Labeling Operations Specialist

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Provide operational assistance in the creation and updating of labeling documents, which includes CDS, USPI, SPC, and related patient labeling materials.

• Oversee medium to highly complex labeling projects and manage the review and approval workflows for labeling.

• Produce clean and marked versions of documents in PDF and MS Word formats, along with bookmarking these documents.

• Facilitate document workflows utilizing the corporate document repository.

• Finalize documents following quality control processes.

• Utilize labeling tracking systems and conduct data quality checks within the system.

• Employ text verification and proofreading tools effectively.

• Inform internal stakeholders when labeling documents are ready for review.

• Consolidate different labeling versions and feedback from reviewers and Regulatory Authorities.

• Create comparison tables for discussions within the labeling team.

• Edit and format labeling documents to align with applicable templates such as QRD and PLR.

• Keep the CDS log updated and well-maintained.

• Manage the status of documents within the document management system.

• Establish review and approval deadlines, communicate timelines, and ensure timely follow-ups to meet those deadlines.

• Generate SPL for USPIs and collaborate with key Subject Matter Experts (SMEs).

• Revise related labeling documents for similar product categories, dosage forms, and generics.

• Offer shadowing opportunities for junior LOMs.

• Ensure adherence to submission standards, policies, procedures, and SOPs.

• Monitor labeling projects by following defined procedures and enhance the use of the system.

⛳️ Requirements

• A Bachelor’s degree in a science or life sciences is required.

• 2-4 years of experience in a regulated setting is necessary.

• Experience in pharmaceutical labeling is preferred.

• Familiarity with global and regional regulatory guidelines and requirements.

• Complete proficiency in the English language.

• Exceptional written and verbal communication skills.

• Proven logical, analytical, and writing capabilities.

• Demonstrated skills in project management and attention to detail.

• Ability to evaluate and manage project timelines effectively.

• Capacity to multi-task, prioritize, and handle multiple projects simultaneously.

• Proactive problem identification and resolution abilities.

• Capability to make decisions and escalate issues when necessary.

• Ability to operate under general supervision while following established procedures.

• Skills to effectively liaise with stakeholders.

• Adaptability to work in ambiguous situations as part of a team.

• Competence in applying labeling regulatory guidance concerning formatting requirements.

• Strong attention to detail.

• Ability to aggregate feedback from various sources.

• Excellent computer skills with proficiency in Microsoft Word and similar applications.

• Ability to prepare documents that are submission-ready.

🏝️ Benefits

• Opportunity for regional or global travel 5-10% of the time, including overnight stays as required.

• Option for remote work.

• EEO and accommodations support.