Technical Writer, Product Development at Universal DX

Job description

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 external regulatory discussions. • Maintain adherence to quality management system (QMS) requirements and document-control practices, and support continuous improvement of technical writing templates, standards, and authoring workflows. What you’ll bring: Required Qualifications • Master’s or Ph.D. in Molecular Biology, Biochemistry, Genetics, Genomics, Bioinformatics, Biomedical Sciences, Biomedical Engineering, or a related life-science field. • 3+ years of combined experience in NGS/IVD assay development, analytical validation, scientific or technical writing, or regulatory documentation in a regulated life-sciences environment. A prior Technical Writer title is not required if the candidate demonstrates substantial authorship of protocols, reports, validation documents, or FDA-facing content. • Demonstrated primary authorship or substantial drafting of scientifically complex documents, such as analytical validation protocols and reports, verification/validation documentation, design-control records, regulatory submission sections, meeting packages, or formal agency responses. • Hands-on knowledge of NGS workflows and the ability to understand assay performance, quality metrics, study designs, data tables and figures, and bioinformatics or software outputs sufficiently to draft accurate technical content. • Experience preparing or editing FDA-facing documents, preferably including Pre-Sub/Q-Sub submissions, PMA- or 510(k)-supporting documentation, FDA meeting materials, or written responses to agency feedback, as part of a cross-functional team. • Strong command of scientific and technical writing, with the ability to create new content from incomplete SME inputs and synthesize complex multidisciplinary information into concise, organized, audience-appropriate documents. • Experience supporting controlled documents in a QMS environment, including SOPs, protocols, reports, forms, procedures, design-control documentation, CAPAs, and change-control records. • Excellent document management and project coordination skills, including version control, comment reconciliation, template use, formatting discipline, attention to detail, and management of multiple document timelines. • Working knowledge of FDA and IVD/medical device expectations, including design controls, analytical validation and verification, risk management, and controlled-document practices, with proven ability to work effectively with cross-functional SMEs. Preferred Qualifications • Experience supporting NGS-based assays, liquid biopsy products, oncology diagnostics, and/or cfDNA methylation technologies. • Experience interpreting statistical analyses, bioinformatics outputs, software/QC documentation, and complex data tables and figures . • Experience contributing to FDA PMA, 510(k), Pre-Sub/Q-Sub packages, analytical validation protocols and reports, design history file content, and responses to agency questions. • Experience using electronic document control, quality-system, or collaboration platforms to support controlled-document workflows, change history, approval routing, and cross-functional review cycles across departments. What we´ll offer: We’re proud to offer exceptional corporate benefits which include: • 22 days of PTO with the possibility to carry over 10 days to the following year. • Company Holidays, plus your Birthday off! • Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k). • Flexible work schedule • And more to come! Why Now? This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

Requirements

Must-haves

Integrate technical source materials, data, tables, and figures across cross-functional deliverables, ensuring consistency of terminology, claims, study descriptions, and supporting appendices.
Develop presentation materials and other written communications used for FDA teleconferences, internal governance reviews, and external regulatory discussions.
Maintain adherence to quality management system (QMS) requirements and document-control practices, and support continuous improvement of technical writing templates, standards, and authoring workflows.
Master’s or Ph.D. in Molecular Biology, Biochemistry, Genetics, Genomics, Bioinformatics, Biomedical Sciences, Biomedical Engineering, or a related life-science field.
Experience supporting controlled documents in a QMS environment, including SOPs, protocols, reports, forms, procedures, design-control documentation, CAPAs, and change-control records.
Excellent document management and project coordination skills, including version control, comment reconciliation, template use, formatting discipline, attention to detail, and management of multiple document timelines.
We’re proud to offer exceptional corporate benefits which include:
22 days of PTO with the possibility to carry over 10 days to the following year.
Flexible work schedule
And more to come!
This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

Nice-to-haves

Experience supporting NGS-based assays, liquid biopsy products, oncology diagnostics, and/or cfDNA methylation technologies.
Experience interpreting statistical analyses, bioinformatics outputs, software/QC documentation, and complex data tables and figures .
Experience contributing to FDA PMA, 510(k), Pre-Sub/Q-Sub packages, analytical validation protocols and reports, design history file content, and responses to agency questions.
Experience using electronic document control, quality-system, or collaboration platforms to support controlled-document workflows, change history, approval routing, and cross-functional review cycles across departments.

Application prep

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Benefits

Benefits detected in the listing.

Dental

Vision

401(K)

Pto