Labeling Lead

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At J&J Med Tech 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.

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.

• 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/Life Cycle 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.

• Education:
  
  Minimum of a Bachelor’s degree and/or University degree is 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
• 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.
• May require up to 10% domestic and/or international travel to other locations and sites

None

• Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

The anticipated base pay range for this position is : $ - $

Subject to the terms of their…