Full-Time Technical Writer

Role and Responsibilities

Responsibilities may include the following and other duties may be assigned.

• Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
• Write clear, simple content that speaks to customers in their own language. Understand the impact of localization on English content and writing for a global audience.
• Effectively communicate the appropriate level of detail based on technical and customer requirements.
• Collaborate openly and effectively with a range of stakeholders, including writers and subject matter experts.
• Understand how regulations, laws, and standards influence content design.
• Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
• Manage multiple projects and communicate status proactively. Successfully negotiate project schedules, plans, and milestones.
• Contribute to time and cost estimates for labeling deliverables for project teams.
• Take direction to be able to work independently and make sound decisions. Express ideas clearly and diplomatically.
• Develop documentation for regulatory submissions and maintain design documentation to support quality and regulatory process requirements.
• Assist in providing documentation for CAPAs, and departmental and business-unit audits.
• Participate in department and business-unit initiatives.
• Oversee change order process for labeling.
• Coordinate translations and track the status of translations.
• Additional tasks as assigned.

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.

• Bachelor's degree
• Minimum of 2 years of communications, labeling, and/or technical writing experience
• Advanced degree with 0 years of communications, labeling, and/or technical writing experience

Nice to Have (Preferred Qualifications):

• Exceptional writing and communication skills
• Excellent problem-solving skills
• Self-directed and highly organized
• Strong attention to detail and accuracy
• Experience working with cross-functional project teams
• Experience authoring in XML within a content management system
• Experience creating content for software or apps and managing software documentation projects
• Experience using product lifecycle management (PLM) software
• Demonstrated ability to meet deadlines and manage multiple priorities
• Ability to work effectively across disciplines to implement creative solutions to complex problems
• Knowledge of Medtronic products and quality systems
• Knowledge of formal reviews and system validation processes. Knowledge of software technologies used for writing, publishing, and document control
• Knowledge of structured writing and minimalism
• Aptitude to learn new requirements, processes, and tools
• Understand industry trends in technical communication, information
• architecture, and content development
• 2+ years of experience as a technical/medical writer in the medical device, scientific, or other regulated industry