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