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Planet Pharma

Technical Writer

Planet Pharma, Minneapolis, Minnesota, United States,


As a Technical Writer, you will support the production of customer facing product documentation, including but not limited to: user guides, service manuals, and instructions for use (IFUs). This includes both clinician and patient labeling that accompanies medical device products within the Neuroscience portfolio. You may work on R&D projects such as new product development and released products maintenance.Typical responsibilities may include:Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating CO/CA release.Revise, edit, and format legacy product documentation as required, including but not limited to user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).Ensure compliance of labeling with all applicable regulatory/QSR requirements.Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation).Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.Continually review the document development process to ensure quality in labeling output.

Nice to Have:Experience working in a federally regulated environment (FDA)Experience with the European Union Medical Device Regulation (EUMDR)Familiarity with Quality/CAPA processes and principalsSelf-directed and highly organizedAbility to manage multiple prioritiesExcellent communication skillsAdvanced writing/editing skillsCross-functional collaborative natureProduct Lifecycle Management software experienceMedical terminology experienceFamiliar with the principals of neuromodulationProduct development workflow

Pay Range: $30-42/hr*** Based on experience