Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Craft the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our dedication to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
The selected individual will be accountable for lifecycle labeling project portfolio management. Provides leadership for lifecycle label change requests and accountable for end to end execution of labeling changes . Support labeling changes that drive business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.
Key Responsibilities Include but are not limited to the following:
Leader for business unit in developing labeling strategies, development and execution of project plans Engage with business units directly and represents labeling function.
Lead the Lifecycle Labeling Project Portfolio Review Process which includes a cadence of obtaining project requests, participating in Business Unit Lifecycle team governance, and leading cross-functional team to review the projects’ business case, conduct risk analysis and develop recommendations for approval, priority and project change governance.
Partner with Business Unit PM Director or PM Lifecycle Product Manager, Quality, Regulatory, Marketing associates for prioritization and execution strategies.
Represent Lifecycle Labeling Portfolio recommendations to appropriate governance bodies for approval of recommendations. Ensure partners understand outputs of all decisions and supervise project status.
Maintain product label design and process knowledge for those platforms responsible.
Represent Labeling in Change Review Board (CRB) or equivalent within local design change control process.
Responsible for leading collaboration for impact analysis, alignment on scope and changing label content with Regulatory, Clinical, Quality, R&D and Product Management as required.
Responsible for supervising internal and/or contracted associates to complete Design Change documentation and execution in support of label design changes.
Accountable for working with Planning for phase in/phase out of changes considering commercial, quality or regulatory strategies and insuring implementation.
Review and approve documents representing Labeling as outlined per local quality system procedures as appropriate.
Lead projects as appropriate for unplanned event responses or planned changes.
Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures.
Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area