Clinical Label Reviewer

Role: Clinical Label Content Specialist responsible for designing, reviewing, and approving study-specific and global clinical labels for AbbVie's global trials, ensuring compliance with GMP/cGMP and regulatory requirements. Objectives: maintain accurate, timely, and compliant labeling to support uninterrupted clinical supply across multiple regions. Responsibilities: develop and approve label templates, manage phrase libraries, coordinate with vendors, and obtain regulatory and quality approvals; monitor label changes due to protocol or regulatory updates; support inventory and resupply activities; collaborate cross-functionally to optimize labeling processes. Requirements: Bachelor's degree or equivalent; experience in clinical labeling, pharmaceutical packaging, or GxP environments; knowledge of GMP/cGMP, CFR, EU Annex 13, and ICH standards; strong project management and communication skills; ability to independently handle complex, global projects. Preferred: 3–5+ years in clinical trial labeling or packaging, experience with validated label systems, vendor coordination, and change management; familiar with regulated labeling processes and cross-functional collaboration. HighValue: global scope, clinical trial support, GxP compliance, regulated labeling, and cross-regional regulatory requirements. Work setup: not specified; role appears to be an individual contributor with broad responsibilities.