Technical Writer - Product Development

About Universal DX

Universal DX, Inc. is a global organization dedicated to deciphering cancer through advanced multi-omics and bioinformatics approaches. Our expertise enables highly accurate early-stage cancer detection via blood-based signals, starting with a colorectal cancer liquid biopsy test. We are expanding our efforts to develop a multi-cancer detection platform targeting unique DNA markers associated with various cancers.

Role Overview

We seek a Technical Writer to join our expanding Product Development division to support creation and commercialization of Signal-C and forthcoming Next Generation Sequencing (NGS)-based in vitro diagnostic tests for early cancer detection. The successful candidate will produce, edit, and coordinate technical documentation for FDA regulatory submissions, analytical validation, and design-control processes.

This position is ideal for scientifically trained candidates eager to apply their knowledge in technical writing, who understand complex assay development and NGS well enough to draft detailed content, identify gaps, and collaborate closely with subject matter experts.

Key Responsibilities

• Compose initial drafts and revise FDA submission documents including Pre-Sub/Q-Sub packages, PMA modules, briefing materials, meeting minutes, and formal agency responses based on source data, feedback, and SME input.
• Collaborate with cross-functional experts in Product Development, Biostatistics, Regulatory Affairs, and Quality Assurance to grasp technical decisions, identify missing content, and prepare scientifically accurate, submission-ready documents.
• Develop and update analytical validation and verification protocols and reports covering study objectives, rationale, design, methodology, acceptance criteria, deviations, outcomes, conclusions, and traceability to intended use and risks.
• Provide accurate descriptions of NGS assay processes, cfDNA specimen management, assay controls and quality measures, sequencing and bioinformatics outputs, software results, and associated limitations for regulated audiences.
• Support preparation and revision of quality management system (QMS) controlled documents including procedures, work instructions, forms, design-control records, CAPAs, change-control documentation, and verification/validation materials across various functions.
• Integrate and ensure consistency of technical data, tables, figures, and terminology across multidisciplinary deliverables.
• Manage document review cycles, resolve reviewer comments, identify decision makers, and ensure timely approvals with meticulous version control and document metadata management within electronic quality systems.
• Create presentation materials for FDA teleconferences, internal reviews, and external regulatory discussions.
• Maintain compliance with QMS requirements, document-control protocols, and contribute to improvements in writing templates, standards, and workflows.

Mandatory Qualifications

• Master’s or Ph.D. degree in Molecular Biology, Biochemistry, Genetics, Genomics, Bioinformatics, Biomedical Sciences, Biomedical Engineering, or related life science field.
• At least 3 years of combined experience involving NGS or IVD assay development, analytical validation, scientific/technical writing, or regulatory documentation in regulated life sciences contexts, with evidence of substantial document authorship.
• Proven capability to author complex scientific documents such as validation protocols, reports, regulatory submissions, meeting packages, or formal agency responses.
• Hands-on understanding of NGS workflows, assay performance metrics, study designs, data interpretation, and bioinformatics or software results to produce precise technical narratives.
• Experience in preparing or editing FDA-facing regulatory documents including Pre-Sub/Q-Sub submissions, PMA/510(k) support, FDA meeting materials, or responses to agency feedback as part of cross-functional teams.
• Strong scientific and technical writing skills, capable of creating cohesive documents from incomplete inputs and synthesizing complex information for relevant audiences.
• Experience with controlled documents within QMS, including SOPs, protocols, reports, forms, design control documents, CAPA, and change control records.
• Excellent documentation management and project coordination—version control, comment reconciliation, formatting, attention to detail, and managing concurrent timelines.
• Familiarity with FDA and medical device/IVD regulatory expectations covering design controls, validation, risk management, and document control, with proven collaboration across functions.

Preferred Skills

• Experience with NGS-based assays, liquid biopsy, oncology diagnostics, and cfDNA methylation technologies.
• Ability to interpret statistical, bioinformatics, software, and quality control data outputs.
• Experience contributing to FDA PMA, 510(k), Pre-Sub/Q-Sub packages, validation protocols, design history files, and formal agency communications.
• Proficiency using electronic document control and quality-system platforms to manage controlled-document workflows, revisions, approvals, and cross-departmental reviews.

Benefits

• 22 paid time-off days yearly, with up to 10 days carryover allowed.
• Company holidays plus an off day for your birthday.
• Comprehensive company-sponsored benefits including medical, dental, vision insurance, life insurance, short- and long-term disability coverage, and 401(k) retirement plan.
• Flexible work schedule.
• Additional benefits as the company expands.

Additional Information

This is a pivotal time for Universal DX, with rapid growth, US operational launch including labs and business units, and forming strategic alliances. Join us as a passionate changemaker committed to advancing early cancer detection to make cancer curable through earlier intervention.