Location: Mounds View, MN
Duration: 12 months (potential contract to hire)
Provide technical writing and project management support for medical device product labeling projects within CVG Technical Communication. Deliverables are Instructions for Use (IFUs), which can include clinician reference manuals, device implant and technical manuals, product inserts, patient manuals, and online and mobile app content. Users of this information may include regulators, clinicians, patients, and technical support representatives. May be asked to move quickly between project work and process development and do both writing and project mgmt. Need to be energized by change and able to stay flexible.
- Plan, research, and develop content or coordinates content development for technical writing projects
- Prioritize appropriately and juggle responsibilities on multiple assigned projects
- Identify and write requirements and ensure appropriate requirements flowdown from system requirements through IFU deliverables
- Research products by reading product specifications and other documentation, interviewing subject matter experts, and investigating prototype hardware and software
- Influence project teams and business partners to support IFU strategy changes enabling innovation and burden reduction.
- Support project teams as necessary, including facilitating decisions about distribution and local language plans and regulatory requirements, researching justification for historical changes to content, etc.
- Maintain awareness of and ensure adherence to standards, laws, and process and content-related regulatory requirements, as well as internal procedures
- Develop, communicate and maintain project estimates, schedules, and status
- Coordinate layout and design of deliverables with graphic designer and/or print specifications expert
- Conduct informal and formal content and verification reviews
- Build and maintain successful business relationships
- Coordinate translations
- Maintain project-related records, working within a variety of document control and configuration management systems, processes and tools
- Apply creativity to solve problems related to processes, systems, and tools
- BA/BS in Technical Communications or related field
- 1-5 years of writing experience
Other Desired experience:
- Developing content in compliance with FDA Design Controls.
- Developing customer content within software Agile development environment.
- Writing online/mobile content using DITA.
- Recent experience working in regulated industry, and using Framemaker, XML content management systems, and document control/configuration mgmt. systems
- Some project management experience preferred (certification not necessary)