Project Description: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.
Job Summary: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.
Responsibilities:Project Planning and Management- 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.
Research, Analysis, and Document Development- 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.
Stakeholder and Meeting Coordination- 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
Data, Systems, and Knowledge Management- 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.
Team and Operational Support- 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
Required Experience:- 5+ years of experience supporting the FDA and/or industry
Preferred Experience:Education & Training:Work Authorization, Clearance Requirement, & Additional Information:- This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
- No agencies, third parties, or Corp-to-Corp submissions.
Salary Range:- $80,000 - $140,000
- Salary commensurate with experience.
