Clinical Labeling Operations Specialist (100% Remote)

Our client, a world
leader in biotechnology and gene therapy, is looking for an Clinical
Labeling Operations Specialist (100% Remote).

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]