Comrise · 1 day ago
XML Technical Writer
Comrise is a company seeking an XML Technical Writer to assist in the development and completion of various clinical documents. The role involves overseeing the electronic regulatory submission process, providing guidance for document development, and managing timelines for technical documents while working independently.
Responsibilities
Assists in the timely development and completion of clinical reports, summary documents, package inserts and other documents
May oversee the electronic regulatory submission process
Oversees and provides recommendations for the development of formats and guidelines for documentation
Provides guidance and direction for completion and development of clinical and pre-clinical documents
Ensures effective planning and management of timelines for all aspects of technical documents
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision
Primary focus: Technical writing and document updates
Secondary focus: Label updates, which are largely data management–driven rather than writing-intensive
The labeling work is managed through specialized software and is less about content creation and more about structured updates within the system
Transitioning documents into structured files
Ensuring accuracy, formatting, and compliance within the system
Primary focus on the remediation of IFUs and labels to the latest regulation and standards for electronic IFUs
IFU remediation may require conversion of the IFUs from Adobe source files to DITA xml within a content management platform (preferred experience: Arbortext/Windchill), and updates to the content
Label remediation may include creating new label templates and the creation of new labels in Prisym and Adobe platforms
Other tasks may include creating documentation demonstrate compliance to the latest regulation and standards for electronic IFUs, creation of part numbers and change management
Qualification
Required
Professional mastery of a specialized field of expertise that typically requires a college degree or equivalent
Professional knowledge gained through substantial applicable work experience
Attention to detail in making evaluative judgements based on the analysis of factual information
A minimum of 4 or more years' experience
Ability to work independently
Ability to collaborate cross-functionally
Ability to engage with multiple stakeholders to keep projects moving forward
Preferred
Experience with XML-based content management platforms
Familiarity with tools such as Arbortext, Windchill, or similar XML systems
Experience with Adobe platforms (e.g., InDesign)
Life sciences experience
Strong data management skills and technical aptitude may substitute for direct labeling experience
Company
Comrise
Headquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company.
H1B Sponsorship
Comrise has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (11)
2023 (9)
2022 (7)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageCompany data provided by crunchbase