Planet Pharma
Technical Writer (Engineering)
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 (e.g., sustaining activities and legacy document updates), as well as quality- and compliance- driven projects to ensure our labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g., FDA, EU MDR, ISO, etc.). You will be responsible for both the content in the labeling as well as the supporting documentation, which may include design plans, design input requirements and tracing documents, review documentation, and verification reports. You may also be responsible for investigation, documentation, and resolution of labeling-related quality issues.
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
Top 3 skills sets required:Technical writing / documentation skillsTime management skills – self-directedCommunication skills – comfortable interacting with engineers, scientists, and business leaders
3 main responsibilities:Writing/updating IFU/manual content to address quality related issues (corrections, clarifications, etc.)Conducting cross-functional reviews of labeling changesDocumenting labeling development activities per process
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
Top 3 skills sets required:Technical writing / documentation skillsTime management skills – self-directedCommunication skills – comfortable interacting with engineers, scientists, and business leaders
3 main responsibilities:Writing/updating IFU/manual content to address quality related issues (corrections, clarifications, etc.)Conducting cross-functional reviews of labeling changesDocumenting labeling development activities per process