Location: Minnetonka, MN
Duration: 24 months Defined term (potential temp to hire)
POSITION DESCRIPTION:
Under the direction of the Regulatory Labeling Lead, the Technical Writer Sr creates and maintains compliant documentation such as instructions for use, product manuals, package labels and other pertinent labeling support items.  This position interacts with global personnel to coordinate and prioritize labeling project requests as prioritized by New Product Development and Regulatory needs.  This includes management of the in house and in country translation processes, coordination of work requests between Distributors, company teams and labeling staff. The Technical Writer Sr will create and maintain product labeling which will require working with InDesign, Quark Express, NiceLabel, and other comparable software systems.This position is responsible for coordinating the compliance, accuracy, status, formalization, throughput and communication of controlled product labeling per global requirements.
PRINCIPAL DUTIES AND RESPONSIBILITIES:  

  1. Manages labeling projects based on prioritization from company teams, planned business needs and regulatory needs.
  2. Coordinates labeling content and meets with SMEs as necessary.
  3. Coordinates and manages technical document foreign language translations
  4. Coordinates commercial printing and proofing to ensure that printed materials meet specifications.
  5. Creates, monitors, and communicates the status of Engineering Change Orders to ensure all deadlines are met.
  6. Interfaces with Project Teams members, Distributors, Country Managers communicating implemented labeling changes and proposed changes to promote awareness globally
  7. Audits the methodologies and procedures to ensure compliance to standards for documentation.
  8. Creates label set content
  9. Formalizes, writes, and proofs documentation while maintaining the integrity of the secure original files
  10. Seeks to optimize and simplify documents and processes as they are developed or modified
  11. Facilitate and lead necessary efforts to improve labeling functions, processes, SOP’s, etc.

 

QUALIFICATIONS:

Education:

  • 4 year degree in journalism, technical writing, technical communication, English or other technical field
  • OR
  • 2 year vocational tech degree

Experience: 

  • 7 to 12 years medical device manufacturing product labeling
  • Proficient in Microsoft Office Suite, InDesign, Quark Express, and NiceLabel with strong word processing and desktop publishing skills
  • Experience with Adobe Creative Suite (InDesign, Illustrator, Photoshop, etc.)
  • Database maintenance
  • Strong technical writing and editing experience
  • Experience managing multiple large-scope projects
  • Understanding of medical device labeling regulations and standards
  • Positive, professional attitude
  • Ability to work in a fast-paced environment

Skills:

  • Strong project management skills – focused, highly organized, efficient time management, meets deadlines
  • Detail oriented and thorough
  • Excellent written and verbal communication
  • Customer focused, highly collaborative globally
  • Positive professional attitude and approach to problem solving
  • High level of experience in word processing software and interfacing with multiple software programs
  • Ability to summarize complex, technical information into basic work instructions, including pictorial representations
  • Ability to work in a fast paced environment
  • Ability to interpret technical drawings and documents
  • Strong customer communication skills
  • Ability to mentor other technical writers

 

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