Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. 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. We have more than 250 companies located in 60 countries around the world. Our Family of Companies is organized into several business segments (Medical Devices, Pharmaceuticals and Consumer Healthcare) which are comprised of franchises and therapeutic categories.
Having made significant contributions to surgery for more than a century, the Johnson & Johnson Medical Devices Companies are in the business of reaching more patients and restoring more lives. The group represents the most comprehensive surgical technology and specialty solutions business in the world, offering an unparalleled breadth of products, services, programs and research and development capabilities directed at advancing patient care while delivering clinical and economic value to health care systems worldwide.
Ethicon, Inc. is a surgical care company within the Medical Devices sector and we are recruiting for a New Product Development Labelling Lead to be based in Somerville, NJ.
The New Product Development Labelling Lead will:
- Be point person for New Product Development Teams in developing labeling strategies, project plans and executing project plans in support of label development for new product launches. Engaged with teams directly and represents labeling function.
- Maintain product label design and process knowledge for those platforms responsible.
- Accountable for executing Design Control documentation and execution for label Development.
- Responsible for leading collaboration for collecting requirements, alignment on label strategy and label content with Regulatory, Clinical, Quality, R&D and Product Management (PM) as required.
- Complete technical writing to translate requirements into Instructions for Use (IFU) and labeling content.
- Accountable for working with Labeling execution planning to align label development project plans with the NPD team schedules, escalating and resolving capacity constraints through prioritization, augmenting capacity or relieving project timing as aligned with NPD team and business units.
- Accountable for managing multiple project schedules.
- Accountable for managing project label development budgets and providing cost assessments as required.
- Review and approve documents representing Labeling as outlined per local quality system procedures as appropriate.
- Lead and/or support Corrective Action, Preventative Action’s (CAPAs) as required.
- Know & follow local Quality System policies & procedures.
- 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. Complete required periodic re-training in areas such as safety and environmental.
- Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area
- Ensure multi-project coordination of changes for assigned business units.
- Other responsibilities may be assigned & not all responsibilities listed may be assigned.
- A Bachelor’s Degree or Equivalent plus a minimum of six years’ experience in Operations, NPD, Technical Writing, Quality, Compliance, Regulatory and/or Manufacturing with project accountabilities is required.
- Demonstrated successful completion of leading or coordinating several projects and/or business challenges is required.
- Demonstrated ability to collaborate across cross-functional stakeholders and work within a team environment is required.
- Demonstrated understanding of the Medical Device or equivalent regulated industry, Quality Systems, labeling requirements and Change Control procedures would be preferred
- Understanding Manufacturing Packaging and Labeling processes is preferred.
- Proficiency with MS Office and/or Microsoft Projects is required.
- Experience in a New Product Development project or Lifecycle Project is preferred.
- Project Management Professional Certification, APICS certification, and/or Green Belt certification are preferred.
- This position is based in Somerville, NJ and requires up to 10% travel.
United States-New Jersey-SomervilleOrganization
Ethicon Inc. (6045)Job Function
Process EngineeringRequisition ID