Responsibilities
- Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components
- Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies
- Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies
- Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects
- Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards
- Drive process improvements related to artwork development, approval workflows, and digital tools
- Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed
- Maintain artwork issue logs and attend escalation meetings to provide updates
- Identify inefficiencies and escalate to Hub Leads when required
- Participate in content lock meetings to ensure stakeholder alignment
- Manage Veraciti system-related issues and escalate appropriately
- Suggest and implement technology solutions for artwork and labeling processes
- Create, update, and maintain training documentation for systems and processes
- Supervise Artwork Controllers to ensure task completion and provide support during peak periods
- Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices
- Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment
- Track and follow up on action items from cross-functional meetings
- Communicate project status, risks, and milestones consistently to stakeholders
- Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates
- Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives
- Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required
- Conduct design-to-press color management assessments and feasibility consultations
- Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks
- Address process and executional quality issues; support system and process improvements
- Manage ad-hoc artwork-related requests and cascade process/system communications
Requirements
- Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field
- 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries
- Strong knowledge of global regulatory requirements for product labeling and packaging
- Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment
- Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva)
- Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro)
- Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.)
- Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation
- Six Sigma Green Belt certification or equivalent experience in continuous improvement
- Excellent communication, problem-solving, and organizational skills
Nice to Have
- PMP certification or formal project management training
Work Arrangement
On-site
Additional Information
- language requirements: null
- travel: null
- hours: null
- shifts: null
- equipment: null
- clearance: null
- background checks: null
- probation: null
- relocation: null
- training: null
