Labeling Operations Specialist

🔥 0 minutes ago

🌐 United States, Peru – Remote

🇺🇸 United States – Remote 🇵🇪 Peru – Remote

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Provide operational support for initial creation and updates to labeling documents, including CDS, USPI, SPC, and associated patient labeling documents • Generate clean and marked PDF and MS Word renditions and bookmark documents as appropriate • Facilitate document workflow 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 templates such as QRD and PLR • Update and maintain the CDS log and manage document status in the document management system • Set review and approval targets, track timelines, and follow up with Labeling Team members • Create SPLs for USPIs and partner with key SMEs • Update related labeling documents for similar product classes, dosage forms, and generics • Provide shadowing opportunities to junior Labeling Operations Managers • Ensure compliance with submission standards, policies, procedures, SOPs, and regulatory requirements • Track labeling projects through defined procedures and systems • Escalate issues to the Global Labeling Lead and appropriate stakeholders • Work as a team member under general supervision using established procedures

🎯 Requirements

• Bachelor’s degree in a science or life sciences required • 2-4 years of experience in a regulated environment • Pharmaceutical labeling experience preferred • Knowledge of global/regional regulatory guidelines and requirements • Complete fluency in English • Excellent written and verbal communication skills • Logical, analytical, and writing ability • Demonstrated project management skills and attention to detail • Ability to assess and manage project timelines • Ability to multitask, prioritize, and manage multiple projects • Ability to identify and resolve problems proactively • Decision-making skills, including issue escalation to the Global Labeling Lead and stakeholders • Ability to work under general supervision using established procedures • Ability to work in ambiguous situations as part of a Work Team • Ability to apply labeling regulatory guidance on formatting requirements • Ability to consolidate comments from multiple sources • Excellent computer skills and proficiency with Microsoft Word and similar applications • Ability to prepare submission-ready documents • Available for regional or global travel 5-10% of the time, including overnight stays as necessary

🏖️ Benefits

• Remote work option • Available for regional or global travel 5-10% of the time, including overnight stays as necessary consistent with project needs and office location • Global Talent Network opportunity • EEO and accommodations support