Insulet Corporation

Labeling Documentation Associate - Temp/Contract

US-MA-Billerica | US-MA-Billerica
5 days ago
Category
Regulatory Affairs / Clinical Affairs

Position Summary

 

The Labeling Documentation Associate will play a critical and leading role in supporting Product Labeling Specialist and Labeling Promotion Specialist. This position supports maintaining, developing, and implementing packaging and labeling changes across multiple product lines and multiple International Countries.

 

This position will also be critical in supporting Marketing, Commercial, Medical Affairs, Purchasing, and Quality Assurance in the review, control, and implementation of advertising, labeling, clinical publication, and vendor control for Insulet Corporation.

Responsibilities

 

  • Participate in the preparation and execution of product labeling for both domestic and international markets. This work will include but will 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,

  • Working with 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.
  • Work with Document Control to properly control all printed and electronic media.
  • Partner with Marketing and Commercial on strategies for upcoming campaigns, shows, and seminars.
  • Provide assurance that print, electronic, and consulting suppliers are adequately controlled and provide adequate quality assurance in accordance with Insulet procedures.
  • Perform other duties as assigned.

 

 

 

 

 

 

Education and Experience

  • Minimum of 2 years in the Medical Device Industry or pharmaceutical industry labeling experience required.
  • Minimum of 2 years in the Quality function working with QSR and ISO 13485.

 

  • Healthcare/life sciences labeling experience required.
  • Must have ability to understand medical/clinical and technical aspects of product.
  • Vendor management experience required.
  • Project management experience required.

 

Skills/Competencies:

  • Exceptionally detail-oriented.
  • Very strong organizational skills.
  • Effective written and verbal communication skills.
  • Ability to communicate at all organizational levels.
  • Ability to understand and communicate product knowledge.
  • Ability to comply with SOPs, regulatory guidelines, etc.
  • Able to work independently and effectively in a fast-pace team environment.
  • Strong PC skill, word processing, spreadsheets, presentations, database, desktop publishing.
  • Ability to organize and judge priorities.
  • Ability to generate and maintain accurate records.
  • Must have strong clerical skills.

 

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