Labeling Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com 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: Project/Program Management Group Job Sub Function: Project/Program Management Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/ Auris Health, a member of the Johnson & Johnson family of companies is currently hiring for two Labeling Lead roles, located in Cincinnati, Ohio and Santa Clara, California. We are seeking a detail-oriented and strategic Labeling Lead to be responsible for the development and management of product labels for both New Product Development (NPD) and Lifecycle Management (LM) projects. This key role leads all aspects of the end-to-end execution of labeling changes, ensuring alignment with artwork, label components, and regulatory compliance. The ideal candidate will support business objectives by driving label content updates that reflect regulatory requirements, supply chain strategies, and company standards, ultimately ensuring accurate and compliant labeling across all product lines. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At J&J MedTech we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Join our collaborative, rapidly growing teams. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes. Responsibilities: Responsible for label development for New Product Development (NPD) and Lifecycle Management (LM) projects Responsible for creating, editing, and maintaining high-quality documentation to support our products, ensuring compliance with industry standards and regulations. Responsible for communicating business related issues or opportunities to next management level Accountable for executing Design Control documentation and execution for label development. Responsible for completion of the Label Assessment, redline of IFU/artwork, IFU Creation forms and ACCLM content sheet/DCAF, translation management. Point person for New Product Development/LifeCycle teams in executing labeling strategies, project plans and executing project plans in support of label development for new product launches and lifecycle revisions. Responsible for leading collaboration for collecting requirements, alignment on label strategy and label content with Regulatory, Clinical, Quality, R&D, PM Lifecycle, as required. Accountable/responsible for working with labeling execution planning to align label development project plans with the project team schedules, escalating to resolve capacity constraints through prioritization, augmenting capacity or relieving project timing as aligned with project team and business units. Write, review, and revise technical documents including user manuals, packaging inserts, service manuals, and training materials. Qualifications: ​ Education: Minimum of a Bachelor’s degree and/or University degree is required Required: A minimum of 4 years of relevant work experience is required. (6 years is preferred) Demonstrated track record of Project Management Demonstrated ability to manage several projects simultaneously Information development using DITA XML and component content management systems (CCMS). Influence and conflict resolution Preferred: Demonstrated ability to lead a cross-functional cross region team. Demonstrated understanding of Medical Device or equivalent regulated industry, Quality Systems and Change Control procedures. Other: May require up to 10% domestic and/or international travel to other locations and sites 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving,