The Role
Provide project and program management and technical support for FDA Controlled Substance initiatives. Plan and track projects, conduct research and document development, coordinate stakeholders and meetings, manage data and SharePoint repositories, prepare briefings and reports, and support day-to-day operations for the Divisions of Psychiatry and Anesthesia/Addiction Medicine.
Summary Generated by Built In
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.
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
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.
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.
- 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 required
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.
- $80,000 - $140,000
- Salary commensurate with experience.
Skills Required
- PharmD
- 5+ years of experience supporting the FDA and/or industry
- Ability to obtain and maintain a U.S. government Public Trust clearance; must be a U.S. citizen or lawful permanent resident
- PMP Certification
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The Company
What We Do
DRT Strategies, Inc. (DRT) is an award-winning technology innovator and leading digital transformation partner to large federal agencies and commercial clients for nearly 20 years. The company is a ServiceNow™ Partner - Specialist, Amazon Web Services (AWS) Consulting Partner, UiPath Partner, SAFe Bronze Partner, Esri Bronze Partner, and holds ISO 9001:2015, ISO/IEC 20000-1:2018, and ISO/IEC 27001:2013 certifications and has achieved CMMI-DEV Level 3. DRT is headquartered in Arlington, Virginia, with offices in Atlanta, Georgia. More information on the company can be found at www.drtstrategies.com.
