Responsible for the coordination and support of artwork / labeling generation and revisions related to Pre-Commercial and Commercial Supply. Focus areas include planning and coordinating labeling tasks, project tracking, creating, or modifying labeling documents of record (Master Control), preparing presentations, acting as a liaison for Anika companies’ sites, suppliers and 3rd party service organizations.
- Create documents via Master Record application per company document control procedures.
- Work cross functionally with Regulatory Affairs, Quality Assurance, Engineering, R&D, Marketing, Commercial on label creation / changes.
- Support the Commercial Development Labeling Specialist with the vendors in coordinating the language translation activities, as required, and facilitate the review, approval, and release of all labeling components from development to commercialization.
- Work with the cross functional team for generation and/or revisions to products specifications, packaging specifications, change controls, version controls and SOPs related to commercial packaging and labeling.
No direct reports. Requires coordination and management of tasks with vendors and 3rd party service organizations.
- Educational requirements High School diploma or higher
- A minimum of 1-3 years’ experience with labeling development, generation, and/or revisions in medical device and pharm regulated environment
- Working knowledge of Good Manufacturing Practices in area of Product Packaging and Labeling
- Demonstrated understanding of quality management and documentation systems, especially as related to change control process and product specifications
- Proficient in MS Office suite
- Effective interpersonal, strong verbal and written communication skills
- High attention to detail and demonstrated ability to follow multiple projects concurrently
- Good organizational and time management skills
Desired Experience, Knowledge, and Skills:
- Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics
- Be able to update, and create artwork using Adobe Suit, (InDesign/Illustrator)
- Certified in Graphics Design
- Basic project management experience
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.