Location: Minnetonka, MN
Duration: 6+ months

Job Description

The Principal Technical Writer will independently lead a team to create compliant, clinically excellent labeling. This includes product labeling such as instructions for use, product manuals, package labeling and other pertinent labeling support items.  This requires supporting product development teams, supporting Product Support Team (PST) initiatives and supporting wide product labeling projects.  The Principal Technical Writer will serve as subject matter expert for global labeling requirements.

This position leads the labeling group in supporting the authoring and editing of labeling procedures and ensures that procedures are kept up to date with changing global regulations.

The Principal Technical Writer will interact with global personnel to coordinate and prioritize labeling project requests as prioritized by PST Teams and Regulatory needs.  This includes oversight of the in house and in country translation processes, coordination of work requests between Distributors, company teams and labeling staff.

This position prioritized, delegates and manages tasks for work requests that come through the technical writing group. This position is responsible for coordinating the compliance, accuracy, creation and implementation of controlled labeling documentation per Company and global regulatory requirements.

Creating labeling content based on best science known to R & D, Training, etc.

Required Qualifications:

  • 4 year degree in graphics, technical communication, journalism, English, or other technical or science-based field.
  • 10+ years desired, minimum 8 years, of recent work experience working with technical documentation in the medical device industry.
  • 2+ years leading a global labeling team and/or 2+ years as a Principal Level Technical Writer
  • Independently leading a team to ensure the creation of complaint, clinically excellent labeling.
  • Extensive knowledge of global regulations and standards for medical device labeling, serving as a Subject Matter Expert in labeling requirements.
  • Proficient with Microsoft Office Suite, with strong work processing and desktop publishing skills.
  • Proficient with Adobe Creative Suite (InDesign, Illustrator, Photoshop, Dreamweaver) and Quark Express
  • Experience with web administration and a good understanding of “HTML and CSS.
  • Extensive experience in writing, proofreading and editing documents.
  • Prefer international experience such as working with translations
  • Experience improving and creating processes to drive efficiency and excellence.