Labeling Operations Lead — Documentation & Compliance

FTCOL Fortrea Colombia Ltda.; Bogotá; On-site; COP 60,000,000 - 90,000,000; Full time

Job summary

Fortrea Colombia Ltda. is seeking a Labeling Operations Specialist to support creation and updates of labeling documents including CDS, USPI, SPC, and patient labeling.

The role involves managing complex labeling projects, ensuring compliance with templates, and coordinating with stakeholders to meet regulatory timelines. Ideal candidates hold a science degree, have 2–4 years in a regulated environment, excellent English, and strong project management and communication skills.

Qualifications

• Bachelor’s degree in science required.
• 2–4 years experience in a regulated environment; pharmaceutical labeling experience preferred.
• Excellent written and verbal communication skills.
• Complete fluency in English.
• Strong project management and organizational skills.
• Ability to manage timelines and multi-task effectively.

Responsibilities

• Generate labeling renditions (PDF/Word) and bookmark as needed.
• Manage labeling document workflow through repository.
• Finalize documents after QC and ensure templates (QRD/PLR) are followed.
• Use labeling tracking systems and perform data quality checks.
• Notify stakeholders when labeling documents are available.
• Consolidate labeling versions and reviewer feedback.
• Prepare comparison tables for labeling discussions.
• Edit/format labeling documents per templates and update CDS log.
• Set targets for review/approval timelines and monitor progress.
• Create SPLs for USPIs with SMEs and coordinate stakeholders.

Skills

English fluency

Project management

Attention to detail

Education

Bachelor’s degree in science

Tools

Microsoft Word

Job description

Fortrea Colombia Ltda. is seeking a Labeling Operations Specialist to support creation and updates of labeling documents including CDS, USPI, SPC, and patient labeling.

The role involves managing complex labeling projects, ensuring compliance with templates, and coordinating with stakeholders to meet regulatory timelines. Ideal candidates hold a science degree, have 2–4 years in a regulated environment, excellent English, and strong project management and communication skills.