Clinical Labeling Project Coordinator — Pharma Operations

Planet Group; Santa Monica (CA); On-site; USD 61,000 - 87,000; Full time

Job summary

Planet Group is seeking a Clinical Labeling Operations (Project Coordinator) to coordinate labeling implementations with Regulatory Affairs, QA Labeling, and packaging sites globally. You will map label content in Bartender and ensure alignment with source documents.

Responsibilities include SOP drafting, cross-functional project timeline management, and updating labeling across sites. Requires pharma/regulatory experience and strong communication skills.

Qualifications

• 6+ years of relevant experience or 4+ years with MS.
• Prior experience in pharmaceutical or other regulated industry is required.
• Prior experience in clinical or commercial supply chain is preferred.
• Familiarity with artwork/labeling production is beneficial.
• Knowledge of FDA and cGMP standards and regulatory guidance documents.
• Proficient in Microsoft Office applications and strong writing skills.

Responsibilities

• Coordinate new clinical labeling implementations with Regulatory Affairs, QA Labeling, and packaging sites worldwide.
• Create labels content and map content to Bartender fields.
• Create Business Continuity Labels and map contents accordingly.
• Review label content and Bartender mappings against source documents.
• Liaise with Regulatory Affairs Labeling to obtain correct text and timelines.
• Lead operational excellence projects with limited precedent and guide teams.

Skills

Project coordination

Regulatory labeling

Bartender software

MS Office

FDA & cGMP knowledge

Pharma experience

Education

BS or BA in related field

MS in related field

Tools

Bartender

Job description

Planet Group is seeking a Clinical Labeling Operations (Project Coordinator) to coordinate labeling implementations with Regulatory Affairs, QA Labeling, and packaging sites globally. You will map label content in Bartender and ensure alignment with source documents.

Responsibilities include SOP drafting, cross-functional project timeline management, and updating labeling across sites. Requires pharma/regulatory experience and strong communication skills.