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We are seeking a precise and detail-oriented Labeling Coordinator with experience in the pharmaceutical or diagnostics industries and a strong understanding of FDA regulations. This role focuses on creating and updating labeling designs while adhering to strict Standard Operating Procedures (SOPs) and regulatory standards in a compliance-driven work environment. The ideal candidate will possess excellent attention to detail, ensuring documents are properly reviewed and quality-assured, with a proven ability to manage workflows, reviews, and approvals effectively.
Job Responsibility:
Develop, format, and revise product labels, IFUs, cartons, and related labeling components for diagnostic products
Ensure all design outputs align with corporate standards and meet all regulatory requirements for new product launches and product updates
Conduct careful reviews and quality assurance of design files, identifying and rectifying errors to ensure compliance before approval/submission
Collaborate with cross-functional teams, including regulatory, quality, and product management, to execute designs consistent with required specifications and approvals
Populate templates with accurate, detailed, and approved data to ensure proper standardization and consistency across all materials
Utilize corporate workflow systems to track progress, manage reviews, gather approvals, and maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Requirements:
Bachelor’s degree in Graphic Design, Communication Design, or relevant field
3+ years of experience in graphic design within pharmaceutical, diagnostics, or FDA-regulated industries
Comprehensive understanding of FDA labeling requirements, regulatory workflows, and compliance standards
Proficiency in design software, particularly Adobe Creative Suite (Illustrator, InDesign), and familiarity with workflow tools and project management systems
Superior attention to detail with demonstrated experience in quality assurance and compliance-focused document review
Strong organizational and time management skills, capable of managing strict deadlines
Ability to work in a highly regulated, process-oriented environment while maintaining professionalism and accuracy
Strong communication and collaboration skills
Proficiency with label creation software such as (EasyLabel, & Bartender)