OVERVIEW

DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.

PROJECT DESCRIPTION:

The Food and Drug Administration’s is seeking contractor support to help manage and improve systems used for electronic. The overall goal is to keep these systems reliable and up-to-date as regulatory requirements and technology evolve. The contractor will provide expertise on regulations and technical issues, support testing and implementation of new standards (like updates to electronic submission formats), deliver ongoing help desk and training services, and assist with daily operations. The work will also involve managing user questions, supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will help the FDA meet its obligations under recent legislation and ensure that its electronic submission platforms remain effective and secure.

JOB SUMMARY:

The Senior Functional Analyst will serve as the primary leader overseeing all help desk operations supporting electronic submissions on the project, managing user inquiries across multiple dedicated email mailboxes, and ensuring prompt, effective resolution of issues in accordance with stringent service level agreements (SLAs). This individual provides both Tier 1 and Tier 2 support, directs the triage and escalation of complex technical questions, and maintains comprehensive documentation, including FAQs and standard operating procedures, to ensure consistency and quality of support. The Lead applies advanced analytic methodologies to define project objectives, monitor performance metrics, and drive continuous process improvement, while also providing vision and leadership to both client and project teams. This role requires deep expertise in regulatory electronic submission standards, a strong background in analytic techniques, and a demonstrated ability to resolve complex problems and mentor junior staff, ensuring operational continuity and high levels of user and stakeholder satisfaction in a dynamic regulatory environment.

Responsibilities:

• Oversee daily operations and maintenance support for FDA electronic submission systems and mailboxes.
• Manage and triage incoming help desk requests across multiple dedicated mailboxes, ensuring timely documentation, classification, escalation, and resolution of user inquiries.
• Provide expert guidance on electronic submission specifications, FDA submission standards, and technical troubleshooting for complex issues, collaborating with subject matter experts as needed.
• Develop, maintain, and update knowledge base documentation, including FAQs and Standard Operating Procedures (SOPs), to ensure consistent and high-quality support.
• Coordinate and deliver user training logistics, including scheduling, materials preparation, and metrics tracking for FDA reviewers and industry sponsors.
• Implement process improvement recommendations to enhance efficiency and reduce manual workload in help desk operations.
• Monitor performance against service level agreements (SLAs), generate operational metrics, and report on help desk activity.
• Lead and mentor support staff to ensure effective customer service, adherence to quality standards, and operational continuity

Require Experience:

• Minimum 5 years of technical expertise providing Tier 1 and Tier 2 support services for electronic submission systems, including identifying, documenting, triaging, resolving, and escalating sponsor and internal user inquiries.
• Demonstrated experience supporting FDA electronic submission data standards and processes
• Experience developing, updating, and delivering comprehensive training programs and materials tailored to diverse stakeholder groups, including FDA reviewers and external sponsors.
• Proven ability to manage high-volume help desk operations (email/mailbox management, ticket triage, escalation, and resolution) in a regulatory or technical environment.
• Strong knowledge of FDA data standards and data exchange formats, including CDISC, SEND, and HL7.
• Demonstrated ability to develop and maintain knowledge base documentation, such as FAQs and SOPs, for consistent and high-quality support.
• Experience with process improvement initiatives to increase efficiency and reduce manual workload in help desk operations.
• Proficiency with Microsoft Office Suite (Excel, Outlook, SharePoint) and ability to quickly learn specialized FDA tools
• Excellent written and verbal communication skills for customer support, training, and documentation.
• Ability to coordinate and collaborate with cross-functional teams, including technical staff, subject matter experts, and government stakeholders.

Preferred Experience:

• Experience leading or mentoring support staff in a regulated or government environment.
• Prior experience supporting FDA/CDER or similar regulatory agency operations.
• Familiarity with FDA’s electronic submission systems.
• Experience supporting large-scale electronic submission programs for FDA or similar organizations.
• Demonstrated track record of meeting or exceeding service level agreements (SLAs) for help desk or support operations.
• Experience with process automation or knowledge management tools beyond Microsoft Office (e.g., ticketing systems, knowledge bases).
• Understanding of FDA’s operational policies, modernization projects, and ongoing electronic submissions implementation.
• Ability to support surge operations and adapt to changing priorities during peak submission periods.

Education & Training:

• BS/BA degree required
• IT Support/Help Desk Certifications preferred
• Project/Process Management Certifications (i.e. ITIL, LSS) preferred
• CSM preferred
• CDISC or HL7 Certification preferred

Salary Range:

• $110,000-$144,000
• Salary commensurate with experience.

• Oversee daily operations and maintenance support for FDA electronic submission systems and mailboxes.
• Manage and triage incoming help desk requests across multiple dedicated mailboxes, ensuring timely documentation, classification, escalation, and resolution of user inquiries.
• Provide expert guidance on electronic submission specifications, FDA submission standards, and technical troubleshooting for complex issues, collaborating with subject matter experts as needed.
• Develop, maintain, and update knowledge base documentation, including FAQs and Standard Operating Procedures (SOPs), to ensure consistent and high-quality support.
• Coordinate and deliver user training logistics, including scheduling, materials preparation, and metrics tracking for FDA reviewers and industry sponsors.
• Implement process improvement recommendations to enhance efficiency and reduce manual workload in help desk operations.
• Monitor performance against service level agreements (SLAs), generate operational metrics, and report on help desk activity.
• Lead and mentor support staff to ensure effective customer service, adherence to quality standards, and operational continuit