Sr. Associate Labeling & Packaging Artwork

Job Summary

The Senior Associate, Labeling & Packaging Artwork is responsible for the creation, coordination, implementation, review, and lifecycle management of pharmaceutical labeling and packaging artwork. The position serves as a key liaison among Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, Commercial teams, printers, suppliers, and contract manufacturing organizations.

The role combines regulatory labeling knowledge, artwork management expertise, packaging operations experience, and advanced graphic design capabilities to ensure labeling materials are compliant, accurate, visually effective, and production ready.

This position requires 3 days onsite

Essential Functions

• Lead artwork development, revisions, approvals, implementation, and archival activities throughout the product lifecycle.
• Create and revise labels, cartons, package inserts, Medication Guides, IFUs, patient information materials, blister foils, sachets, and secondary packaging components.
• Translate approved regulatory content, technical specifications, and packaging requirements into production-ready artwork.
• Coordinate implementation of approved labeling changes resulting from NDA, ANDA, supplements, annual reports, and other regulatory actions.
• Place and or coordinate barcodes and other variable data on packaging artwork.
• Perform detailed technical and visual reviews of artwork for accuracy, typography, readability, color, dimensions, component codes, and compliance.
• Ensure compliance with FDA labeling requirements, cGMP expectations, and controlled document practices.
• Manage artwork workflows, version control, change control, approval routing, and implementation schedules.
• Collaborate with Regulatory Affairs on carton and container labeling reviews and health authority commitments.
• Coordinate with packaging suppliers, printers, CMOs, and manufacturing sites to implement approved artwork changes.
• Support launch readiness activities and ongoing commercial labeling maintenance programs.
• Participate in investigations, CAPAs, deviations, audits, and inspections involving labeling and artwork processes.
• Maintain artwork records, approvals, metadata, and traceability within validated systems.
• Drive continuous improvement initiatives that improve artwork quality, efficiency, and compliance.

Additional information

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience, Skills

• Bachelor's degree in Graphic Design, Visual Communications, Packaging, Regulatory Affairs, Life Sciences, or related discipline.
• Five to eight years of pharmaceutical labeling, artwork management, packaging artwork, or labeling operations experience.
• Advanced proficiency in Adobe Illustrator, InDesign, Photoshop, and Acrobat Professional.
• Strong understanding of typography, layout, visual hierarchy, color management, and packaging design principles.
• Experience with prepress activities, print specifications, dielines, bleeds, proofs, and production-ready files.
• Knowledge of pharmaceutical labeling requirements and regulated documentation practices.
• Experience with Veeva Vault, Esko WebCenter, Loftware, SAP, or similar systems preferred.
• Exceptional proofreading skills and attention to detail.
• Ability to manage multiple projects and competing priorities.

Critical Skills & Technical Competencies

• Pharmaceutical labeling operations
• Artwork lifecycle management
• Packaging artwork design
• Adobe Creative Suite expertise
• Typography and visual hierarchy
• Color management
• Print production and prepress
• Barcode, GTIN, NDC and serialization awareness
• Change control management
• Vendor and printer management
• Proofreading and artwork comparison
• Project management
• Cross-functional leadership

Preferred Qualifications

• Experience supporting NDA, ANDA, or commercial drug product labeling.
• Experience with multi-market and multilingual packaging artwork.
• Knowledge of human factors and medication-error prevention principles.
• Experience supporting product launches and packaging implementation activities.
• Portfolio demonstrating packaging, labeling, or regulated-industry artwork experience required.

Core Competencies

• Quality and patient-safety mindset
• Strategic thinking and sound judgment
• Strong communication and stakeholder management
• Organization and time management
• Continuous improvement orientation
• Ability to influence in a matrix environment