Sr Labeling Project Leader
Round Lake , Illinois
December 29, 2017

  • The Sr. Labeling Project Leader leads project teams to project closure with limited direction. There is a level of independent interaction, influence, and leadership with the project team to ensure the team keeps the project on track and delivers to commitments. The Project Leader role is guided by the product lifecycle management processes. The individual in this role will be strengthening their independence and strong leadership and project management skills in order to evolve to leading larger projects.

  • Essential Duties and Responsibilities of the Sr. Labeling Project Leader:

  • Responsible for managing multiple labeling change controls

  • Identify and collaborate with multi-functional labeling Subject Matter Experts (SMEs), such as Regulatory, Product Design Owner (PDO), Manufacturing, Quality, Packaging, and Material Suppliers, to develop the requirements and content for labeling specifications

  • Utilize compiled inputs to create a draft or consolidated redline(s) that reflect all changes to labeling content or the labeling specifications

  • Create consolidated redline for the labeling components based on requirements from Regulatory

  • Drive for approval from SME to Finalize labeling redlines/obtain a draft of labeling based upon the labeling requirements specification, labeling content, and labeling specification

  • Drive labeling changes and manage them through the change control process from initiation through implementation (change ownership and communication)

  • Responsible to perform accurate product data entries and linkages in TcU PDLM system, change data entries in the TrackWise 8 change control management system; and project data entries in labeling project SharePoint site, and review the data input of others for accuracy and compliance to procedures (i.e., CS3 role)

  • Coordinate the review and approval of labeling specifications within project deadlines and in accordance with procedural and process requirements; and coordinate language translations activities, as needed

  • Coordinate Bill of Materials creation/changes and obsolescence of superseded labeling per change plan

  • The incumbent will perform other duties as assigned

  • Qualifications:

  • Outstanding understanding and knowledge of the change control process

  • Knowledge of the labeling printing and understanding of manufacturing process preferred

  • Good interpersonal, Communication, Influencing, and Negotiation skills

  • Is very well organized, analytical and comfortable with data analysis and numbers

  • Capable in performing administrative tasks with proficient use of Microsoft Office (Word, PowerPoint, Excel)

  • Team spirit minded, can collaborate well in a team and can work autonomous on identified and specific tasks

  • Customer minded; strong communication skills: with ability to interact effectively with all levels of local and international organization

  • Experience leading cross-functional and cross-divisional teams

  • In-depth knowledge of product/document configuration management

  • Working knowledge of related business systems

  • Detail oriented individual

    Education and Experience :

  • Bachelor's degree or equivalent experience with management/documentation systems, or equivalent change control system

  • At least 3 years of experience performing product or labeling change control responsibilities, with use of TrackWise 8 system or equivalent in pharmaceutical and/or medical device environment (QA, RA, R&D, Mfg, Supply Chain), including 3 year of project management.

  • A little about us:
    Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.

    Know someone who would be interested in this job? Share it with your network.