Remote Global Labeling Operations Specialist

Fortrea; Peru (IL); On-site; USD 70,000 - 100,000; Full time

Job summary

Fortrea is seeking a Labeling Operations Specialist (LOS) to support initial creation and updates of labeling documents, including CDS, USPI, and SPC, for products registered in the EU. The LOS will manage a large volume of labeling projects, coordinating with the Labeling Team and stakeholders to ensure timely delivery per SOPs and regulatory requirements.

The role requires a Bachelor’s degree in science or life sciences, 2–4 years in a regulated environment, and strong English communication

Qualifications

• Knowledge of global/regional regulatory guidelines is important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English language.
• Proven strength in logical, analytical and writing ability essential.

Responsibilities

• Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
• Facilitate document workflow through corporate document repository
• Finalize documents post QC
• Utilize labeling tracking systems and perform system data quality checks.
• Utilize text verification and proofreading tools
• Notify internal stakeholders of the availability of labeling documents.
• Consolidate labeling versions.
• Consolidate comments from Labeling reviewers and Regulatory Authorities.
• Prepare comparison tables for labeling team discussions.
• Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
• Update and maintain the CDS log.
• Manage the document status in document management system
• Notify and communicate with internal stakeholders
• Set clear targets for review and approval timelines for labeling documents using effective project management.
• Follow up with Labeling Team members to ensure timely review and approval deadlines are met.
• Create SPL for USPIs, partner with key SMEs and notify internal stakeholders of its availability
• Update related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
• Provides shadowing opportunity to junior LOM's
• Responsible for ensuring compliance to Company’s submission standards, policies and procedures.

Skills

Project management

English fluency

Written & verbal communication

Problem solving

Attention to detail

Regulatory knowledge

Education

Bachelor’s degree in science or life sciences

Tools

Microsoft Word

Job description

Fortrea is seeking a Labeling Operations Specialist (LOS) to support initial creation and updates of labeling documents, including CDS, USPI, and SPC, for products registered in the EU. The LOS will manage a large volume of labeling projects, coordinating with the Labeling Team and stakeholders to ensure timely delivery per SOPs and regulatory requirements.

The role requires a Bachelor’s degree in science or life sciences, 2–4 years in a regulated environment, and strong English communication