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.