Why join Freenome?
Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.
At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.
About this opportunity:
As a Scientific Technical Writer III you will join a highly collaborative team and make an immediate impact on early cancer detection. You will support Freenome’s mission to facilitate the writing, editing, and release of documentation primarily in support of next generation sequencing (NGS) based IVD new product development. Document types will include development study, verification and validation protocols and reports, as well as unit testing protocols and reports. The successful candidate will interface broadly with key subject matter experts and cross-functional teams to deliver well-written documentation in a timely manner.
What you’ll do:
- 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
Must haves:
- 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
Nice to haves:
- 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
Additional information:
Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/for additional company information. Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
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