Clinical Label Reviewer

AbbVie seeks a Clinical Label Reviewer to independently design, review, and approve study-specific clinical labels for global clinical trials. The Grade 12 individual-contributor role ensures compliant, accurate labeling across GMP/cGMP environments and manages global regulatory requirements, vendor coordination, and phrase-library governance.

Responsibilities

• Review study protocols and partner with Clinical Supply Project Managers to determine global label requirements and design options
• Create, design, and approve study-specific and global clinical label templates within validated systems
• Ensure label compliance with GMP/cGMP, applicable procedures, and global regulatory requirements
• Obtain, document, and maintain required approvals from Regulatory Affairs, Quality Assurance, and regional regulatory affiliates
• Maintain the global clinical label phrase library, conduct annual reviews, and manage change implementation

Requirements

• Bachelor's degree or equivalent education and relevant experience
• Experience in clinical label design, clinical supply, pharmaceutical packaging, or regulated GxP environment
• Working knowledge of GMP/cGMP and global clinical-labeling regulations including US, EU, JAPAC requirements
• Ability to interpret clinical protocols, apply regulatory requirements, and exercise independent judgment
• Strong project management, analytical, organizational, communication, and issue-escalation skills
• Preferred: 3–5+ years in clinical trial design, labeling, packaging, or pharmaceutical manufacturing
• Preferred: Experience with validated label design systems, controlled phrase libraries, and vendor coordination