Labeling Coordinator

Job Description

Job Description

Type : Contract, W2 only

Duration : 12+ months

Location : Branchburg, NJ

Pay : up to $28.75/hr

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

A leading Global Biotech Company is 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.

Responsibilities:

• 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).

Qualifications:

• 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).

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.