Labeling Operations Specialist

Fortrea

. Provide operational support for creation and updates of labeling documents, including CDS, USPI, SPC, and associated patient labeling documents .

Posted 11/4/2026full-timeRemote • ColombiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing labeling projects and document workflows in a regulated environment, ensuring compliance with global regulatory guidelines and submission standards. Proficient in generating and editing labeling documents while maintaining high attention to detail and effective communication with stakeholders.

Highest-signal resume keywords

Pharmaceutical Labeling ExperienceProject Management SkillsRegulatory Guidelines KnowledgeDocument Management System ProficiencyExcellent Written And Verbal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labeling Document CreationQuality Control FinalizationData Quality ChecksText Verification ToolsDocument FormattingSPL CreationComparison Table PreparationLabeling Version ConsolidationRegulatory Submission StandardsAttention To Detail

Soft Skills

Analytical AbilityProblem-Solving SkillsMulti-TaskingStakeholder LiaisonDecision-Making

Tools & Technologies

Microsoft WordLabeling Tracking SystemsCorporate Document RepositoryDocument Management System

Industry Keywords

Regulated EnvironmentGlobal Regulatory GuidelinesLabeling Review WorkflowsSubmission-Ready DocumentsLife Sciences Degree

About the role

Key responsibilities & impact

Provide operational support for creation and updates of labeling documents, including CDS, USPI, SPC, and associated patient labeling documents
Manage medium to highly complex labeling projects and labeling review and approval workflows
Generate clean and marked PDF and MS Word renditions and bookmark documents
Facilitate document workflows through the corporate document repository
Finalize documents after quality control
Use labeling tracking systems and perform system data quality checks
Use text verification and proofreading tools
Notify internal stakeholders when labeling documents are available
Consolidate labeling versions and comments from reviewers and Regulatory Authorities
Prepare comparison tables for labeling team discussions
Edit and format labeling documents to comply with applicable templates such as QRD and PLR
Update and maintain the CDS log
Manage document status in the document management system
Set review and approval targets, communicate timelines, and follow up to meet deadlines
Create SPL for USPIs and partner with key SMEs
Update related labeling documents for similar product classes, dosage forms, and generics
Provide shadowing opportunities to junior LOMs
Ensure compliance with submission standards, policies, procedures, and SOPs
Track labeling projects through defined procedures and optimize system use

Requirements

What you’ll need

Bachelor’s degree in a science or life sciences required
2-4 years experience in a regulated environment
Pharmaceutical labeling experience preferred
Knowledge of global/regional regulatory guidelines and requirements
Complete fluency in English Language
Excellent written and verbal communication skills
Proven logical, analytical, and writing ability
Demonstrated project management skills and attention to detail
Ability to assess and manage project timelines
Ability to multi-task, prioritize, and manage multiple projects
Ability to identify and resolve problems proactively
Ability to make decisions and escalate issues appropriately
Ability to work under general supervision using established procedures
Ability to liaise with stakeholders effectively
Ability to work in ambiguous situations as part of a Work Team
Ability to apply labeling regulatory guidance on formatting requirements
High attention to detail
Ability to consolidate comments from multiple sources
Excellent computer skills and proficiency with Microsoft Word and similar applications
Ability to prepare submission-ready documents

Benefits

Comp & perks

Regional or global travel 5-10% of the time, including overnight stays as necessary
Remote work option
EEO and accommodations support