FDA Program Manager — Health Policy & Research

DRT Strategies, Inc; Silver Spring (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

DRT Strategies, Inc. is seeking a seasoned Project/Program Manager to support the FDA's Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine.

You will lead project planning, tracking, and coordination across multiple initiatives, ensuring timely deliverables and clear leadership briefings. Responsibilities include literature reviews, data analyses, document development, stakeholder outreach, meeting coordination, and knowledge management.

Qualifications

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

Responsibilities

• 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

Education

PharmD

Job description

DRT Strategies, Inc. is seeking a seasoned Project/Program Manager to support the FDA's Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine.

You will lead project planning, tracking, and coordination across multiple initiatives, ensuring timely deliverables and clear leadership briefings. Responsibilities include literature reviews, data analyses, document development, stakeholder outreach, meeting coordination, and knowledge management.