Global Labeling Operations Specialist - 1+ Year Contract

Medasource; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Medasource is seeking a Global Labeling Specialist (Operations) to drive labeling strategy and ensure high-quality, compliant labeling documents for patients and healthcare providers globally.

You will coordinate artwork changes, manage SPL, and support USPI and EU labeling documents throughout the product lifecycle, while coordinating with Regulatory, Artwork, and Change Management teams across regions.

Qualifications

• 3+ years pharmaceutical or biotechnology industry experience in regulatory labeling operations.
• Experience with products through full drug development and registration lifecycle in an innovator company.
• Knowledge of regulations, pharmacology, medicine, pharmacovigilance and drug development.

Responsibilities

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to coordinate changes and timelines.
• Manage Structured Product Labeling (SPL) and contribute to core labeling documents (CDS, USPI, EU Product Information).
• Track CDS updates and maintain compliance within regulatory tracking systems and EDMS.
• Provide training on labeling process requirements to stakeholders and new joiners.

Skills

Pharma/biotech experience

Regulatory labeling operations

Document management

Change management systems

Regulatory tracking

Education

Scientific/medical degree

Tools

EDMS

Job description

Medasource is seeking a Global Labeling Specialist (Operations) to drive labeling strategy and ensure high-quality, compliant labeling documents for patients and healthcare providers globally.

You will coordinate artwork changes, manage SPL, and support USPI and EU labeling documents throughout the product lifecycle, while coordinating with Regulatory, Artwork, and Change Management teams across regions.