POSITION SUMMARY:
As part of the Platform department, the Technical Writer will work with cross-functional teams to produce and improve our controlled documentation. A technical writer in our team will need to be able to understand both the business requirements and the technical details of the products to be able to effectively produce high-quality documentation. They will need to communicate with multiple stakeholders and R&D team members, and review development reports or team resources and software scripts to help derive information for documentation. This role will be responsible for documenting our design control environment for compliance audits as well as communicating complex technical information clearly to an audience of R&D scientists and clinical professionals.
PRIMARY RESPONSIBILITIES:
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Assemble documentation needed for regulatory compliance requirements including FDA 21 CFR Part 11, GCP, CAP / CLIA, HIPAA, CE, GDPR, etc.
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Investigate and learn the business processes and functionalities that need documentation.
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Create documentation for R&D and CLIA team members, such as training plans, departmental practice descriptions, and other onboarding documentation.
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Help ensure traceability is established across documentation for project deliverables.
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Identify and suggest improvements to processes and deliverables.
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Performs other duties as assigned.
QUALIFICATIONS:
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At least 5 years technical writing experience, preferably in the medical device or life science industry.
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BS or higher in related major or equivalent industry experience
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Experience working in a regulated environment and knowledge of compliance requirements for a medical device or IVD company: FDA 21 CFR Part 11, GCP, CAP / CLIA, HIPAA, CE mark, GDPR, etc.
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Experience understanding software implementations and writing examples for structured data input/output (JSON, XML).
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Experience working with multiple teams, including engineering, product management, data science, biostatistics, science, and regulatory and quality assurance teams as part of the product development process.
KNOWLEDGE, SKILLS, AND ABILITIES:
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Excellent written communication skills to produce clear, concise and correct technical documentation
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Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures
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Familiarity with documentation control and collaboration software like Confluence
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Familiarity with the Product Development Life Cycle
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Familiarity with change control management process
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Ability to take high degree of initiative and demonstrates motivation to work independently and be a self-starter.
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Useful domain knowledge: LIMS, LIS, LES, and/or ELN (especially LabVantage) Genetics and bioinformatics Genomics data analysis Laboratory processes and instrumentation Laboratory software compliance requirements
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
San Carlos, CA
$93,100—$116,350 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Top Skills
What We Do
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
Where some set out to build a test, we set out to achieve a mission: change the management of disease worldwide by using DNA testing to proactively inform treatment.
Through a cfDNA technology platform approach, we've pioneered noninvasive testing in unlimited applications—each with their own potential to revolutionize care for patients.
#TeamNatera includes clinicians, scientists, biostatisticians, researchers, and laboratory professionals from around the world. Our diverse teams blend a passion for patients with deep clinical, scientific, and technological roots. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy.
