Labeling Specialist II

Responsible for coordination of all labeling deliverables (will vary by project), including DFUs, patient guides, labels, carton and pouch artwork, label stock, 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. Assist with training/mentorship for less experience team member as needed. Identify and implement opportunities for continuous improvement and innovation. Honours Degree (level 8) in a relevant discipline 3 - 5 years' experience in a similar role Project Management Experience strongly preferred Exceptional communication, facilitation, interpersonal, and relationship-building skills. Extremely detail-oriented. Ability to clearly communicate complex information across multiple functions, create buy-in from team members, and negotiate disagreements productively. Strong knowledge of labeling processes and complexities: up-front requirements, translations, reviews, regulatory agencies and requirements, operations and distribution, working with external vendors, etc.