Global Labeling Specialist
CooperVision
- Trumbull, CT
- Permanent
- Full-time
- 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.
- 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.