Location: Mounds View, MN
Duration: 12 months (potential contract to hire)

Position Description

This position is responsible for planning, research, and technical writing support for medical device industry product labeling within CVG Technical Communication.

Position Responsibilities

  • Seasoned technical writing professional who provides labeling support to product development teams, including:
  • Able to translate complex product information into concise, compliant, easy-to-follow instructions for use.
  • Broad understanding of the impact of language localization and its effect on English content.
  • Comprehensive project management, including development and maintenance of work breakdown structure, project schedule, and milestones.
  • Able to identify and mitigate assumptions, dependencies, and risks related to IFU development and implementation.
  • Successfully negotiate project schedules and implementation plans to support the labeling process.
  • Acquire subject knowledge by interviewing writers, product developers, regulatory, quality, and marketing personnel, and by referring to the product, technical specifications, and engineering illustrations and trade journals.
  • Manage stakeholder input and negotiate content development strategy for complex product development and sustaining engineering projects.
  • Solid understanding in how regulations, laws, standards, product specifications, and internal procedures impact IFU design.
  • Respond to new or changed user requirements by planning changes or improvements to IFU content.
  • Influence product implementation plan through labeling architecture and electronic labeling strategy.
  • Coordinate IFU translations through internal or external sources.
  • Coordinate the review and approval of technical documents for a project team in enterprise configuration management systems.
  • Maintain necessary records for project tracking and legal/regulatory requirements.
  • Work with translation partners to broaden the business’ understanding of content localization and the need for well-written global English content.

Basic Qualifications

  • BA/BS in Technical Communications or related field
  • Demonstrated expertise in technical writing
  • Proven application of project management tools
  • Experience working with cross-functional project teams
  • Working knowledge of software technologies used for writing, publishing, and document control.
  • Understanding of product labeling development in a regulated industry
  • 4+ years of experience in technical writing with a Masters’ degree
  • 6+ years of experience in technical writing with a BA/BS degree

Other Desired experience:

  • Understanding of the following topics:
  • ISO regulations, FDA design controls, Good Manufacturing Process (GMP), etc.
  • User experience principles
  • Authoring in XML in a single-source content development environment
  • Ability to work effectively across disciplines to implement creative solutions to complex problems
  • Writing for a global audience
  • Certification in any of the following disciplines:
  • PMP
  • Lean Six Sigma
  • Change Management
  • Kepner-Tregoe
  • Experience creating content for software or apps
  • Ability to manage multiple projects

 

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