Scientific Technical Writer - Development

About Freenome 

Freenome is a high growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

As a Scientific Technical Writer 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.

Your contribution:

• 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.
• Proactively 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

Your background, perspective and experience: 

• Bachelor’s degree required. Advanced degree in chemistry, biochemistry, material science, bioengineering, molecular biology, or genetics preferred
• 3+ years’ experience as a technical writer in relevant industry, (biotech, medical device, scientific equipment) focused on scientific or regulatory writing or the equivalent
• Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work
• Experience writing documentation for IVD product development projects
• 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 working on technical submissions to the FDA and/or European Regulatory Agencies
• Experience with verification and validation protocols/reports
• Demonstrated ability to thrive in fast-paced, highly interdisciplinary environment with rapidly changing priorities
• Experience with collaborative documentation systems is strongly preferred

COVID safety:

Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.

Funding

We have raised more than $1.1B from leading investors like Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. 

Freenomers

A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career. 

Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

Benefits include but are not limited to:

• Competitive compensation 
• Pre-IPO equity
• Flexible PTO (exempt) and generous PTO (non-exempt) 
• Comprehensive health coverage, including medical, dental, and vision 
• Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
• 401(k) plan 
• $250.00 new hire stipend to enhance your home office experience
• Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts 

# # # 

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)

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome.  Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee. 

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. 

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.