Remote Global Labeling Operations Specialist

Parexel; Madison (WI); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Global Labeling Specialist (Operations) for a remote-capable role. You will support labeling operations, regulatory compliance, and document management across regions, coordinating with Regulatory, Artwork, and Change Management teams.

Ideal candidates have 3+ years in pharma/biotech labeling operations, plus strong experience with regulatory tracking and EDMS systems, and a bachelor’s degree in a scientific discipline.

Qualifications

• 3 years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations
• Experience with products developed through the full drug development and registration lifecycle in an innovator company environment
• Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development
• Proven experience with document management systems, regulatory tracking systems, and change management platforms
• Strong communication, organization, and problem-solving skills
• Demonstrated understanding of the importance of labeling governance and compliance

Responsibilities

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to ensure changes to planned artwork activities and implementation timelines are communicated effectively
• Record regulatory assessments and ensure the Change Management System is appropriately linked to the Regulatory Tracking System
• Support the development and maintenance of regulatory-compliant, competitive, and high-quality labeling documents throughout the product lifecycle, including CDS, Global Patient Leaflet, Target Label Profile, EU Product Information, and USPI
• Distribute and track CDS updates, maintaining compliance within the EDMS and regulatory tracking systems
• Track implementation of labeling updates across regions and countries, supporting Regional and Local Regulatory Leads in responding to Health Authority queries
• Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems, and create, maintain, and update regulatory labeling procedures and SOPs
• Provide training to internal stakeholders and new joiners on labeling process requirements and maintain current knowledge of global labeling regulations and governance standards

Skills

Regulatory labeling operations

Document management systems

Change management

Cross-functional collaboration

Regulatory affairs knowledge

Education

Bachelor’s degree in a scientific or medically related discipline

Tools

EDMS

Regulatory tracking systems

Structured Product Labeling (SPL)

Job description

Parexel is seeking a Global Labeling Specialist (Operations) for a remote-capable role. You will support labeling operations, regulatory compliance, and document management across regions, coordinating with Regulatory, Artwork, and Change Management teams.

Ideal candidates have 3+ years in pharma/biotech labeling operations, plus strong experience with regulatory tracking and EDMS systems, and a bachelor’s degree in a scientific discipline.