Contract: Packaging Development Coordinator / USA
|Location:||Waukegan, Illinois, USA|
|Salary:||GBP184 - GBP200 per day|
Leadership for labeling project management, strategic and tactical label change planning and forecasting to ensure the Global Label Management organization meets its performance objectives. The position will lead packaging and artwork strategy and shared label strategy across the product lifecycle.
Responsibility to lead cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain to achieve the Perfect Label.
Ensures assurance of supply and compliance to content for new product launches, safety updates and other core labeling programs.
- Global product leadership for strategic and tactical planning for label change projects
- Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System.
- Project Management responsibility within the system for Production, Design and Asset workflows
- Lead label change projects and associated deliverables for launches, site transfers, country/area specific changes and other labeling focused projects.
- Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution.
- Ownership and leadership role within the Packaging and Artwork Strategy
- Lead shared label strategy development and maintenance over the product life cycle
- Change Plan ownership for labeling operations
- Act as owner for specific labeling business processes and assume role of documentation subject matter expert
- Lead role to represent GLM in early development labeling work including functioning as lead for labeling launch activity.
- Create and update artworks in accordance with Health Canada's regulations, related supporting documents and agreed timelines.
- Review/prepare all labelling filing documentation such as Notes to reviewer, Labels and Packages Certification Form for Prescription Products, in collaboration with the Regulatory filing team.
- Support/assist the Regulatory filing team in proactively responding to labelling clarification requests by providing Package Development expertise.
- Proofread artwork and ensure accuracy Right First Time (RFT) of the information by ensuring alignment with under review/approved product monograph, appropriate UPC/SCC/2D Matrix codes, label drawings, artwork specifications, die lines and other technical information as required by the packaging sites.
- Create artwork specifications and other technical information as required by the packaging site.
- Coordinate and document all required approvals of artwork.
- Prepare engineering and manufacturing/packaging documentation for rework activities of Canadian products when applicable and liaise closely with printing and rework vendors to ensure continued product supply.
- Manage updates to artwork as per regulatory, commercial, and technical requirements and determine timelines on a case-by-case basis (inventory level, production dates, Health Canada commitments/requirements, etc.).
- Support, as required, the development of graphic design and typesetting of artwork.
- Act as an Artwork Management System (AMS) Subject Matter expert and manage all Affiliate AMS activities in cooperation with Regulatory Affairs and Quality Assurance.
- Support the Launch Excellence process through evaluation of project feasibility and strategic input on timelines, priority planning, inventory write-offs, budget assessment, alternate pre-press supplier evaluation and timing impact.
- Provide support and guidance to internal stakeholders in providing Package Development expertise in various areas such as Change Management process, technical comparisons, review of advertising/promotional materials as required, launch excellence, GS1-related activities.
- Bachelor's Degree in Science, Engineering, Business or Supply Chain and minimum of 5 years' experience in Operations, Regulatory or Quality environment
- Experience working effectively across different cultures, multiple functional areas and in complex matrix environments
- Excellent written and oral communication skills with all levels of management and personnel.
- Demonstrated success in negotiating and problem solving skills
- Strong interpersonal and organizational skills
- Excellent leadership skills and a proven ability to drive cross functional collaboration.
- Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance
- Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System