FDA Office of Compliance (OC) - Strategic Implementation

PRESOLICITATION NOTICE ONLY.  THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS

THE ANTICIPATED AWARD IS A 1-YEAR HUBZONE SET-ASIDE

The Office of Compliance requires support in the following areas to enable effective execution of cross-office compliance priorities. These priorities reflect the administration's emphasis on speed, coordination, accountability, and consistent execution of regulatory priorities, specifically, Executive Order 14017 (America’s Supply Chains), Executive Order 14110 (Safe, Secure, and Trustworthy AI), and the Executive Orders for Regulatory Relief for Domestic Pharmaceutical Manufacturing (May 2025) and Ensuring Lawful Governance (Feb 2025).

Independently, and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, facilities and otherwise do all the things necessary for, or incidentally, the performance of the work described below.

Task: Strategic Implementation and Leadership Coordination Support

The contractor shall provide the following services to support Office of Compliance leadership execution of cross office compliance priorities:

Area 1- Leadership Coordination and Decision Support: The contractor shall provide services that will enable CDER OC to provide a framework for structured support for cross-office leadership engagement, ensuring that decision-relevant information is synthesized, surfaced, and acted upon in a timely manner. By facilitating communication across senior leaders and translating complex, multi-office inputs into clear decision frameworks, this work enables CDER compliance leadership to respond with speed and coherence to rapidly evolving priorities.

Area 2- Enterprise Alignment: The Contractor shall provide support by facilitating structured communication mechanisms, developing shared reference materials, for CDER OC management to identify and resolve inconsistencies in how compliance initiatives are being interpreted or applied across offices. This includes monitoring implementation activities across component offices, flagging divergences early, and leadership providing communication in issuing clarifying guidance where needed. The goal is to ensure that CDER Compliance speaks and acts with one voice on compliance matters, regardless of which office is at the point of execution- thus reducing the risk of fragmented or conflicting execution that could undermine CDER Compliance’s ability to meet its commitments.

Area 3-Milestone Tracking: The volume and velocity of high-visibility compliance initiatives currently facing CDER — driven by Presidential Executive Orders, HHS directives, and internal FDA priorities — demand a disciplined, centralized approach to tracking deliverables, deadlines, and interdependencies across component offices. The Vendor shall provide a framework that ensures that milestone tracking is not just a reporting exercise but a genuine organizational capability — one that is embedded in leadership practice, supported by clear accountability, and resilient enough to keep pace with CDER's evolving compliance demands. The vendor shall support the office in its assessment of how work flows across OMQ, OCQC, OUDLC, ODSIR, OSI, and OPRO to design a tracking framework that reflects how the organization operates. This may include identifying where accountability is unclear, where handoffs between offices create delays, and where existing processes need to be redesigned to support reliable milestone execution.

Area 4- Strategic Implementation Planning: the contractor shall support execution planning for Presidential, HHS, FDA, and CDER compliance priorities. This includes supporting OC’s efforts to efficiently utilize resources, processes, and systems to achieve outcomes that advance FDA’s mission. Deliverables include but not limited to: Conducting assessments of the existing strategic and operational plans, procedures, and  practices to document and/or define the business processes; develop baseline measurements to assess the effectiveness of existing FDA strategic plans; Assisting with the prioritization of critical output, productivity, and outcome measures; Developing implementation roadmaps and performance measures to track effectiveness.

Contractor Personnel

The contractor shall identify and hire staff in the following labor category: Senior Organizational Development Consultant/Executive Leadership Coach with documented experience demonstrating requisite expertise in federal regulatory environments, executive level coordination, and strategic implementation support.

Key Personnel / Staffing

The individual in the following labor category is considered essential Key Personnel.

• Senior Organizational Development Consultant/Executive leadership Coach (1)

Therefore, pursuant to HHSAR clause 352.237-75, Key Personnel, this individual will be considered ‘Key Personnel’.

• The Contractor shall ensure that all Contractor support personnel are onboard and ready to work, no later than three weeks after the contract award date.
• All Contractor staff must be cleared through FDA security before they may begin billable work on this contract.  

Key Personnel Position Description

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to this contract.  

The FDA considers the selection of this individual to work on this task as critical to the success of the program.  The individual as a subject matter expert must have demonstrated experience in the work areas described herein and in the individual task statements of work as they are provided. The Subject matter expert will be reviewed for acceptability by the FDA before proceeding with any contract tasks.

The Contractor shall submit new or replacement personnel resumes to the COR and Project Lead(s) for review. The FDA requires a 30-day notice for the replacement of key personnel. The COR will verify that the new personnel meet the requirements of the proposed Labor Category and SOW before the candidate starts the FDA on-boarding process. FDA has the right to request a change in key personnel based upon non-performance.

Senior Organizational Development Consultant/Executive Leadership Coach (1)  

The Senior Organizational Development Consultant labor category in this contract is considered essential. This person will provide strategic implementation and leadership coordination support for the Office of Compliance cross-office compliance initiatives. Proposals with key personnel that demonstrate this familiarity through specific, verifiable experience will be evaluated more favorably than those with only general federal government exposureThe individual shall have the following qualifications:

Educational Background: Possession of a minimum master's degree in organizational development, public administration, industrial-organizational psychology, business administration, human-systems integration, or a closely related field. Degrees with coursework or research in cognitive/behavioral neuroscience, human factors, or organizational neuroscience will be viewed favorably and should be clearly identified.

Applied Neuroscience Expertise: Demonstrated, verifiable application of neuroscience or behavioral science principles to organizational strategy, change management, or leadership support in complex institutional settings. This may be evidenced through:

• Published research, white papers, or presentations
• Case studies demonstrating neuroscience-informed interventions in organizational contexts
• Formal training, credentials, or certifications in applied neuroscience, neuro-leadership, or behavioral science

Organizational Development and Strategic Implementation Experience:  At least 10 years of demonstrated experience in management consulting, organizational development, or strategic implementation support, with at least 5 years at a senior level. Experience must include:

• Enterprise-level program coordination across multiple organizational units
• Execution planning and milestone management for high-visibility, multi-stakeholder initiatives
• Facilitating leadership decision-making and synthesizing complex information for senior executives
• Verifiable experience facilitating executive-level decision-making, coordinating cross-functional initiatives, and supporting leadership execution of strategic priorities.
• Expertise in implementation planning, milestone tracking, program coordination, and execution management for complex, multi-stakeholder initiatives.
• Demonstrated ability to coordinate activities across multiple organizational units, facilitate alignment, and support unified execution of strategic objectives.

FDA / Federal Regulatory Environment Familiarity: Direct experience supporting FDA, CDER, or comparable federal regulatory agencies (or demonstrated familiarity with FDA's operational structure, compliance functions, and regulatory frameworks (FD&C Act, DSCSA, GDUFA, etc.)) is strongly desired and will elevate an offeror's rating. Experience with compliance, enforcement, or regulatory oversight functions is particularly relevant.

Professional Certifications: At least one recognized professional certification relevant to the scope of work, such as a Project Management Professional (PMP), Certified Management Consultant (CMC), NeuroLeadership Institute certification or equivalent applied neuroscience credential, Organizational Development certifications (e.g., ODCP, RODC), Other equivalent credentials demonstrating professional standing in strategic implementation or OD.

Place of Performance:

Work will be performed primarily at the contractor’s site. Unless otherwise specified, all meetings (excluding preparatory meetings) between the contractor and FDA staff will be held at FDA’s White Oak Headquarters building, located at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

Anticipated Period of Performance: 

12 months begining in fiscal year 2026.