Technical Writer
Skills
BriefingCommandContinuous ImprovementMedical DevicesMinutesProject CoordinationRegulatory Documentation
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Master’s or Ph.D. in a life-science or related field
- 3+ years in NGS IVD assay development analytical validation scientific writing or regulatory documentation
- Primary authorship or substantial drafting of complex technical documents
- Hands-on knowledge of NGS workflows assay performance quality metrics study designs and bioinformatics or software outputs
- Experience preparing or editing FDA-facing documents and responses
- Strong scientific and technical writing skills with ability to create new content from incomplete SME inputs
- Experience supporting controlled documents in a QMS environment
- Excellent document management and project coordination skills including version control and comment reconciliation
- Working knowledge of FDA and IVD medical device expectations including design controls analytical validation and risk management
Nice to have
- Scientist by training
- Detail-oriented
- Cross-functional collaborator
- Hands-on writer
- Regulatory-minded
Day to day
- Draft and revise FDA-facing technical documents for NGS-based diagnostic products, including submission packages meeting books slides and agency responses
- Write analytical validation and verification protocols and reports with clear study rationale methods acceptance criteria results and conclusions
- Collaborate with Product Development Regulatory Affairs Quality Assurance and SMEs to turn complex assay and bioinformatics inputs into accurate submission-ready content