Senior Scientific Technical Writer

Job Summary

A company is looking for a Senior Scientific Technical Writer.

Key Responsibilities

• Write and edit documents for IVD, LDT, CE Mark, and RUO product offerings
• Develop and manage timelines for document development and completion
• Interface with cross-functional teams to gather input for product development

Required Qualifications

• B.A./B.S. in biology, chemistry, or related field required; advanced degree preferred
• 10+ years of industry experience with a B.S., 8+ years with an M.S., or 5+ years with a Ph.D
• At least 3 years of wet-lab experience required
• Experience in biotechnology or pharmaceutical industries in a regulated environment required
• Familiarity with ISO 13485, ISO 14971, CLIA, CAP, CLEP, GxP, and other regulatory compliance requirements