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Project Manager 1 - FDA Office of Policy Initiatives and Projects (OPIP)

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CFD Research is seeking an individual that will work with the U.S. Food and Drug Administration (FDA) as a Project Manager 1 in the Office of Policy Initiatives and Projects (OPIP). The Project Manager will oversee project lifecycles, assist the FDA Program Manager in planning activities, coordinate meeting logistics, and serve as a liaison between FSMA-related workgroups and operational offices. The role involves managing complex projects, ensuring objectives are met within the prescribed timelines and budget constraints, and supporting FDA senior leadership on strategic initiatives related to the Food Safety Modernization Act (FSMA) and New Era of Smarter Food Safety.

Key Responsibilities:
1. Project Management and Coordination
o Manage the full lifecycle of projects from initiation to completion, ensuring objectives are met within set timeframes and funding parameters.
o Assist the FDA Program Manager with project planning activities, including information gathering, developing project plans, timelines, setting milestones, and determining required resources.
o Oversee project milestones and coordinate with team members to maintain progress toward project goals.
2. Meeting Support and Logistics
o Provide comprehensive support for meetings, ranging from small workgroup sessions to large-scale events like the Triannual Mid-year meeting, FSMA steering committee meetings, the FSVP two-day "go away" retreat, and other FSMA-related planning and implementation meetings.
o Develop meeting minutes, routine reports, and notifications for project team leaders and members.
o Schedule and coordinate meetings, handle logistical details, and facilitate follow-up actions as needed.
3. Project Planning and Reporting
o Update the FSVP Integrated Master Schedule (IMS), coordinating revisions and updates with various project leads to maintain an integrated plan.
o Track progress, identify risks, and document issues for resolution.
o Prepare monthly status reports, track issues and risks, and support the clearance of regulations and guidance documents through the agency clearance process.
o Serve as a liaison between upper management FSMA/New Era of Smarter Food Safety workgroups and operational offices, facilitating the hand-off of projects and addressing further needs.
4. Data Management and Evaluation
o Capture, evaluate, interpret, and analyze data to assess FDA's progress in meeting strategic goals and harmonizing efforts.
o Manage and review intra- and inter-agency tasks for FDA senior leadership, as well as center cross-cutting tasks.
o Conduct internal reviews to evaluate processes, identify risks, and resolve any open issues.
o Manage strategic outcomes and advise senior leadership on potential opportunities and impacts.
5. SharePoint and Document Management
o Design and maintain SharePoint sites based on stakeholder requirements.
o Manage SharePoint sites, including setting up user accounts, disabling access for departing employees, and adjusting account privileges.
o Review and utilize existing status report formats where applicable, ensuring that all communications are documented in detail.

Basic Qualifications:

u2022 Bachelor's degree in Project Management, Business Administration, Public Health, or a related field.
u2022 Familiarity with project management software and tools (e.g., MS Project, Asana, Trello).
u2022 Experience in managing SharePoint sites, including user account administration.
u2022 Strong organizational and multitasking skills, with the ability to manage multiple projects simultaneously.
u2022 Excellent communication skills, both written and verbal, with experience in preparing reports, documenting progress, and providing updates.
u2022 Proven ability to work collaboratively with diverse teams and stakeholders.

Desired Qualifications:

u2022 Project Management Professional (PMP) certification or equivalent.
u2022 Experience in the healthcare or food safety sectors.
u2022 Familiarity with the Food Safety Modernization Act (FSMA) and related regulations.
u2022 Knowledge of Federal Register submission and clearance processes.
u2022 2 years of project management experience, preferably in a governmental or regulatory environment.

Location: This role is based in the Huntsville AL area, and is 100% remote.

About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace & Defense, Biomedical & Life Sciences, Intelligence & Sensing, and Energy & Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for three of last four years. Learn more at ;br>
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers a highly competitive insurance package, including medical, vision, and dental insurance. We offer company paid leave, compensation time, parental leave, long-term disability, accidental death and dismemberment, and life insurance. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.

CFD Research is an EO employer - Veterans/Disabled and other protected categories
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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