• 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.
