Remote Clinical Labeling Operations Specialist

Dawar Consulting, Inc.; United States; Remote; USD 115,000 - 126,000; Full time

Job summary

Our client, a worldleader in biotechnology and gene therapy, seeks a Clinical Labeling Operations Specialist for a 100% remote, long-term contract role in the United States.

You will coordinate global labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites; create and map label content within Bartender; review final product label mappings for accuracy; partner with Regulatory Affairs to obtain approved text and manage timelines; lead operational

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.

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.

Skills

Project coordination

Communication

Technical writing

Interpersonal skills

Microsoft Office

Education

Bachelor’s degree

Master’s degree

Tools

Bartender software

Job description

Our client, a worldleader in biotechnology and gene therapy, seeks a Clinical Labeling Operations Specialist for a 100% remote, long-term contract role in the United States.

You will coordinate global labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites; create and map label content within Bartender; review final product label mappings for accuracy; partner with Regulatory Affairs to obtain approved text and manage timelines; lead operational