Technical Communications Specialist, R&D in Carrigtohill at Stryker Corporation

Date Posted: 9/10/2020

Job Snapshot

Job Description

KEY AREAS OF RESPONSIBILITY

  • Develop and update IFUs (write, edit, revise) and labels (format content) for new and legacy product labelling.
  • Use a variety of specialized software to develop labeling: desktop publishing, XML authoring environment, label software, translation management software, etc.
  • Develop labeling with inputs from R&D, Regulatory Affairs, Product Safety, Clinical Sciences, and other subject matter experts. Ensure accuracy of information alignment with inputs.
  • Ensure formats and symbols comply with applicable governing standards, regulations and best practices.
  • Generate and/or obtain graphical elements used in labeling.
  • Advise business units on translation strategies that satisfy international labeling needs for new product development including mergers & acquisitions. This includes localization and distribution strategy planning.
  • Participate in brainstorming/planning of new or modified labeling strategies
  • Participate in usability studies and/or voice of customer activities as needed
  • Obtain language translations from external service provider. Some negotiation may be required to address scheduling/pricing. Ensure translations are executed in an efficient and timely manner. Review translations for completeness. Inform Business Units on relevant aspects of the labeling process such as costs, and timelines.
  • Determine level of risk for “at-risk” investment of pre-approved source text and communicate impact of language translation for packaging and/or distribution and project timelines.
  • Keep project managers informed of progress/delays.
  • Support purchase orders and invoices related to translation as required
  • Understand production methods for labeling to communicate with external printing services if needed.
  • Manage labeling via the PLM system using change management for document releases/revisions.
  • Exchange information within functional area and Business Units to resolve and align label and IFU content
  • Review the work of others in functional area and provide critical feedback to assure quality.
  • Initiate and assist with continuous improvement endeavors in functional area.
  • Communicate data/metrics associated with functional area as required.
  • Support relevant NCs and CAPAs, monitor their progress and drive through to completion for all action items pertaining to label and/or IFU issues, including problem solving to resolution, root cause analysis and implementation of correction.
  • Assist with selection of external services related to functional area (printing, graphics, translations, etc.)
  • May provide reviews of regulatory documents (Technical Documents/GSPRs) to ensure labeling references are correct
  • May assist with internal and external regulatory audits

If requested, assist software engineers with translation/localization of graphical user interfaces (GUI).

Work From Home: Occasional

Travel Percentage: 0%

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