Scientific Technical Writer III (Contractor)

August 13

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Freenome

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Spot the pattern. Treat the cancer.

molecular diagnostics • multiomics • machine learning • biotechnology • cancer screening

201 - 500

💰 $290M Corporate Round on 2022-01

Description

• 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

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