Clinical Label Reviewer

AbbVie•North Chicago, IL

About The Position

The Clinical Label Reviewer independently designs, reviews, and approves study-specific clinical label content and templates for global clinical studies. The role ensures accurate, timely, and compliant labeling to support uninterrupted clinical supply, applying expert judgment in label design, phrase-library governance, country requirements, vendor coordination, and change management within a validated label design system and a cGMP/GMP quality environment. This proposed Grade 12 individual-contributor role combines hands-on clinical label design with independent review and approval responsibilities. It has broad global scope, owns quality and timelines for assigned work, and has no direct reports.

Requirements

Bachelor’s degree or an equivalent combination of education and relevant experience.
Demonstrated experience in clinical label design, clinical supply, pharmaceutical packaging, or a comparable regulated GxP environment.
Experience independently managing complex, global work.
Working knowledge of GMP/cGMP and global clinical-labeling requirements, including US, EU, JAPAC, and other country-specific regulations; familiarity with CFR, EU Annex 13, and ICH principles.
Ability to interpret clinical protocols, apply regulatory requirements, produce accurate documentation, and exercise sound independent judgment in review and approval decisions.
Strong quality, analytical, organizational, project-management, communication, and issue-escalation skills, with the ability to manage simultaneous studies and timeline commitments.

Nice To Haves

3–5+ years of clinical trial design, clinical labeling, packaging, or pharmaceutical manufacturing experience.
Experience with validated label design systems, controlled phrase libraries, booklet labels, vendor proof review, inventory/resupply processes, and change management.
Experience collaborating with Clinical Supply, Quality, Regulatory Affairs, Packaging, and third-party manufacturing or labeling vendors.

Responsibilities

Review study protocols and related documentation to determine global clinical label requirements, and partner with Clinical Supply Project Managers to evaluate label design options, supply needs, and implementation timelines.
Create, design, critically review, and approve study-specific and global clinical label templates, including single-panel and booklet labels, within the validated label design system.
Ensure label text, templates, and approvals comply with GMP/cGMP, applicable procedures, and global regulations for the United States, European Union, JAPAC, and other participating study countries.
Obtain, document, and maintain required approvals from Regulatory Affairs, Quality Assurance, regional regulatory affiliates, and other designated stakeholders; resolve or escalate approval conflicts and compliance risks.
Maintain the global clinical label phrase library, including approving new controlled phrases, conducting annual reviews, maintaining phrase quality and consistency, and executing change management, impact assessments, and implementation planning.
Maintain and update global and country-specific regulatory requirements with labeling leadership and regulatory stakeholders; assess requirements for new studies and booklet-label resupply.
Coordinate with third-party label vendors on booklet label orders, proof specifications, print readiness, and quality expectations; support label printing, reading, inspection, and timely release activities as required.
Review label and inventory impacts resulting from protocol, regulatory, or phrase changes; support inventory and resupply decisions and create destruction requests for expired or impacted inventory according to procedures.
Manage multiple simultaneous studies and competing priorities with independent judgment, accurate status communication, and accountability for on-time, right-first-time delivery.
Collaborate cross-functionally to improve labeling processes, support team goals and operational initiatives, and identify, resolve, or appropriately escalate issues that could affect clinical supply or patient dosing continuity.