Clinical Labeling Operations Specialist
DAWAR CONSULTING· Information Technology And Services· Jul 24, 2026 · 3mo agoPosted 95 days ago
San Mateo, California, United States
In office
Contract
Senior
$56.79/hr
6+ years exp
Before you apply
Ghost Signal:
Open since July 24, 2026 — 95 days, and still accepting applications.
Job description
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 hr@dawarconsulting.com/akansha@dawarconsulting.com
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Benefits
Benefits detected in the listing.
401k