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The Content Writer (Medical Device) will author, review, update, and maintain technical content, including, but not limited to, reference guides, user manuals, instructions for use (IFUs), and package inserts.
Job Responsibility
Craft and deliver content in MadCap Flare, leveraging condition tags and variables, content reuse strategies, and multichannel publishing outputs (especially so for PDF publishing)
Develop, update, and maintain content, including, but not limited to, reference guides, user manuals, instructions for use (IFUs), and package inserts
Assist in design control processes, ensuring timeliness, accuracy, and compliance
Contribute to process improvement efforts related to style guides, templates, and publishing workflows
Review design deliverables, risk management documentation, and verification/validation documents for consistency with instructions for use (IFUs) content
Execute documentation changes through formal change control (ECO)
Work closely with internal teams (Marketing, Regulatory Affairs, Quality, and Engineering) to ensure documentation alignment with product requirements
Translate specialized product needs, customer needs, operational policies and processes, and product use into feasible documentation requirements and recommendations
Leverage knowledge of industry topics and business functions in executing core job functions
Perform additional duties as needed
Requirements
Bachelor’s degree in English, Health Sciences, Communication, Marketing, or related field
3-5+ years of technical writing, content management, and/or digital publishing experience in the medical device industry (required)
Minimum of 3 years’ experience utilizing MadCap Flare for technical writing and content management (required)
Excellent written and verbal communication skills
Proficiency in desktop publishing tools, such as Microsoft Office Suite, MadCap Flare, and Adobe FrameMaker
Familiarity with global labeling requirements
Excellent understanding of structured documentation and document version control
Detail-oriented and highly organized with a demonstrated ability to manage competing priorities
Ability to work independently and collaboratively to deliver quality results