Technical Writer, Product Development

A bout our Company: Universal D X , Inc . is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test , we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers. The Opportunity : Universal DX is seeking a Technical Writer to join our growing Product Development team to support the development and commercialization of Signal-C and future Next Generation Sequencing (NGS)-based in vitro diagnostic products for early cancer detection. This role will author, edit, and coordinate high-quality technical documents supporting FDA-facing regulatory interactions, analytical validation, and internal design-control activities. We are particularly interested in a scientist by training who has developed strong technical writing skills and is intentionally pursuing a hands-on Technical Writer role. The successful candidate must understand complex assay-development and NGS content well enough to create substantive first drafts, identify missing information, and contribute scientifically accurate content in partnership with subject matter experts. You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier” How you’ll contribute: • Develop substantive first drafts and revise FDA-facing technical documents, including Pre-Sub/Q-Sub packages, PMA modules and supporting summaries, FDA teleconference briefing books and slides, meeting minutes, and written responses to agency feedback, using source documents, data summaries, prior agency feedback, and SME interviews. • Partner with subject matter experts across Product Development, Biostatistics/Bioinformatics, Regulatory Affairs, and Quality Assurance to understand technical decisions, identify content gaps and open questions, and convert multidisciplinary inputs into clear, scientifically accurate, submission-ready documents. • Draft and revise analytical validation and verification protocols and reports, including objectives, study rationale, design, methods, sample and replicate structure, acceptance criteria, deviations, results summaries, conclusions, and traceability to intended use and risk, under review by study owners and relevant SMEs. • Accurately describe NGS assay workflows, cfDNA specimen processing, assay controls and quality metrics, sequencing and bioinformatics outputs, software results, acceptance criteria, risks, limitations, and supporting evidence for regulated audiences. • Support preparation and revision of controlled documents within the quality management system, including procedures, work instructions, forms, design-control records, CAPAs, change-control documentation, and other verification/validation documents, as needed across Product Development, Quality, and other functions. • Integrate technical source materials, data, tables, and figures across cross-functional deliverables, ensuring consistency of terminology, claims, study descriptions, and supporting appendices. • Coordinate document review cycles, reconcile comments from multiple stakeholders, identify decision owners for unresolved issues, and move documents to timely approval while maintaining accurate revision history, document metadata, and document-control requirements within electronic document control and quality-system workflows. • Develop presentation materials and other written communications used for FDA teleconferences, internal governance reviews, and e…