Senior Technical Writer - Product Labeling

Requisition ID:  33837  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

We are seeking an experienced and self-motivated Senior Technical Writer to support the development of high-quality documentation for our medical device product lines. This role involves creating and managing technical content—including Instructions for Use (IFUs), user guides, and design control documents—within a regulated environment. You’ll collaborate with cross-functional teams and subject matter experts to ensure content accuracy, compliance with FDA and international standards, and alignment with business objectives. The ideal candidate has at least 7 years of experience in medical technical writing, a strong command of XML/DITA-based content management systems, and a proven ability to write for global audiences. If you're passionate about clear, user-focused communication and thrive in a fast-paced, collaborative setting, we’d love to hear from you.

 

ESSENTIAL DUTIES

• With guidance from department manager and senior staff members, works with internal customers and various subject matter experts (SMEs) to produce technical content of moderate to high complexity in support of assigned product lines.
• Create content: write new content, make changes/edits to existing content, gather the correct content from the content management system (CMS), and apply metadata to content.
• Completes design control documents for lower-level requirements and verification of content prior to release.
• Verifies content based on lower-level requirements and product requirements acceptance criteria.
• Frequently makes decisions on routine matters, clearing all non-routine issues with department manager or lead content developer.
• Forecasts and meets project deadlines. Takes the initiative to report on project status; anticipates and alerts manager and internal customers of potential project difficulties.
• Manage all phases of content development projects, including needs assessment, affected deliverables, and timelines, content management & development, review schedules, and release activities.
• Assists in the maintenance of art, photo, and electronic and printed document files to meet departmental and regulatory requirements.
• Stays current with regulations and standards that apply to assigned products.
• Completes gap assessments of content to comply with current and revised FDA standards and regulations.
• Maintains advanced knowledge of assigned products and the therapies in which they are used.
• Facilitates discussions and represents Technical Communication team.
• Clarifies and maintains departmental policies and procedures.
• Leads process improvement initiatives.
• Seeks on-going knowledge of industry, regulatory, linguistics, and publication standards and applies this knowledge to the completion of all projects.

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

• Minimum 7 years’ experience.

 

Skills

• Ability to understand businesses’ products and the therapies in which they are used.
• Functional knowledge of medical device industry and regulatory affairs,