Senior Functional Specialist

Overview

DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, 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.

The FDA Controlled Substance Program (CSP) team is seeking high-level task management support services to assist with high-priority activities, including those related to substance use and overdose prevention. In working with the Controlled Substances Initiatives (CSI) , we will provide program management support to coordinate and manage work efforts across controlled substances initiatives and programs, as well as dedicated support for OND’s Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine.

Provide Project and Program Management initiatives as well as technical support to the FDA's Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine.

• Define project scope, phases, deliverables, milestones, timelines, and measures of success.
• Develop and maintain project plans, trackers, schedules, and support documentation.
• Monitor assignments, action items, dependencies, and deadlines across active projects.
• Identify emerging issues and coordinate follow-up to support timely completion of FDA commitments.
• Compile monthly status updates on project progress, accomplishments, risks, and upcoming activities.

• Conduct literature reviews, environmental scans, and data analyses to support ongoing initiatives.
• Retrieve, review, curate, and organize records from FDA systems and other relevant sources.
• Contribute to the development of Federal Register notices, presentations, speeches, articles, reports, and related communications.
• Draft, revise, format, route, and track documents through internal review and clearance.
• Prepare briefing materials, summaries, and other written products for leadership and project teams.

• Support the development of stakeholder engagement and outreach strategies.
• Coordinate internal and external meetings, including participant outreach, agendas, briefing materials, logistics, and follow-up.
• Document key discussion points, decisions, recommendations, and next steps.
• Support public meetings and workshops through notice development, speaker coordination, registration, logistics, and on-site or virtual assistance.
• Arrange meeting platforms and technology for FDA and stakeholder engagements

• Develop and maintain digital tools, trackers, and workflows for monitoring projects and deliverables.
• Build and manage databases or data repositories needed to support project activities.
• Maintain SharePoint sites, project files, reference materials, and final records.
• Organize and archive meeting summaries, cleared documents, and supporting materials.
• Improve project processes and tools to strengthen coordination, reporting, and information management.

• Respond to staff inquiries and project-related requests in a timely manner.
• Coordinate across project teams to gather updates, resolve information gaps, and support completion of deliverables.
• Provide day-to-day operational support for high-priority and time-sensitive initiatives

• 5+ years of experience supporting the FDA and/or industry

• PMP Certification

• PharmD…