Clinical Label Reviewer

BioSpace; North Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Paid time off & holidays

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking an experienced clinical labeling expert to independently design, review, and approve study-specific label content for global studies. This Grade 12 role integrates hands-on label design with independent review and approval accountabilities, and has broad global scope with no direct reports.

The position requires collaboration with Regulatory Affairs, Quality Assurance, and regional affiliates to ensure compliant labeling across the United States, EU, JAPAC, and other countries.

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Experience in clinical label design, clinical supply, or regulated GxP environments; ability to work globally and independently.
• Knowledge of GMP/cGMP, CFR, EU Annex 13, and ICH principles.
• Strong analytical, organizational, and communication skills with ability to manage multiple studies.

Responsibilities

• Review global clinical label requirements and coordinate with Clinical Supply Project Managers.
• Create, design, review, and approve study-specific and global label templates within the system.
• Ensure label text and approvals comply with GMP/cGMP and global regulations (US, EU, JAPAC).
• Obtain and document required approvals from Regulatory Affairs, QA, and regional affiliates; resolve conflicts.
• Maintain global label phrase library; conduct annual reviews and changes.
• Update regulatory requirements in partnership with labeling leadership and regulatory stakeholders.
• Coordinate with third-party label vendors on orders, proofs, and quality expectations.
• Review label and inventory impacts; support resupply decisions and destruction requests.
• Manage multiple studies with independent judgment and on-time delivery.
• Collaborate to improve labeling processes and support team goals.

Skills

Clinical labeling

Global regulatory labeling

GxP experience

Project management

Independent judgment

Education

Bachelor’s degree

Tools

Validated label design system

Phrase library management

Vendor coordination

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, X and 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

• 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 escal 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 escal

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.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html