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New Product Development Labeling Lead
Requisition ID: 9506180419
Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a New Product Development Labeling Lead, located in Cincinnati, OH.
Ethicon 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. 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, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The New Product Development Labeling Lead will be accountable for label and IFU development for New Product Development. Point person for New Product Development teams, working with stakeholders on the team to gather requirements, provide leadership to technical writing and content alignment, to develop and lead labeling development project plan in alignment with overall NPD Project Schedule.
KEY JOB RESPONSIBILITIES:
- · 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.
- · Responsible to maintain product label design and process knowledge for assigned platforms.
- · 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 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 leading multiple project schedules.
- · Accountable for managing project label development budgets and providing cost evaluations as required.
- · Review and approve documents representing Labeling as outlined per local quality system procedures as appropriate.
- · Lead and/or support 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
REQUIREMENTS & KEY SKILLS:
- · Minimum of five years of experience in Operations, NPD, Technical Writing, Quality, Compliance, Regulatory and/or Manufacturing with project accountabilities.
- · Demonstrated successful completion of leading or coordinating several projects and/or business challenges
- · Proven ability to collaborate across cross-functional stakeholders and work within a team environment.
- · Understanding of the Medical Device or equivalent regulated industry, Quality Systems, labeling requirements and Change Control procedures would be preferred.
- · Experience in a New Product Development project or Lifecycle Project is helpful.
- · Bachelor’s Degree Required
- · Project Management Professional Certification, APICS certification, and Six Sigma Green Belt certification preferred
- · Conflict Management
- · Advanced proficiency with written and verbal communications
- · Technical Writing skills and experience preferred.
- · Demonstrated track record of Leadership results
- · Compliance requirements for medical devices and labeling preferred
- · Labeling Design and development process preferred
- · Ability to manage several projects simultaneously
- · Customer focused with a good understanding of our customer, NPD and commercial stakeholder needs
- · PLM System and ERP System knowledge, Adaptiv or EpiCenter and JDE ERP preferred
- · Experienced with Design systems, such as Adobe InDesign and Bartender preferred
- · Understands Manufacturing Packaging and Labeling processes
- · Influence Management in a matrix environment
- · People management skills preferred
- · Proficiency with MS Office and MS Project
· Travel will be minimal, may be required for atypical needs such as benchmarking, supplier visits, visits to manufacturing sites.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Endo Surgery Inc (6041)