Clinical Label Reviewer

Allergan; North Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie is seeking an experienced professional to independently design, review, and approve study-specific and global clinical labels for worldwide use. You will govern templates, phrase libraries, and regulatory compliance in a validated label design system, driving on-time, right-first-time delivery.

The role requires collaboration with Regulatory Affairs, Quality, and regional affiliates, with a strong emphasis on project management and global regulatory knowledge.

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Experience in clinical label design, clinical supply, packaging, or a regulated GxP environment; ability to work independently on global tasks.
• Working knowledge of GMP/cGMP and global labeling requirements (US/EU/JAPAC); familiarity with CFR, EU Annex 13, ICH principles.

Responsibilities

• Review study protocols to determine global label requirements and coordinate with project managers on design options and timelines.
• Create, design, and approve study-specific and global label templates within the label design system.
• Ensure label content and approvals comply with GMP/cGMP and global regulations; obtain necessary regulatory approvals.
• Maintain and update the global phrase library; perform annual reviews and change management.
• Coordinate with third-party vendors for booklet label orders, proofs, and print readiness; support labeling processes and releases.
• Review inventory impacts from changes and support resupply decisions.

Skills

Clinical labeling

GMP/cGMP

Regulatory awareness

Independent judgment

Project management

Education

Bachelor’s degree

Tools

Validated label design system

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube.

Job Description

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 elevate 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 escalated 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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