Proofreader – Global Labeling

Under general supervision, the Proofreader – Global Labeling ensures the 100% accuracy, consistency, and regulatory compliance of global labeling and packaging graphics for critical medical devices. Product labeling scopes include product art, primary/secondary labels, folding cartons, Instructions for Use (IFUs), and multi-language insert components packaged with products. This role reads, analyzes, and compares typescript (original copy) against formatted graphic proofs to detect and mark grammatical, typographical, compositional, or localization errors. The Labeling Proofreader ensures all deliverables align strictly with brand guidelines, global regulatory standards, and corporate compliance mandates, providing clear, actionable feedback to Graphic Designers for necessary artwork corrections.

• →Artwork & Document Verification: Verifies complete documentation packages for artwork releases, ensuring all supporting design inputs, source files, and translation databases are aligned.
• →Regulatory Compliance & GDP: Strictly adheres to Good Documentation Practices (GDP) and maintains robust, audit-ready documentation records within the Quality Management System (QMS).
• →Cross-Functional Collaboration: Confers with document originators, labeling engineers, regulatory affairs, and engineering liaison personnel to resolve packaging discrepancies and compile required changes.
• →Quality Proofreading: Proofreads computer-generated product labeling, regulatory symbols (ISO 15223), global variable data, barcodes, and clinical/investigational labels to ensure zero defects.
• →Regulatory Alignment Support: Supports the continuous update of global labeling components to comply with changing international regulations (such as FDA 21 CFR Part 820 and EU MDR).
• →Project Timeline & Quality Review: Leads the proofreading phase within established project timelines to guarantee zero discrepancies between master source documents and final formatted design proofs.
• →Change Control Management: Supports labeling change execution by authoring, submitting, and routing formal change packages, including Document Change Requests (DCR) and Change Requests (CR) through PLM/document control systems.
• →Operational Agility: Performs other labeling compliance and quality assurance duties as assigned to support global supply chain readiness.

• Education: Bachelor’s degree in English, Technical Writing, Journalism, Life Sciences, or a related technical discipline preferred
• Experience: 2+  years of professional-level proofreading, preferably within a medical device, pharmaceutical, biotech, or highly regulated packaging environment preferred
• Agency Context: Experience working within an in-house corporate labeling department or a regulated packaging production agency is highly preferred.
• Technical Proficiency: Strong hands-on experience with Adobe Acrobat (markup tools), Microsoft Office Suite, and professional PDF comparison software.
• Specialized Tools: Familiarity with automated text and pixel-verification proofreading software is highly desirable.
• System Knowledge: Understanding of Document Control systems and PLM software (e.g., Windchill, Agile, or SAP) is a plus.
• Exemplary visual acuity and cognitive stamina for managing repetitive, high-detail comparative analysis.
• Superb organizational skills with a proven track record of managing multiple overlapping project deadlines.
• Ability to communicate technical, objective markup feedback constructively to graphic design partners.