Overview

Description:

Spatial Front provides IT solutions to federal, state, and local governments, and the private sector.

The Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) requires business operations, project management and business analysis support for various Division of Information Technology Management Staff (DITM)/Office of Information Management and Technology (OIMT) managed projects and operational activities. The IT Project Management team shall provide Business Process and Analysis, IT Project Management, and Strategic Planning support for the Scientific Innovation and Infrastructure Branch.

 

Project Overview:

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), is seeking services to provide task management support to assist with the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) implementation activities and other activities in CDER’s controlled substances portfolios. FDA has established work groups to support the implementation of controlled substances policy programs and initiatives. The work groups are developing project plans outlining deliverables and timelines. Activities include holding public meetings, issuing guidance, and seeking public input via stakeholder engagement and public comment.

The Office of the Center Director requires services to provide task management support for the implementation of SUPPORT Act provisions and other activities in OCD’s controlled substances portfolios. Work from this order may also expand beyond controlled substances (such as unscheduled drugs) to other high-priority drug safety projects, including but not limited to critical safety initiatives and cross-cutting CDER safety programs

 

Primary Responsibilities:

Serves as a senior advisor to customer’s executive management team in a variety of capacities.
Government experience preferred – working with FDA a plus.
Responsible for identifying any potential program risks and for identifying them to the Government as soon as they are recognized.
Responsible for ensuring deliverables are done correctly and delivered on time.
Plans, supports, and provides advise/contributions in complex and critical efforts which include specific functional, technical, professional, or policy areas of the project.
Scope, map, and define project phases, deliverables, key milestones, and evaluation criteria.
Perform literature reviews/scans and data analysis.
Write, edit, and manage clearance for documents.
Design and implement digital solutions to track and document projects and workflows.
Design, implement, and maintain a database or data repository as needed.
Perform searches in FDA archival systems; identify, curate, and organize documents as needed.
Participate in the preparation and development of applicable notes and articles for sources such as the Federal Register, media releases, speeches, and other presentations delivered by FDA personnel.
Provide support for public meetings (support development of meeting strategy, draft Federal Register notes, book conference centers, invite and coordinate speakers, and provide onsite assistance).
Provide meeting support.
Track and follow up on project assignments and actions, and monitor timeliness of all FDA commitments and deliverables to assist with staff accountability.
Set up technology interface and logistics for FDA meetings and any stakeholder outreach meetings (Zoom, MS Teams, phone, etc.).
Respond to staff inquiries and requests in a timely manner.
Provide a monthly status report on all active tasks.
Must have demonstrated experience working on complex projects and portfolios that include cross-team and cross-functional responsibilities.
Experience with drug labeling updates and regulatory program management.
Experience with FDA’s Office of New Drugs (OND), particularly the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) and/or Division of Psychiatry (DP).
Controlled substances background desired, including knowledge of Controlled Substances Act.
Key responsibilities include:
– Providing advice and expertise.

– Outsourcing methods.

– Conducting value chain analysis.

– Strategic planning and process improvement methods.

– Change enablement and management.

– Consolidation of operations.
Requirements
Experience Required:

Minimum eight-ten years of experience is required.
Ability to pass a US Public Trust background investigation for access to the client site and computing systems.
Education/Experience:

Minimum level of education required: masters
PharmD, PhD, or MD desired
If master’s (MPH, MSN, etc.) or other higher level of educational achievement, demonstrated experience as well as other certifications (PMP, etc.) required.

 

Additional Information:

In order to meet the clearance requirements for this opportunity, candidates must be a Green Card Holder or US Citizen
Ability to pass a US Public Trust background investigation for access to the client site and computing systems. You must have lived in the US for the past three (3) years.
All candidates will be subject to a complete background check to include, but not limited to Criminal History, Education Verification, Professional Certification Verification, Verification of Previous Employment and Credit History.
About the Company:

SFI is nationally recognized by Inc. Magazine by being awarded the Inc. 5000 Award in 2018, 2019, and 2020. We pride ourselves on being one of the premier employers in the VA, MD, DC area.

Our commitment to excellence in client services and product development means that our people are attentive, hands-on, and bring industry-leading expertise that will meet and exceed your needs in a timely and cost-effective manner.

Every employee at SFI is a leader. We don’t settle. We motivate others to reach their full potential. To learn more about us visit: www.spatialfront.com

Other Information:

The salary range for this position is $14,000 – $190,000 annually.
This is a full-time in person position. Please no agencies, third parties, or corp-to-corp.
Equal-opportunity Employer, EOE AA M/F/Vet/Disability.
Spatial Front Inc. participates in E-Verify.