Global Clinical Label Designer & Reviewer

AbbVie Inc.; North Chicago (IL); Sur place; USD 120 000 - 160 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k)

Paid time off

Résumé du poste

AbbVie Inc. in North Chicago, IL, seeks an experienced professional to independently design, review, and approve study-specific and global clinical label content for international trials within a validated label design system and GMP quality environment.

The role has broad global scope, owning quality and timelines, and requires collaboration with Regulatory Affairs, Quality Assurance, and regional regulatory affiliates to ensure compliant labeling across countries.

Qualifications

• Bachelor's degree or equivalent combination of education and relevant experience.
• Experience in clinical label design, clinical supply, pharmaceutical packaging, or a regulated GxP environment.
• Knowledge of GMP/cGMP and global clinical-labeling requirements (US/EU/JAPAC) and CFR/EU Annex 13.

Responsabilités

• Review protocols to determine global clinical label requirements and evaluate design options.
• Create, design, review, and approve study-specific and global label templates.
• Ensure label text and approvals comply with GMP/cGMP and global regulations.
• Obtain and maintain required approvals from Regulatory Affairs and Quality Assurance.
• Maintain the global clinical label phrase library and manage change control.

Connaissances

Clinical labeling

Independent judgment

Regulatory knowledge

Quality assurance

Formation

Bachelor's degree or equivalent

Description du poste

AbbVie Inc. in North Chicago, IL, seeks an experienced professional to independently design, review, and approve study-specific and global clinical label content for international trials within a validated label design system and GMP quality environment.

The role has broad global scope, owning quality and timelines, and requires collaboration with Regulatory Affairs, Quality Assurance, and regional regulatory affiliates to ensure compliant labeling across countries.