GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

POSITION SUMMARY

GRAIL is seeking a technical writer to support documentation needs for research, development, and operations activities, in a highly regulated medical device environment. Documentation needs include scientific study protocols and reports, laboratory standard operating procedures, project plans and reports, and regulatory submissions. You would be joining a small team of technical writers, integrated with various functions across GRAIL. As part of the greater Program Management Organization, you would also collaborate with project and product managers in tracking documentation deliverables. Although location in the San Francisco Bay Area is preferred, this position can be remote.

You will:

• Track documentation and work with functional leads to ensure its timely completion
• Work with Quality, Regulatory, and other key stakeholders to create guidelines and templates for technical documents, SOPs, and work instructions
• Collaborate with Document Control to standardize document formats and styles across the organization
• Assist in creating, reviewing/proofreading, and updating SOPs and work instructions as neededAssist in writing and editing plans, specifications, batch records, and study protocols and reports, including verification and validation studies for reagents, assays, and automation 
• Assist in formatting experimental data for presentation and documentation
• Assist with preparing documentation for regulatory submissions
• Other responsibilities as needed

Your background should include:

• 2+ years of experience in a regulated environment (Life Sciences or Health Care highly preferred), with significant responsibility for documentation development
• Bachelor’s degree or higher in a Life Sciences or related field
• Demonstrated excellent written and oral communication skills
• Demonstrated experience preparing technical documentation that can be understood by a non-technical audience
• Demonstrated ability to transfer large and complex data sets, into formal documentation for a non-technical audience
• High Proficiency in MS Office and Google Suite
• Excellent attention to detail, balanced with the ability to calibrate the level of detail to the target audience
• Excellent organizational skills to work independently and help others manage their documentation deliverables
• Ability to quickly learn scientific and compliance concepts
• Ability to clearly communicate with stakeholders from a wide range of backgrounds
• Ability to collaborate with stakeholders and produce high quality work under tight timelines
• Ability to independently manage day-to-day schedule and priorities
• Ability to quickly adapt to changes in a constructive and creative manner
• Comfort with new technology and productivity tools




ADDITIONAL DESIRED QUALIFICATIONS




• Experience with product development under design control or in similar regulated environment is highly desired
• 3+ years of biotechnology industry experience
• Project management experience or trainingFamiliarity with general lab processes and procedures

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.