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Role Description

We are seeking a highly motivated Senior Scientific Technical Writer with technical writing expertise for design control documents including protocols, technical summary reports, risk documents, that support regulated and non-regulated design and development and design transfer activities. The successful candidate will interface broadly with R & D staff members and cross functional teams.

• Write and edit documents required to develop products for IVD, LDT, CE Mark, and RUO product offerings
• Develop and manage timelines for document development and completion
• Interface with cross functional teams including business development, computational biology, software, quality assurance, operations and validation teams to seek input for product development
• Understand NGS immunosequencing PCR assays, sequencing data and statistical analyses
• Developing assays under design control
• Multiplex PCR, and NGS technology preferred
• Proficiency in verbal and written English
• Demonstrated capacity for problem solving and identifying solutions
• Must work independently and be able to prioritize and manage multiple projects
• Proficiency in Microsoft Office, Microsoft Excel, Microsoft Project is required
• Knowledge of database tools such as Tableau, Visio or similar tools is desired
• All other duties as assigned

Qualifications

• Education: B.A./B.S. in biology or chemistry or related field (molecular biology, immunology, etc.) required. Advanced degree preferred (MS or Ph.D.)
• Years of industry experience: B.S., 10+ years, M.S. 8+ years, or Ph.D. 5+ years
• At least 3 years of wet-lab experience required
• Experience in the biotechnology or pharmaceutical industries and working in regulated environment is required
• Experience with ISO 13485, ISO 14971, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements is required

Requirements

• #LI-Remote

Compensation

• Salary Range: $128,700 - $193,100
• Other compensation elements include: equity grant, bonus eligible

Benefits

• Adaptive is committed to building diverse, equitable, and inclusive teams across our organization