Senior Technical Writer - Product Labeling

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, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects. Experience working in a highly regulated environment and development of design controls documents. Experience working with localization project managers and linguists. Experience writing for a global audience. Ability to collaborate and translate business objectives into tangible technical content for skill development at all levels. Demonstrated ability to communicate effectively both verbally and in writing/editing, graphic design. Organizing skills and the demonstrated ability for attention to detail. Excellent interpersonal skills and the ability to work effectively and comfortably with all levels within the businesses. Able to drive results seeing projects through completion. Demonstrates technical/functional skills to work in a content management system, XML, and various desktop publishing systems and willingness to learn Astoria. Understand and apply DITA models.

LOCATION

Lakewood, Colorado or Remote in the Continental United States.

Physical Requirements

Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:

$80,600.00 to $100,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base:

7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect – Appreciative of othersIntegrity – Guided by our missionCare – Empathetic to patientsQuality – Committed to excellenceCreativity – Striving for innovationWe contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.