Freenome is hiring a
Scientific Technical Writer III

Summary

The job is for a Scientific Technical Writer III at Freenome, a growing biotech company specializing in early cancer detection through a multiomics platform. The role involves writing and editing documentation for IVD product development projects, collaborating with cross-functional teams, and adhering to regulations and standards.

Requirements

• Bachelor’s degree in chemistry, biochemistry, material science, bioengineering, molecular biology, genetics, or relevant field is required
• 5+ years’ experience as a technical writer in relevant industry, (biotech, medical device, scientific equipment) focused on scientific or regulatory writing or the equivalent
• Experience writing documentation for IVD product development projects
• Experience working on technical submissions to the FDA and/or European Regulatory Agencies
• Experience with verification and validation protocols/reports
• Demonstrated ability to prioritize multiple projects and assignments simultaneously
• Demonstrated ability to work cross-functionally
• Demonstrated ability to thrive in fast-paced, highly interdisciplinary environment with rapidly changing priorities

Responsibilities

• Provide documentation writing expertise to support IVD product development projects for Freenome’s diagnostic programs
• Collaborate on project teams with scientists, engineers, and other functional stakeholders to develop technical documentation supporting assay/test development, design verification, and design validation activities
• Independently manage document reviews and approvals per established approval process within project schedule
• Understand processes from both the perspective of the user and the quality system
• Promote document best practices across projects; contribute to document improvement initiatives
• Be well versed in scientific terminology and principles to produce complex scientific content
• Work efficiently and accurately in quality management systems, adhering to best practices and departmental standards for terminology, content management, and reuse
• Coordinate and maintain organized records of all supporting materials, document drafts, and versions
• Quickly learn and apply new tools, processes, and standards
• Demonstrate adaptability and forward thinking in the face of technological or organizational change
• Track to and adhere to regulations, standards and guidance that govern the processes documented within the Operations department umbrella (e.g., 21 CFR 820, ISO 13485, etc.)
• Review, understanding, and compliance with the Company’s HIPAA Security policies and procedures

Preferred Qualifications

• Advanced degree in chemistry, biochemistry, material science, bioengineering, molecular biology, or genetics preferred
• Knowledge of design control, quality, and regulatory compliance for the development of medical device and diagnostics products, preferably in the clinical diagnostics and IVD field
• Experience with collaborative documentation systems is strongly preferred