Clinical Labeling Operations Specialist (100% Remote)

Dawar Consulting•San Mateo, CA

22d•Remote

About The Position

Our client, a world leader in biotechnology and gene therapy, is looking for an Clinical Labeling Operations Specialist. This is a long-term contract position with the possibility of extension. 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.

Requirements

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.

Nice To Haves

Experience with Bartender software and label content mapping.

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.