Pr. Technical Writer, Labeling

ESSENTIAL JOB FUNCTIONS  

This position designs, develops and updates product shelf box and sterile tray labels, product manuals, quick reference guides, and other customer-facing technical documentation for existing medical device products. As a subject matter expert (SME), this position will collaborate with other team members across the organization including Manufacturing, Quality, Development, Marketing, Clinical Research, Regulatory Affairs, and contract manufacturers to define and maintain product labeling requirements while ensuring the labeling is accurate, visually appealing, cost-efficient, manufacturable, and compliant with applicable regulations, industry standards, and company requirements.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE  

• Work with product stakeholders to develop and implement geography specific and global labeling strategies for existing products.
• Work with internal and external stakeholders to define and manage labeling deliverables for existing products including product manuals, quick reference guides, shelf box labels, sterile tray labels, and other customer-facing technical documentation.
• Attend project meetings and communicate with stakeholders as necessary to define and maintain product labeling requirements.
• Evaluate, troubleshoot, and maintain existing templates, and design new templates where needed.
• Develop text, simple graphics, and update illustrations for labeling deliverables.
• Develop and manage the tools needed (e.g., terminology sheets and style manuals) that ensure consistency across UI terminology and labeling deliverables.
• Coordinate with contract manufacturers on creating and updating label printing files and ensure labeling requirements can be met.
• Create and manage change requests for labeling change approval and release.
• Communicate labeling deliverable timelines to cross-functional team and project manager.
• Prepare deliverables for printed, e-labeling, or on-line help delivery.
• Coordinate with translation vendor.
• Perform first article inspections on labeling.
• Manage multiple projects concurrently, while complying with good manufacturing practices, quality systems standards, and FDA and global labeling regulatory requirements.
• Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required: 

• 5+ years of labeling experience and/or technical writing experience from a regulated medical manufacturing industry (i.e. medical device or pharmaceutical, etc.)
• Demonstrated experience managing multiple projects simultaneously
• Proficiency with Adobe FrameMaker, In-Design and Creative Suite
• Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership
• Proficient with MS Suite (Word, Excel, Outlook)
• Bachelor’s Degree in Technical Communication or a related discipline

Preferred:

• 8+ years of labeling experience and/or technical writing experience in medical device manufacturing
• Proficiency with other label software packages such as Bartender, NetSuite, Loftware, Label View or Label Live

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