Independently designs, reviews, and approves study-specific clinical label content and templates for global clinical studies, ensuring accurate, timely, and compliant labeling that enables uninterrupted clinical supply. Applies expert judgment across 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 is a proposed Grade 12 individual-contributor role integrating hands-on clinical label design with independent clinical label review and approval accountabilities. The role has broad global scope, owns quality and timelines for assigned work, and has no direct reports.
Key Responsibilities:
- Review study protocols and related documentation to determine global clinical label requirements; 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.
- Independently 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 promptly.
- Maintain the global clinical label phrase library: approve new controlled phrases, conduct annual reviews, maintain phrase quality and consistency, and execute phrase library change management, including impact assessments and implementation planning.
- Maintain and update global and country-specific regulatory requirements in partnership 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/resupply decisions and create destruction requests for expired or impacted inventory in accordance with 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 may affect clinical supply or patient dosing continuity.