Labeling & Packaging Artwork Sr. Associate

Upsher-Smith; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Upsher-Smith is seeking a Senior Associate for Labeling & Packaging Artwork to lead lifecycle management of pharmaceutical labeling and packaging artwork. You will coordinate across Regulatory Affairs, QA, Manufacturing, Supply Chain, and vendors to ensure compliant, accurate, and production-ready materials.

This role requires 3 onsite days and a strong background in graphic design, packaging operations, and regulatory labeling practices.

Qualifications

• Bachelor’s degree in a relevant field.
• 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.
• Knowledge of pharma labeling requirements and regulated documentation practices.
• Portfolio demonstrating packaging, labeling, or regulated-industry artwork experience.

Responsibilities

• Lead artwork development, revisions, approvals, implementation, and archival activities across the product lifecycle.
• Create and revise labels, cartons, package inserts, IFUs, and secondary packaging components.
• Translate approved regulatory content into production‑ready artwork.
• Coordinate labeling changes from NDA/ANDA and regulatory actions.
• Place barcodes and variable data on packaging artwork.
• Review artwork for accuracy, typography, readability, color, and compliance.
• Ensure cGMP compliance and controlled document practices.
• Manage artwork workflows, version control, and change control.
• Collaborate with Regulatory Affairs on labeling reviews and commitments.

Skills

Artwork management

Regulatory labeling

Graphic design

Typography & layout

Prepress & production

Proofreading

Project management

Cross-functional leadership

Education

Bachelor’s degree in Graphic Design, Visual Communications, Packaging, Regulatory Affairs, Life Sciences, or related discipline

Tools

Adobe Illustrator

InDesign

Photoshop

Acrobat Pro

Veeva Vault

Esko WebCenter

Loftware

SAP

Job description

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.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

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.

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
• Typography and visual hierarchy
• 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
• Ability to influence in a matrix environment