Project Manager

DRT Strategies, Inc.•Silver Spring, MD

1d•$90,000 - $120,000

About The Position

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: In accordance with Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines," the Food and Drug Administration (FDA) has established the PreCheck program. The objective of this program is to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of pharmaceutical manufacturing facilities within the United States. The program is designed to streamline the review of domestic pharmaceutical manufacturing processes and eliminate unnecessary regulatory burdens while maximizing the timeliness and predictability of such reviews. The Office of Pharmaceutical Quality (OPQ) requires the services of a full-time Project Manager to provide comprehensive program management support for the FDA PreCheck program. Job Summary: The Project Manager will be central to supporting the launch of this initiative under a very tight timeline, as well as supporting the development of new processes and procedures, and responsible for conducting the initial daily program management activities crucial for its effective launch. This project manager shall perform the following duties, including but not limited to: Execute day-to-day program management tasks essential for the successful operation of the PreCheck program. Provide direct support to the Deputy Director of Pharmaceutical Quality and other senior leadership staff as required. Lead the development and formalization of processes and standard operating procedures for the implementation and execution of the PreCheck program. Perform other duties as assigned related to the successful management of the program. Develop processes and procedures for initiation and deployment of the PreCheck program to an operating status.

Requirements

Must have or be able to obtain a Public Trust clearance
Have a minimum of 5 years of demonstrated experience and working knowledge of project management methodologies, and experience using these methodologies to implement projects within a federal government environment.
High level of professionalism, diplomacy, and patience
Ability to multitask efficiently and effectively
Ability to garner support and operate with political savvy
Ability to deal with ambiguity and frequent changes in priorities
Ability to manage multiple tasks and prioritize workload based on needs of the client
Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.

Nice To Haves

Previous experience with FDA mission, programs, policies, procedures, and communication activities preferred
PMP Preferred

Responsibilities

Lead day-to-day program management activities to support the successful execution of the PreCheck program.
Coordinate and manage program schedules, milestones, and deliverables across multiple concurrent initiatives.
Facilitate kickoff meetings, recurring project meetings, and ad hoc stakeholder sessions, including documenting and distributing meeting minutes.
Develop, implement, and continuously refine program processes, standard operating procedures (SOPs), and workflow documentation.
Provide direct program management support to senior leadership, including the Deputy Director of Pharmaceutical Quality, ensuring alignment with strategic priorities.
Monitor project performance, track progress against milestones, and proactively identify risks with recommended mitigation strategies.
Prepare and deliver comprehensive monthly status reports, including progress summaries, upcoming activities, risks, and cost/schedule variances.
Analyze program data and develop visualizations (e.g., dashboards, charts, reports) to support decision-making and performance tracking.
Engage and coordinate with cross-functional stakeholders across FDA, HHS, and other federal entities to ensure timely execution of program objectives.
Develop training materials and support onboarding of program personnel to ensure consistent adoption of processes and tools.
Deliver final program reports and respond to ad hoc requests for briefings, analyses, and executive-level communications as needed.