Labeling Project Specialist II

Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, etc. Manage and coordinate creation/revision of deliverables from project initiation through completion. Assess the scope of each project and work with team members and project management to create labeling plans and secure necessary resources. Develop deliverable schedules and establish milestones for tracking progress. Ensure on-time completion of deliverables, and communicate project status, challenges, and successes on a regular basis to project and functional management. Understand and coordinate/monitor completion of key dependencies from other functions. Monitor and, when necessary, work with functional and project management to address issues that could negatively impact schedule or quality. Lead cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule. Foster and improve content consistency across labeling. Facilitate team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer. Coordinate desktop publishing and labeling artwork generation. Coordinate implementation/release activities of labeling deliverables. Manage content changes (and mitigate their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness. Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors. Identify and implement opportunities for continuous improvement and innovation. Associate's Degree 4+ years' work experience in regulated industry Medical device experience 2+ years labeling experience Direct labeling or technical writing experience desired Adobe Suite Creative Suite experience strongly preferred MS Office and MS Project experience strongly preferred Project Management