What are the responsibilities and job description for the Labeling Specialist, Biosense Webster, Inc. position at Johnson & Johnson?
Biosense Webster Inc (BWI) is recruiting for the role of Labeling Specialist, located in Irvine, CA.
At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.
Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.
Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.
This individual will be responsible for driving end to end execution of labeling changes that involve regulatory, compliance, and supply chain strategies. He/she will be accountable for strategies in support of the labeling portfolio and take the lead in designing, setting up, and coordinating labeling activities.
• Responsible for executing labeling strategies and project plans.
• Support the rollout of eIFU globally.
• Provide expert support creating and managing the lifecycle of templates, artwork, and IFUs.
• Maintain product label design and process knowledge for responsible platforms.
• Accountable for Lifecycle Labeling Project Portfolio Review Process which includes a cadence of acquiring project requests, participating in 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 Supply Chain, 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.
• Responsible for executing Design Change documentation and execution for label changes.
• Responsible for leading impact analysis, alignment on scope and changing label content with Regulatory, Marketing, Quality, R&D as the need arises.
• Lead projects as appropriate for unplanned event responses or planned changes. Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with unplanned events that impact continuity of supply.
• Provide support to resolve NC and CAPA activities
• Lead process improvement projects and propose solutions. Identify and define gaps, improve, enhance, and correct relevant procedures. Provide guidance and training as needed.
• Know & follow local Quality System policies & procedures
Qualifications
Required:
• Bachelor’s Degree
• At least 1 year experience related directly to labeling
• Proven track record of Project Management
• Excellent written and verbal communications
• Basic knowledge of labeling design and development process
• Proven ability to lead several projects simultaneously
• Ability to follow established grammatical and formatting conventions, templates, and style guides
• Strict attention to detail
Preferred:
• PLM System and ERP System knowledge
• Understanding of compliance requirements for medical devices and labeling
• Understanding of Manufacturing Packaging and Labeling processes
• Technical Writing skills
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.
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 cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.
Primary Location
United States-California-Irvine-31 Technology Dr
Organization
Biosense Webster Inc. (6010)
Job Function
Engineering
Requisition ID
2205998597W
Salary : $0
