Technical Writer

📋 Description Create bioanalytical reports, plans, and submission docs for internal BioAgilytix projects. Extracts data from LIMS, Gen5, FACs, and Excel for Word reports. Applies FDA/IMA/GxP/EMA/SEND/eCTD guidelines and SOPs in all documentation. Uses ZenQMS and SharePoint for document creation and management. Collaborates with leadership and scientists to manage deliverables and study timelines. Performs second-level technical review before PM review. 🎯 Requirements Understands scientific data and delivers clear reports. Familiar with lab-based methods and data outputs. Experience with FDA/IMA/GxP/EMA/SEND guidelines. Editorial/style conventions for FDA submissions and eCTD. Excellent written and oral communication. Proficient in Microsoft Office and Adobe Acrobat; Word templates. 🎁 Benefits 6-month contract duration. Primarily remote with occasional in-office visits. Full-time 40 hours/week. Not eligible for company-sponsored benefits.