Labeling/Tech Writer

2 weeks ago

Cincinnati, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Project Services is actively seeking a Labeling & Technical Writing Specialist for a long term engagement at one of our top clients located in Cincinnati, Ohio.


Pay rate: $40/hour + benefits

Hybrid schedule


The Labeling Technical Writing Specialist is responsible for both the technical execution and project management of package product labeling and instructions for use documents within the medical device industry. This position is responsible for supporting projects and orchestrating labeling IFU development activities that includes generating production-ready graphic artworks, completing supporting documentations, maintaining consistency of the Company s brand standards, and ensuring compliance of any graphic, labeling, and IFU content within the industry regulations, standards, and guidelines.


RESPONSIBILITIES:

  • Act as the labeling representative on strategic new product development and sustaining engineering projects. Includes all labels, instructions for use, safety booklets and inserts.
  • Responsible for the end-to-end development starting with gathering design requirements and specifications all the way through to the qualification and verification process.
  • Provide technical writing capabilities for the content development and refinement of instructional literature including IFUs, Safety Booklets, inserts, etc.
  • Review product labeling including labels, cartons, IFUs and other related materials ensuring that they meet all business, medical, legal, and regulatory requirements and standards for medical devices.
  • Leads product label changes after launch based on defined needs of the business.
  • Provides guidance and recommendations on labeling related processes and work instructions.
  • Actively participates in process improvement activities and assessments.
  • Provides guidance and recommendations for appropriate labeling materials and printing processes.
  • Able to collaborate cross departmentally with product SMEs, Regulatory, Quality, Marketing, Systems and others to assess and determine label requirements and content.
  • Able to support multiple projects and manage workload and task schedules appropriately.
  • Ensures consistency of all graphic labeling application.
  • Learns, understands and owns applicable global labeling regulations and standards.
  • Will be responsible for reviewing current documentation against regulations and standards to assess gaps and needed changes.

REQUIRED SKILLS/EXPERIENCE

  • Equivalent of 3 5 years relevant work experience in medical industry or related field.
  • Experience developing artworks, graphics and instructions for regulated industry relating packaging labels, product applied labels, reference or setup guides and product renderings or illustrations.
  • Adobe Creative Suite Illustrator, Photoshop, InDesign and MS Office DESIRED
  • Working knowledge of various printing processes FDA, MDR, ISO Labeling knowledge
  • Project management
  • Advanced proficiency with written and verbal communications
  • Label creation and printing software such as Teklynx Labelview or CODESOFT a plus.

EDUCATION Bachelor s degree BS in related field.


For immediate consideration, please apply online. This position is recruited for by a remote Kelly office and not your local Kelly branch.

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