This position will support FDA records management activities by conducting research, reviewing and analyzing information, performing quality control, maintaining accurate records, and ensuring compliance with established procedures and requirements. This is a
primarily remote position but may require
periodic travel to the FDA White Oak campus in Silver Spring, Maryland to support onsite activities, as needed.
Position SummaryThe Senior Technical Information Specialist will be responsible for conducting research, reviewing, analyzing, and performing quality control activities to ensure information is accurate, complete, and compliant with established procedures and requirements. This role involves researching information from multiple sources, evaluating data, updating records, resolving discrepancies, and maintaining accurate documentation. The position requires strong attention to detail, the ability to interpret guidelines and procedures, and effective communication with internal and external stakeholders.
Key Responsibilities- Conduct research using databases, online resources, and internal systems to gather and validate information
- Review, analyze, and update records to ensure accuracy, completeness, and consistency
- Identify discrepancies, determine appropriate next steps, and escalate issues when additional guidance is needed
- Perform quality control reviews to verify data accuracy and compliance with established procedures
- Document findings, updates, and decisions in tracking systems and required documentation tools
- Communicate with internal and external stakeholders via phone, email, and other communication methods to obtain and verify information
- Respond to questions and provide guidance based on established policies, procedures, and requirements
- Maintain organized records and ensure compliance with applicable records management standards
- Manage assigned workload independently while meeting established timelines, priorities, and service level requirements
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Requirements- Bachelor's degree required
- Minimum of 3 years of related experience in records management, document management, data review, quality control, or regulatory support
- Strong research, analytical, organizational, and problem-solving skills
- Excellent attention to detail with the ability to identify errors and ensure accuracy
- Strong verbal and written communication skills, including professional email and phone communication
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and database systems
- Ability to interpret and apply procedures, policies, and guidelines to complete assigned tasks
- Ability to work independently, prioritize multiple assignments, and meet deadlines with minimal supervision
- Must be eligible to work in the U.S. and able to obtain a government security clearance
- Experience supporting federal government or regulatory programs preferred
- Must have strong computer skills and the ability to learn new systems and software tools
- Ability to work primarily remotely with periodic travel to the FDA White Oak campus in Maryland
- Work schedule: Monday-Friday, 7:00 a.m.-5:30 p.m. (flexible)
