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: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. Manage multiple simultaneous studies and competing priorities with independent judgment, accurate status communication, and accountability for on-time, right-first-time delivery. 10. 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. Qualifications Minimum Qualifications: - Bachelor's degree or equivalent combination of education and relevant experience. - Demonstrated experience in clinical label design, clinical supply, pharmaceutical packaging, or a comparable regulated GxP environment; experience managing complex, global work independently. - 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; ability to manage simultaneous studies and timeline commitments. Preferred Qualifications: - 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. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: - The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. - We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. - This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.