Clinical Labeling Operations Specialist

Our client, a world leader in biotechnology and gene therapy, is looking for an Clinical Labeling Operations Specialist.

Job Duration: Long Term Contract (Possibility Of Extension)

Pay Rate : $56.79/hr on W2

Company Benefits: Medical, Paid Sick leave, 401K

The Labeling Operations Specialist coordinates the implementation of new clinical labeling and labeling updates across Regulatory Affairs, Quality Assurance, Supply Chain, project teams, and packaging sites worldwide. This role ensures label content is accurately transferred, mapped, reviewed, and implemented in accordance with source documents, FDA requirements, cGMP standards, and applicable regulatory guidance.

Key Responsibilities

• Coordinate global clinical labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites.
  
• Create and map label content within Bartender and develop Business Continuity Labels.
  
• Review final product label content and mapping for accuracy and alignment with source documents.
  
• Partner with Regulatory Affairs to obtain approved text, manage timelines, and ensure requirements are met.
  
• Lead operational excellence and process improvement projects.
  
• Author and update SOPs, guidelines, and work instructions.
  
• Support labeling updates and collaborate cross-functionally to meet departmental objectives.
  

Required Qualifications

• Bachelor’s degree with 6+ years of relevant experience, or Master’s degree with 4+ years of relevant experience.
  
• Experience in the pharmaceutical or other regulated industry.
  
• Experience with clinical or commercial supply chain operations.
  
• Familiarity with pharmaceutical artwork and labeling production.
  
• Knowledge of FDA regulations, cGMP standards, and regulatory guidance.
  
• Strong project coordination, communication, technical writing, and interpersonal skills.
  
• Proficiency with Microsoft Office.
  

Preferred: Experience with Bartender software and label content mapping.

If interested, please send us your updated resume at

[email protected]/[email protected]