Senior Functional Specialist

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

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, andfinancial 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 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:

• PMP Certification

Education & Training:

• PharmD required

DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.

Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing [e-mail], or by dialing 571-482-2517.

For additional information, please review Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).

Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at [e-mail] if you believe you have received a fraudulent email.