Scientific Technical Writer

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.

About the Role

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 in support of IVD new product development. Document types will include SOPs, verification and validation protocols and reports, as well as high level plans and design review summaries. 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 SOP 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.
• Translate the needs of the user into functional process documents while maintaining compliance with regulatory and quality requirements.
• 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

About Freenome

COVID safety:

As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy.  If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster.  If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.

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.

Funding

We have raised more than $1.1B from leading investors including 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 

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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. 

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