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

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Johnson & Johnson Medical Devices Companies a member of Johnson & Johnson's Family of Companies is recruiting for a Labeling Associate. This position will be located in Irvine, California.

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/ (https: //www.jnj.com/

This individual will be responsible for supporting label development including technical aspects of labeling projects, creating labeling change control documentation, and executing the end-to-end implementation of labeling changes.

Key Role Responsibilities:

• Design and develop labels and contribute to the validation process of modifying label templates, ensuring necessary criteria and specifications are met.
• Assist in conducting impact analysis and ensuring scope alignment, facilitating the creation of change control documentation. This involves implementing modifications to labels, Instructions For Use (IFUs), and carton contents, as well as reviewing and proofing both digital and printed materials to ensure accuracy and consistency.
• Assist in resolving Non-Conformities (NC) and Corrective and Preventive Actions (CAPA) activities related to labeling.
• Participate in the Lifecycle Labeling Project Portfolio Review Process. This entails a regular cadence of obtaining project requests, engaging in Lifecycle team governance, and driving cross-functional teams to evaluate the projects' business case. Further, it involves conducting risk analyses and formulating recommendations regarding approval, prioritization, and project change governance.
• Partner with Supply Chain, Quality, Regulatory, Marketing associates for prioritization and execution strategies ensuring partners understand outputs of all decisions.
• Contribute to process improvement projects and propose solutions. Identify and define gaps, improve, enhance, and correct relevant procedures.
• Prioritize and manage multiple labeling projects simultaneously to meet deadlines.
• Know & follow local Quality System policies & procedures.
• Maintain product label design and process knowledge for responsible platforms.
• Advocate on behalf of labeling team and influence outcomes for projects.

Qualifications

Education:

• Bachelor’s Degree Required

Experience and Skills:

Required:

• At least 1 year of experience related directly to medical device labelling
• PLM System Knowledge
• Experience with labeling design and development process
• Agile and effectively works well in a fast-paced environment
• Proven track record of Project Management
• Excellent written and verbal communications
• Proven ability to lead several projects simultaneously
• Ability to follow established grammatical and formatting conventions, templates, and style guides
• Strict attention to detail
• Collaborate in a cross-functional team

Preferred:

• ERP System knowledge
• Understanding of compliance requirements for medical devices and labeling
• Understanding of Manufacturing Packaging and Labeling processes
• Technical Writing skills

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 innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

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.

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 (http: //www.careers.jnj.com).

The anticipated base pay range for this position is:

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