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 a highly knowledgeable authority in their designated field or discipline, providing valuable insight and strategic advice to guide tasks and project outcomes. This role involves addressing complex problems that require in-depth subject matter expertise and applying specialized principles and methodologies to develop effective solutions. The Senior Expert may participate in the evaluation, analysis, and development of recommended approaches, and is skilled in management consulting and facilitating collaboration across senior management teams. Areas of expertise may include business process reengineering, statistical process control, organizational assessment and evaluation, process modeling and simulation, strategic and business planning, change management, organizational development, and leadership or management development.

Responsibilities:

• Lead, mentor, and coordinate the activities of a team of 2–5 analysts, ensuring effective collaboration, task delegation, and professional development within the group.
• Oversee project management activities, including cost, schedule, and scope management, to ensure deliverables are met efficiently and on time.
• Facilitate regular team meetings and communicate project goals, progress, risks, and issues to both team members and stakeholders.
• Document and report on significant events, accomplishments, and team outputs on a weekly and monthly basis.
• Engage with stakeholders, facilitate ad hoc meetings, and represent the team in technical and business discussions.
• Serve as a primary subject matter expert for business process reengineering, organizational assessment, and process improvement initiatives within the project scope.
• Analyze complex problems and propose effective, evidence-based solutions, leveraging specialized methodologies and best practices.
• Provide expert guidance and insight to both the team and senior management on technical and functional issues, ensuring alignment with organizational objectives.
• Support the implementation, validation, and testing of new technical solutions (e.g., system releases, tool upgrades), coordinating requirements and user feedback for continuous improvement.
• Oversee the preparation and maintenance of documentation such as Standard Operating Procedures (SOPs), FAQs, training materials, and process workflows.
• Ensure the team provides timely Tier 1 and Tier 2 support, including identifying, documenting, triaging, and resolving technical inquiries from internal and external users.
• Coordinate with other service desks and subject matter experts to escalate and resolve complex issues efficiently.
• Monitor team and project performance, ensuring compliance with quality assurance standards and contract requirements.
• Develop and implement quality assurance measures, reviewing outputs and deliverables to ensure accuracy and consistency.
• Generate and analyze performance metrics to support decision-making and continuous improvement efforts.
• Oversee the development, delivery, and evaluation of training sessions for various stakeholder groups, ensuring materials are accurate and up to date.
• Facilitate knowledge transfer within the team and across the organization, maintaining comprehensive documentation and contributing to organizational knowledge bases.
• Support organizational change management initiatives, including communication planning and stakeholder engagement.
• Contribute to strategic planning, business model development, and performance management services as needed.

Require Experience:

• 10 years of related experience
• Demonstrated experience leading small teams
• Experience supporting electronic submission standards and processes
• Strong documentation skills
• Experience providing end-user support
• Experience with project management methodologies
• Excellent communication skills
• Proficiency with MS Office Suite

Preferred Experience:

• Experience with FDA or other government regulatory agency
• Project Management certifications
• Experience supporting organizational change management, strategic planning, or business model development
• Familiarity with FDA data standards and data exchange formats (e.g., CDISC, SEND, HL7, SPL)
• Prior work in a government contracting environment

Education & Training:

• BS/BA degree
• Prefer Masters/PhD in public health, health science, or related field

Salary Range:

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

• Lead, mentor, and coordinate the activities of a team of 2–5 analysts, ensuring effective collaboration, task delegation, and professional development within the group.
• Oversee project management activities, including cost, schedule, and scope management, to ensure deliverables are met efficiently and on time.
• Facilitate regular team meetings and communicate project goals, progress, risks, and issues to both team members and stakeholders.
• Document and report on significant events, accomplishments, and team outputs on a weekly and monthly basis.
• Engage with stakeholders, facilitate ad hoc meetings, and represent the team in technical and business discussions.
• Serve as a primary subject matter expert for business process reengineering, organizational assessment, and process improvement initiatives within the project scope.
• Analyze complex problems and propose effective, evidence-based solutions, leveraging specialized methodologies and best practices.
• Provide expert guidance and insight to both the team and senior management on technical and functional issues, ensuring alignment with organizational objectives.
• Support the implementation, validation, and testing of new technical solutions (e.g., system releases, tool upgrades), coordinating requirements and user feedback for continuous improvement.
• Oversee the preparation and maintenance of documentation such as Standard Operating Procedures (SOPs), FAQs, training materials, and process workflows.
• Ensure the team provides timely Tier 1 and Tier 2 support, including identifying, documenting, triaging, and resolving technical inquiries from internal and external users.
• Coordinate with other service desks and subject matter experts to escalate and resolve complex issues efficiently.
• Monitor team and project performance, ensuring compliance with quality assurance standards and contract requirements.
• Develop and implement quality assurance measures, reviewing outputs and deliverables to ensure accuracy and consistency.
• Generate and analyze performance metrics to support decision-making and continuous improvement efforts.
• Oversee the development, delivery, and evaluation of training sessions for various stakeholder groups, ensuring materials are accurate and up to date.
• Facilitate knowledge transfer within the team and across the organization, maintaining comprehensive documentation and contributing to organizational knowledge bases.
• Support organizational change management initiatives, including communication planning and stakeholder engagement.
• Contribute to strategic planning, business model development, and performance management services as needed