experts.
• A minimum of a Bachelor’s Degree in a scientific or technical discipline is required
• An advanced degree is preferred
• A minimum of 10 years of experience in the life-sciences environment is required.
• Expert knowledge of the Labeling requirements, processes and systems is required in at least one product type (i.e. medicinals, devices, consumer products) is required
• Expert knowledge of the Labeling requirements, processes and systems in multiple product types (i.e. medicinals, devices, consumer products) is preferred
• Previous experience creating organizational effectiveness strategies designed for process excellence to create business value is strongly preferred
• Either general knowledge of overall R&D / product development processes and framework OR general knowledge of supply chain processes and framework related to labeling is required.
• Experience leading transformational change initiatives across functions and geographies is required
• Significant experience leading multi-disciplinary teams is required
• Demonstrated ability to lead others through direct and indirect reports in a highly matrixed environment to deliver outstanding results is required
• Previous experience building positive relationships and influencing senior level stakeholders is required.
• Experience leading the development & implementation of complex business models is preferred
• A demonstrable track of success instilling and leading a results oriented, deliverables based organizational culture is strongly preferred.
• The willingness and ability to travel approximately 20% internationally is required.
• The willingness and ability to be based at any JNJ location in the US with the following locations being highly preferred- Raritan NJ , New Brunswick, NJ , Titusville, NJ , Spring House, PA , Horsham, PA , Malvern, PA, West Chester, PA OR at any JNJ location in the UK and EU with the following locations being highly preferred – Beerse, Belgium, High Wycombe, UK, Leiden, Netherlands is required.
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.