Manager, Product Labeling Development

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and we strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn. Johnson & Johnson Vision is recruiting for a Product Labeling Execution Manager, located in Irvine, CA. The Manager, Product Labeling Execution is responsible for leading a team in the creation of product labeling in support of new product development and life cycle management projects. This Includes artwork development based on inputs from content owners and the review and approval process for medical device labeling (including IFUs, Operator Manuals, and product identification labels). Collaborates with key stakeholders in Marketing, Regulatory, Clinical, Quality Assurance, R&D and Global Operations to help define project requirements, product labeling specifications and verify content. The Manager, Product Labeling Execution leads Project Leaders, Production Artists, Graphic Designers, Labeling Process Leads, and Labeling Specialists to deliver labeling projects at the desired quality vital to satisfy regulatory compliance requirements, manage process efficiency, and meet project timeline objectives. Main areas of responsibility Ensures timely and satisfactory completion of projects and initiatives. Participates in the review of emerging and changing labeling regulations; ensures consistent implementation via procedure changes, as needed. Develop labeling standards and templates to meet regulatory requirements while supporting timely implementation to support business and customer needs. Accountable for Labeling Design process and metric tracking. Provide ownership to CAPAs (Corrective And Preventive Action), Audit Findings and Non-conformances as assigned. Lead the label content translation and verification process. Drive artwork approval to ensure accuracy, consistency and compliance with internal policies and procedures and external Regulatory requirements and guidelines. Monitor potential risk scenarios and support resolution activities to mitigate project timeline risk. Build tracking tools and dashboards to monitor all product labeling deliverables across multiple manufacturing facilities and projects. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Qualifications Bachelor’s degree preferably in a scientific or related business discipline is required. An advanced degree is desired. 8+ years of proven experience required (including 5+ years of medical devices experience). Experience with relevant labeling related regulatory requirements is required. An understanding of the end-to-end global labeling processes is preferred. Strong verbal and written communication, negotiation and partnering skills. Experience with process excellence, process improvement methodologies, including change management practices is preferred. Experience managing external service providers preferred. Experience leading a team within a matrix environment to achieve shared goals in a time sensitive environment. Knowledge of core Microsoft Office software including Word, PowerPoint, Excel and Project Knowledge of graphic design processes and software including InDesign, Photoshop, and Illustrator a plus. Knowledge of product labeling creation, maintenance and print solutions such as EasyLabel, Bartender, Loftware and PrisymID a plus. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 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. Primary Location United States-California-Irvine- Organization Johnson & Johnson Surgical Vision, Inc (6234) Job Function Engineering Requisition ID 2205999369W