BarnAllen has an immediate need for a Technical Information Specialist for our FDA project located in White Oak, Silver Spring, MD.

Essential Duties and Responsibilities:

• Analyze incoming documents and reports for completeness and compliance with the customer’s guideline
• Take appropriate steps to capture the pertinent information into databases and IT systems.
• Perform accurate and timely data entry using multiple screens in customer’s system
• Classify/index/assign the records appropriately.
• Maintain paper and electronic records in accordance with customer’s established guidelines
• Collect statistics and assist in providing input for periodic reports.

Requirements:

• Minimum of 3 years of increasingly responsible experience in records and document management
• Must type at least 40WPM
• Proficient in reading, analyzing, classifying, and interpreting complex narrative of regulatory submissions
• Experience in document processing and related quality control activities
• Experience in document tracking, records inventory, and scanning
• Must be able to implement SOPs and train staff in their use
• COVID-19 vaccine and proof of full vaccination required

Skills:

• Must be proficient in using computers, demonstrated use of Microsoft Office
• Excellent verbal and written communication
• Excellent demonstrated customer service skills