Senior Functional Specialist

DRT Strategies, Inc.•Silver Spring, MD

3d•$80,000 - $140,000

About The Position

DRT Strategies is seeking a Senior Functional Specialist to provide project and program management initiatives and technical support to the FDA’s Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine. The role supports the FDA Controlled Substance Program team and Controlled Substances Initiatives, coordinating and managing work across controlled substances initiatives and programs, including high-priority activities related to substance use and overdose prevention. The position combines project planning and monitoring, research and analysis, document development, stakeholder and meeting coordination, data and knowledge management, and operational support. The specialist will help coordinate project teams, track commitments and deliverables, develop written products and briefing materials, support meetings and workshops, maintain project systems and records, and provide timely assistance for high-priority, time-sensitive initiatives. Candidates must have a PharmD and at least five years of experience supporting the FDA and/or industry. PMP certification is preferred. The 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. The stated salary range is $80,000–$140,000, commensurate with experience.

Requirements

At least 5 years of experience supporting the FDA and/or industry.
PharmD required.
Ability to obtain and maintain a U.S. government Public Trust clearance.
Must be a U.S. citizen or lawful permanent resident (green card holder) due to contract requirements.

Nice To Haves

PMP Certification

Responsibilities

Define project scope, phases, deliverables, milestones, timelines, and measures of success.
Develop and maintain project plans, trackers, schedules, and supporting 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 updates on project progress, accomplishments, risks, and upcoming activities.
Conduct literature reviews, environmental scans, and data analyses to support initiatives.
Retrieve, review, curate, and organize records from FDA systems and other relevant sources.
Contribute to 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 development of stakeholder engagement and outreach strategies.
Coordinate internal and external meetings, including participant outreach, agendas, briefing materials, logistics, and follow-up.
Document 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.