Insulet Corporation, Billerica MA US 01821
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Job Description :
With the OmniPod Insulin Management System as its flagship product, Insulet Corporation is one of the fastest growing medical device companies in the U.S. as well as internationally. Insulet now innovates, manufactures and commercializes technologies for continuous subcutaneous infusion for a variety of drug therapies. In support of fast expanding international territories as well as a growing product catalogue, the Product Labeling Specialist is a central part of Insulet’s Product Marketing team.
The Product Labeling Specialist is fully accountable for all aspects of the production and change implementation for our product labeling. The successful candidate will demonstrate a meticulous orientation to detail and an unyielding care for the production of the highest quality, accurate, precise and consistent labeling product possible. Primarily this includes, but is not limited to:
Production of original content, such as user manuals, to present technical and/or medical details in easy-to-read layman terms. Collaboration with Product Managers, Engineering, Quality and Regulatory to ensure fully accurate treatment of all product details. Rigorous attention to the implementation and versioning control of product labeling changes, including management and quality assurance of translation or other outside services where applicable. Constant assurance of alignment with Regulatory and Quality on the effective labeling requirements for various lines of products and international product line extensions. Meticulousness in all labeling formatting, editing, grammar control, review and proofreading.
In this capacity, the Labeling Specialist will support new product development as well as currently marketed product configurations for the U.S. and internationally. While responsible for the production and documentation of all product labeling, the Product Labeling Specialist is also expected to participate in the continuous evaluation of the effectiveness and reliability of our labeling process in the context of our overall Quality Management System (QMS)s, as we constantly strive for new levels of process maturity.
JOB / DUTIES / RESPONSIBILITIES
• Work closely with Regulatory to understand domestic and international product labeling and packaging requirements and keep all labeling requirements documentation up to date accordingly.
• Continuously create and adjust labeling templates in accordance with changes in labeling requirements.
• Work 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.
• Create and modify labeling for product labels, packaging and other related materials ensuring that they meet all medical, legal and regulatory requirements for medical devices following the established design format and corporate branding guidelines.
• Own the creation, writing, review, redlining, editing and proofreading of all label artwork for a consistently reliable, accurate and high quality output.
• Ensure that all labeling changes are implemented in a consistent manner across all applicable product lines for both the domestic and international markets.
• Coordinate and control all label design and approval projects, including collaboration with engineering and other relevant functions to develop and obtain approval and release of label drawings.
• Ensure that the label content review and approval process is comprehensive and consistently executed across all internal and external relevant functions.
• Prepare and execute Engineering Change Orders.
• Collaborate with all relevant functions to manage the review and approval to ensure smooth internal approval and acceptance into finished goods
• Maintain comprehensive database of all product labeling on a configuration basis, inclusive of all parts, revisions and associated drawings.
• Manage 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.
• Identify, propose and track efforts to continuously improve our processes for creating and maintaining product labeling, including but not limited to, optimization of labeling procedures and development of work instructions and/or work flow diagrams.
• Provide supports to all initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Education / Experience
• BA/BS degree is required or equivalent experience
• 3+ years of experience with international and or US medical device labeling
• Demonstrated understanding of the labeling process and related issues in the Medical Device or Pharmaceutical industry required, specifically as it pertains to US FDA, EU and Canada labeling requirements
• Vendor management experience required
• Project management experience required
Skills and Competencies
• Excellent technical skills with exceptional orientation to detail
• Excellent verbal and written communication skills
• Strong project management, organization and planning skills required
• Ability to handle multiple projects and prioritize work independently
• Ability to work cross-functionally to address labeling issues, develop plans of action, and manage completion of labeling projects
• Ability to generate and maintain accurate records
• Work well in a team environment
• Strong working knowledge of Adobe CS Suite (InDesign, Illustrator, Acrobat), Bartender, or similar label design software required.
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