Senior Manager New Product Development Labeling

Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a New Product Development Labeling Man ager, located in Cincinnati, OH; Somerville, NJ; Raynham, MA or Irvine, CA.

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 Manager is accountable for the New Product Development Labeling portfolio management across OneMD. Point person for New Product Development Labeling requests and accountable for the delivery of labeling artwork and instructions for use (if in scope) to the Project Team. Support the New Product Development Teams through labeling deliverables in support of Research and Development Launches as well as business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.

Job Responsibilities:

  • · Point person for OneMD Franchises for all Research and Development Product Launches and in developing and integrating labeling strategies, project plans and executing project plans with these Product Launches. Engaged with business units directly and represents labeling function for all New Product Development Projects.
  • · Lead the New Product Development Labeling Project Portfolio Review Process which includes a cadence of obtaining project requests, participating in Stage Gate discussions and assigning resources at the appropriate time.
  • · Partner with Business Unit PM Director and R&D Project Director and R&D Group Directors, Quality, Regulatory and Marketing associates for NPD Projects and execution of strategies, this role will have a dotted line to the PM Director and R&D Project and Group Directors accountable for the business units being supported.
  • · Represent New Product Development Labeling Portfolio to project teams and stakeholders. Ensure stakeholders understand outputs of all decisions and track project status.
  • · Maintain product label design and process knowledge for those platforms responsible.
  • · Responsible for supervising internal and/or contracted associates to complete all Labeling documentation and execution through the label process.
  • · Accountable for working with the Project Teams especially Product Management, Packaging, Planning and Procurement for all launch 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 Launch timelines.
  • · Develop & execute multi-generational project planning (MGPP) strategies to meet quality, compliance, delivery and cost goals in partnership with Lifecycle Labeling Managers.
  • Lead and/or support CAPAs as required.


Qualifications

Qualifications:

  • · Bachelors Degree Required
  • · Masters degree preferred. M.B.A. preferred
  • · Minimum of eight years of experience in Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or equivalent with significant project and leadership accountabilities.
  • · Successful completion of developing and leading several processes, technical and/or business challenges
  • · Ability to lead a Cross-functional team. Cross company, cross region team preferred.
  • · 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.
  • · Project Management Professional Certification preferred
  • · APICS certification preferred
  • · Black Belt Certification Preferred
  • · Green Belt certification required
  • · People management and talent development
  • · Understanding of compliance requirements for medical devices and labeling
  • · Understanding of an end to end Supply Chain knowledge
  • · Proficiency in Completing a CAPA
  • · Labeling Design and development process knowledge
  • · Resource planning
  • · Capable of assessing and developing strategies for new requirements
  • · Able to lead and deliver improvements and standardization across the COE
  • · Leadership of projects across Quality Systems, Plants, and Regions
  • · Knowledge and experience of aligning ISO and other Standards within procedures and processes
  • · Proficiency with MS Office
  • · Proficiency with Microsoft Projects, Visio
  • · Proficiency with Statistical Analysis software
  • · Able to quickly learn and become proficient in labeling, PLM, Resource planning tools
  • · People Management and Talent Development Experience required
  • · Leadership of several complex projects delivering results
  • · Leadership of change management initiative
  • · Ability to analyze and develop strategies
  • · Ability to handle complexity
  • · Ability to identify risks and create mitigation solutions
  • · Initiation of new ideas and continuous improvement


TRAVEL REQUIREMENTS:

Frequent travel up to 20%, including internationally. Some travel may be on short notice.

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.

Primary Location
United States-Massachusetts-Raynham
Other Locations
North America-United States-Ohio-Cincinnati, North America-United States-California-Irvine, North America-United States-New Jersey-Somerville
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Process Engineering
Requisition ID
9581180422


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