Technical Writer, Product Development

About the role

Universal DX is seeking a Technical Writer to join its Product Development organization in a critical capacity focused on documentation ownership for Signal-C and next generation sequencing (NGS)-based in vitro diagnostic products. The hire will be responsible for translating complex molecular assays into precise, compliant documentation that supports regulatory submissions, analytical validation, and design control activities across the product lifecycle. You will own the end-to-end documentation lifecycle, ensuring that every narrative, protocol, and user instruction meets stringent FDA expectations while remaining clear and actionable for both internal teams and external partners. This is a hands-on role that demands a strong scientific foundation, meticulous attention to detail, and the ability to synthesize highly technical information into structured, logical documents. You will partner closely with subject matter experts in molecular biology, bioinformatics, and regulatory affairs to ensure documentation accuracy and consistency. The organization is developing multi-cancer screening technologies using multi-omics and bioinformatics approaches that rely on precise documentation to define methods, ensure traceability, and support commercialization. As a Technical Writer, you will directly contribute to the development of tests designed to detect cancer in its earliest stages through blood-based sampling by creating the documentation backbone that guides development and regulatory strategy.

Key facts

What you'll do

• Draft intake documents that define assay objectives, scope, and constraints for Signal-C and pipeline initiatives, establishing clear boundaries and deliverables.
• Design document architectures that map workflow stages from sample intake through build, validation, and release, ensuring logical flow and regulatory alignment.
• Draft protocols and user instructions that mirror actual laboratory procedures and NGS data analysis decision points, reflecting real-world operational practices.
• Review validation reports and regulatory checklists to confirm content completeness and traceability, identifying gaps and ensuring all requirements are met.
• Prepare shipping and logistics documentation to ensure kits and samples move through supply chains without error, minimizing risk of misrouting or handling issues.
• Structure partner-facing materials that clearly explain testing capabilities and turnaround timelines, balancing technical accuracy with accessibility for external stakeholders.
• Maintain version histories and change logs to document the evolution of materials across project phases, providing an auditable trail of documentation decisions.
• Synthesize feedback from reviewers to refine clarity, accuracy, and regulatory alignment, iterating on drafts until they meet required standards.
• Translate dense data into accurate instructions without unnecessary complexity, making sophisticated molecular processes understandable to target audiences.
• Ensure all documentation supports design control activities by clearly linking requirements, specifications, and verification activities throughout development.
• Contribute to the creation of regulatory submission documents by producing high-quality content that meets agency expectations for clarity and completeness.
• Collaborate with bioinformatics teams to accurately represent data analysis workflows and interpretation rules in user documentation and protocols.
• Participate in cross-functional reviews to validate that documentation correctly reflects the intended product behavior and user needs.
• Identify and document edge cases and exceptional scenarios in assay workflows to ensure comprehensive procedural coverage.
• Support the development of training materials for laboratory staff and clinical partners to ensure consistent implementation of documented procedures.

Requirements

• You hold a degree in a scientific discipline or possess four years of relevant experience in technical communication, demonstrating your ability to operate in regulated environments.
• You can convert molecular assays and NGS workflows into step-by-step procedures that experts can follow reliably, ensuring operational consistency and accuracy.
• You write precise procedures that support design control, validation, and regulatory review processes, understanding how documentation interfaces with regulatory expectations.
• You engage effectively with subject matter experts to close information gaps and verify technical content, building productive working relationships across disciplines.
• You are capable of producing substantive first drafts, identifying missing information, and contributing to scientifically accurate documentation that withstands regulatory scrutiny.
• You demonstrate strong attention to detail and commitment to regulatory compliance, ensuring all documentation meets applicable standards and requirements.
• You possess the ability to manage multiple documentation projects simultaneously while maintaining quality and meeting established deadlines.
• You have strong written communication skills and can structure complex information in a logical, coherent manner that supports user comprehension and regulatory review.

Nice to have

• Experience with colorectal cancer screening or liquid biopsy platforms provides context-specific understanding of the clinical implications and user needs.
• Familiarity with clinical laboratory improvement amendments (CLIA) and regulatory frameworks ensures awareness of the compliance landscape for diagnostic documentation.
• Proficiency with Signal-C, Next Generation Sequencing, Microsoft Office, Confluence, and Jira represents expected technical skills for navigating the documentation ecosystem and collaborating effectively within established workflows.

Practical notes

• Please Ensure your application reflects your experience with diagnostic documentation and your commitment to accuracy and regulatory standards.