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Project Manager, Labeling Lifecycle Management
Company: Johnson & Johnson
Location: Cincinnati, OH
Employment Type: Full Time
Date Posted: 07/31/2021
Expire Date: 09/29/2021
Job Categories: Finance/Economics, Healthcare, Practitioner and Technician, Manufacturing and Production, Sales, Executive Management, Research & Development, Medical, Environmental, Writing/Authoring, Energy / Utilities
Job Description
Project Manager, Labeling Lifecycle Management

Ethicon Surgical Care, part of the Johnson & Johnson family of companies, is recruiting for a Project Manager, Labeling Lifecycle Management to be located in Cincinnati, OH.

 

The Ethicon Surgical Care business is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Biosurgery, Ethicon Energy, Ethicon Endomechanics, Ethicon Robotics, Megadyne, NeuWave, and Torax. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.

 

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati.

 

Accountable for lifecycle labeling project portfolio management.  Responsible for lifecycle label change requests and accountable for end-to-end execution of labeling changes in support of artwork and label component content changes. Support the labeling changes that drive business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.

 

Responsibilities

    • The project manager will partner with business units in developing labeling strategies, project plans and executing project plans. Engages with business units directly and represents labeling function.
    • Supports 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.
    • Represent Lifecycle Labeling Portfolio recommendations to appropriate governance bodies for approval of recommendations.  Ensure stakeholders understand outputs of all decisions and track 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.
    • Accountable for executing Design Change documentation and execution for label changes.
    • 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 Label Design Change documentation and execution through the label change process.
    • 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.  Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with unplanned events that impact continuity of quality supply.
    • Lead and/or support CAPAs as required. 
    • Adhere to 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

Qualifications
    • Bachelor’s Degree Required. A Masters or other Advanced degree is preferred.
    • Minimum of 7 years experience in Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or equivalent with project management and demonstrated leadership accountabilities is required
    • Demonstrated successful completion of developing and leading several processes, technical and/or business challenges is required
    • Demonstrated ability to lead a cross-functional team. Cross company, cross-region team preferred.
    • Demonstrated understanding of the Medical Device or equivalent regulated industry, Quality Systems, and Change Control procedures would be preferred.
    • Experience in a New Product Development project or Lifecycle Project is preferred.
    • Demonstrated leadership of several complex projects delivering results required
    • Demonstrated leadership of change management initiative required
    • Demonstrated ability to identify risks and create mitigation solutions required
    • Demonstrated initiation of new ideas and continuous improvement required
    • Project Management Professional Certification preferred
    • APICS Supply Chain certification preferred
    • Green Belt certification preferred
    • Demonstrated track record of Project Management required
    • Conflict Management experience is required
    • Technical Writing skills and experience preferred.
    • Demonstrated track record of Leadership results is preferred
    • Demonstrated Change and Stakeholder Management is required
    • Demonstrated understanding of compliance requirements for medical devices and labeling preferred
    • Business and financial acumen preferred
    • Customer-focused with a good understanding of our customer and commercial stakeholder needs required
    • Demonstrated understanding of an end to end Supply Chain, medical device knowledge is preferred
    • Process Six Sigma preferred
    • Design and Change Control preferred
    • PLM System knowledge such as Adaptiv, Windchill or EpiCenter and preferred
    • Understanding of Manufacturing Packaging and Labeling processes preferred
    • Ability to Influence Management in a matrix environment required
    • Labeling Design and development process knowledge preferred
    • Demonstrated leadership of projects with cross-functional teams preferred
    • Proficiency with Microsoft Projects is required
    • Ability to quickly learn and become proficient in labeling, PLM, Resource planning tools required
    • This position will be located in Cincinnati, OH, and may require up to 10% international & domestic travel

 

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.

 


Primary Location
United States-Ohio-Cincinnati-4545 Creek Road
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
General Administration
Requisition ID
2105947037W
Contact Information
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