Remote Clinical Labeling Operations Specialist

Dawar Consulting; San Mateo (CA); Remote; USD 115,000 - 121,000; Full time

Benefits offered by this job

Medical

Paid Sickleave

401K

Job summary

Dawar Consulting seeks a Clinical Labeling Operations Specialist for a 100% remote, long-term contract in the United States. The role coordinates labeling updates across Regulatory Affairs, QA, Supply Chain and packaging sites, ensuring FDA compliance and cGMP alignment.

Key tasks include creating label content in Bartender, mapping content to source documents, and driving process improvements while coordinating timelines with Regulatory Affairs and PMs.

Qualifications

• Bachelor’s degree with 6+ years of relevant experience or Master’s with 4+ years.
• 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 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 against source documents.
• Partner with Regulatory Affairs to obtain approved text, manage timelines, 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 objectives.

Skills

Regulatory coordination

Project coordination

Technical writing

Interpersonal skills

Microsoft Office

Education

Bachelor’s degree with 6+ years

Master’s degree with 4+ years

Tools

Bartender software

Job description

Dawar Consulting seeks a Clinical Labeling Operations Specialist for a 100% remote, long-term contract in the United States. The role coordinates labeling updates across Regulatory Affairs, QA, Supply Chain and packaging sites, ensuring FDA compliance and cGMP alignment.

Key tasks include creating label content in Bartender, mapping content to source documents, and driving process improvements while coordinating timelines with Regulatory Affairs and PMs.