Global Clinical Label Designer & Reviewer

Allergan; North Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie is seeking an experienced professional to independently design, review, and approve study-specific and global clinical labels for worldwide use. You will govern templates, phrase libraries, and regulatory compliance in a validated label design system, driving on-time, right-first-time delivery.

The role requires collaboration with Regulatory Affairs, Quality, and regional affiliates, with a strong emphasis on project management and global regulatory knowledge.

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Experience in clinical label design, clinical supply, packaging, or a regulated GxP environment; ability to work independently on global tasks.
• Working knowledge of GMP/cGMP and global labeling requirements (US/EU/JAPAC); familiarity with CFR, EU Annex 13, ICH principles.

Responsibilities

• Review study protocols to determine global label requirements and coordinate with project managers on design options and timelines.
• Create, design, and approve study-specific and global label templates within the label design system.
• Ensure label content and approvals comply with GMP/cGMP and global regulations; obtain necessary regulatory approvals.
• Maintain and update the global phrase library; perform annual reviews and change management.
• Coordinate with third-party vendors for booklet label orders, proofs, and print readiness; support labeling processes and releases.
• Review inventory impacts from changes and support resupply decisions.

Skills

Clinical labeling

GMP/cGMP

Regulatory awareness

Independent judgment

Project management

Education

Bachelor’s degree

Tools

Validated label design system

Job description

AbbVie is seeking an experienced professional to independently design, review, and approve study-specific and global clinical labels for worldwide use. You will govern templates, phrase libraries, and regulatory compliance in a validated label design system, driving on-time, right-first-time delivery.

The role requires collaboration with Regulatory Affairs, Quality, and regional affiliates, with a strong emphasis on project management and global regulatory knowledge.