Senior Clinical Labeling Project Coordinator

Pacer Group; Foster City (CA); On-site; USD 110,000 - 113,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

Pacer Group in California is seeking a Clinical Labeling Operations Coordinator for a 12-month contract onsite near Foster City. The role coordinates labeling activities with Regulatory Affairs, QA, and packaging sites worldwide.

You will create label content, map fields in Bartender, develop business continuity labels, review content for accuracy, and author SOPs while collaborating to meet department goals. The position requires 6+ years in pharma labeling or 4+ with MS.

Qualifications

• BS/BA or MS required with 6+ years (or 4+ years with MS) in pharma labeling or regulated environments.
• Experience coordinating labeling projects across Regulatory Affairs, QA, Supply Chain.
• Familiarity with FDA cGMP and regulatory guidance documents.
• Experience with labeling/content creation and Bartender mapping is preferred.

Responsibilities

• Coordinate new clinical labeling implementation with Regulatory Affairs Labeling, QA Labeling, Supply Chain Labeling BPO, PM’s and packaging sites worldwide.
• Create label content and map content to fields in Bartender
• Create Business Continuity Labels and map contents to the appropriate fields
• Reviews clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields.
• Liaises with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met.
• Manages the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
• Authors standard operating procedures, guidelines and work instructions.
• Collaborates with team members to meet departmental goals and objectives.
• Completes labeling updates as assigned.

Skills

Project coordination

Microsoft Office

Cross-functional collaboration

Verbal and written communication

Regulatory knowledge (FDA cGMP)

Education

BS/BA in a life sciences or related field

MS in a related field

Tools

Bartender software

Job description

Pacer Group in California is seeking a Clinical Labeling Operations Coordinator for a 12-month contract onsite near Foster City. The role coordinates labeling activities with Regulatory Affairs, QA, and packaging sites worldwide.

You will create label content, map fields in Bartender, develop business continuity labels, review content for accuracy, and author SOPs while collaborating to meet department goals. The position requires 6+ years in pharma labeling or 4+ with MS.