Labeling Specialist

The Product Labeling Specialist is responsible for the development, review, and management of all product labeling, including instructions for use and equipment manuals. This role ensures compliance with legal, regulatory, clinical, and corporate standards, coordinating with multiple departments such as marketing, R&D, and manufacturing. Key responsibilities include designing labeling materials, managing translation processes, proofing documents, and handling multiple projects concurrently while adhering to Good Manufacturing Practices (GMPs). The ideal candidate has experience in the medical device or pharmaceutical industries, proficiency in graphic design tools, and excellent organizational and communication skills.

Job Duties:

• Handles requests for development, reviews, and changes of all product labeling.
• Ensures all content for product labeling, Instructions for Use, and equipment manuals meet all required legal, regulatory, clinical, marketing, packaging, manufacturing (contract and internal) and R&D requirements through the use of corporate labeling guidelines and SOPs.
• Design labeling materials according to specific parameters to meet the requirements of the corporate master brand (labels, Instructions for Use artwork/layout, etc.)
• Establishes needs for translations as defined in the marketing/product specifications and manages the process for translation completions and reviews for project assigned.
• Coordinates proofing of various Labeling materials (Instructions for Use, Manuals, and Labels) using manual and electronic proofing tools.
• Coordinates reviews with all disciplines of various product labeling materials and maintains product labeling files.
• Manages multiple projects concurrently, while complying with good manufacturing practices (GMPs), regulatory, quality systems standards and labeling requirements.
• Develops Labeling component specifications.
• Provide graphics/labeling support to other departments as required.

Soft Skills:

Individual in this position has primary responsibility for the development/release of all product labeling on a timely basis. Based on the control and completion of multiple priorities, this position can have a significant impact on the release of new products and/or line extensions to the market.

• Approachable and enthusiastic
• Flexible and adaptive
• Detail oriented
• Multitasker and demonstrates problem-solving ability

Requirements:

• Degree or equivalent
• 3+ years of experience in medical device / pharma industry with relevant requirements experience developing artwork and graphics for regulated medical device or drug products and creation and management of design changes in an electronic environment.
• Experience utilizing computer-aided design equipment and/or graphic tools such as Adobe CC.
• Experience with in-house, on-demand labeling system such as Prisym, BarTender and JetMark.
• Flexibility to accommodate and manage changing priorities, deadlines, and project needs.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Customer-service orientated with demonstrated ability to build cross-functional relationships with internal and external personnel.
• Excellent organization, problem solving, and communication skills and the ability to work effectively with cross functional teams.
• Technical writing, copy editing, and verbal communication skills.
• Knowledge of the manufacturing processes and ability to work with manufacturing plants to drive labeling changes into production.