Develops high-quality documentation that address laboratory testing technology, test selection, and test interpretation. Writes, edits, and/or reviews design control documents, abstracts, posters, and scientific manuscripts for publication at professional meetings or in peer-reviewed journals. Manages Design Control in vitro diagnostic (IVD) development documentation using validated document control systems providing technical expertise to Quality team to be compliant with CAP/CLIA regulations and IVD requirements. Creates drafts of critical documents, finalizes documents with input from the technical team, and manages documents through submission and approval in document control system. Provides guidance on documentation strategies and content based on experience with projects meeting IVD, USDA, CAP, and CLIA requirements. Performs these duties with minimal supervision.  Also has some project management responsibilities related to documentation needs. Reports to Executive Director Oncology, Research and Development.

• Assumes project management responsibilities for documentation aspects of IVD development projects.
• Provides direction or mentoring to IVD assay development team and quality team.
• Provides recommendations on how best to document development activities to support 21 CFR compliance.
• Writes and edits design control materials (Validation Test Plans, Validation Test Reports, Design Review Records, Compliance Testing Documentation).
• Writes or edits abstracts, posters, journal articles, and educational lectures.
• Obtains appropriate approvals.
• Interacts directly with Quality and Regulatory Team members to ensure development activities are appropriately documented to minimize program risk.
• Performs other functions of the medical information department as needed.

• Master’s or Ph.D. in a scientific or medical discipline with 5 or more years writing experience.
• Minor in English composition, technical writing, or journalism is a strong plus.
• Experience with IVD documentation needs required.
• Clinical laboratory experience is a strong plus.
• In-depth knowledge of design control principles and requirements.
• Proficiency in scientific information retrieval.
• Comprehension of technical literature and regulatory guidance documentation.
• Project management skills.
• Strong communication skills (written and oral).
• Intermediate level computer skills including word-processing and graphics.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets