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Insulet Corporation Product Labeling Specialist in Acton, Massachusetts

The Labeling Specialist will play a critical and leading role in supporting Global Product Labeling Manger, in maintaining, developing, and implementing packaging and labeling changes across multiple product lines.

  • Participate in the preparation and execution of the annual marketing plan with a specific focus on product labeling for both domestic and international markets. This work will include but not be limited to:

  • Working closely with Regulatory to understand domestic and international product labeling and packaging requirements,

  • Working closely with the Marketing Product Managers, Product Development, and Project Management to understand the technical functionality of products so as to be able to translate them clearly and effectively into product labeling,

  • Managing multiple vendors, including technical writers, translation houses, packaging designers, creative designers and printers to develop product labeling, packaging, instructions for use and training materials for new products, and to revise labeling and/or packaging for existing products,

  • Ensure labeling changes are implemented in a consistent manner across different product lines for both the domestic and international markets.

  • Managing product labeling and packaging through the internal review process with Marketing, Regulatory, Engineering, and Manufacturing to ensure internal approval and smooth acceptance into finished goods.

  • Perform other duties as required.

  • Minimum of 3 years’ work experience in Product Labeling.

  • Minimum of 3 years in the Quality function working with QSR and ISO 13485.

  • Minimum of 1 year experience working with UDI/GTIN requirements

  • Healthcare/life sciences labeling experience required.

  • Diabetes experience preferred.

  • Must have ability to understand medical/clinical and technical aspects of product.

  • Medical device or pharmaceutical industry labeling experience required.

  • Vendor management experience required.

Skills/Competencies:

  • Demonstrate a solid working knowledge of FDA labeling.

  • Moderate to expert proficiency with Adobe Creative Cloud, including InDesign, Illustrator, and Photoshop

  • Ability to design on-demand product labeling in BarTender software preferred.

  • Experience developing artworks and graphics, and electronic publications, for regulated medical products

  • Experience with document management systems, such as Agile PLM and SharePoint

  • Knowledge with MS Office, including Outlook, Project, and Visio

  • Knowledge of labeling workflow from creation to obsolescence

  • Excellent writing skills.

  • Strong proofreading skills and meticulous attention to detail

  • Ability to understand and communicate product knowledge.

  • Team player capable of working with and influencing cross-functional project teams.

  • Strong communication skills.

  • Ability to multi-task, organize and judge priorities.

  • Ability to generate and maintain accurate records.

  • Ability to comply with SOPs, regulatory guidelines, etc.

  • Must have strong clerical skills.

Physical Requirements:

  • No business travel expected.

External Company Name: Insulet Corporation

External Company URL: http://www.myomnipod.com/

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