Programmatic Technical Advisor (Mid-Level)

About the Role

Culmen International is looking for a Programmatic Technical Advisor (Mid-Level) to support a HHS program in Washington, DC. This work will support the Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services and are important in helping BARDA in developing medical solutions in biotechnology and biopharmaceuticals. These services help BARDA respond to public health threats from chemicals, germs, radiation, nuclear events, pandemic flu, and new infectious diseases. BARDA works closely with developers, manufacturers, and government agencies like the FDA to move research forward, encourage new ideas, and coordinate with HHS, other government groups, and industry partners. BARDA’s work includes vaccines, treatments, tests, and products that are not medicines. The pandemic flu program increases vaccine production in the US and worldwide, particularly in developing countries. The CBRN division works with NIH, CDC, and industry to improve animal testing, product recipes, and lab testing. The Emerging Infectious Diseases program is also setting up ways to review and add new or returning diseases to BARDA’s work, including those that need EPA approval.

What You’ll Do in Your New Role

• Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.
• Provide advance services including but not limited to : Data cleaning; Data transfers; Data quality control; Data integration and validation; Data analysis and report package preparation; Statistical simulation; Statistical toolbox for advanced data modelling, tabulation, and visualization. In addition, this position will provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians.
• Directs tasks and leads technical efforts and scientific projects. Acts as an SME on scientific subjects. Contributes subject matter expertise to programs with technical or program management expertise. Facilitates meetings as directed.
• Provide advisory support to BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers / market research abstracts, technical proposals, and budget proposals.
• Participate on Program Coordination Teams (PCTs)
• Provide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed
• Participate in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Analyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed.
• Additional duties related to programmatic support for MCM maybe assigned

Required Qualifications

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Desired Qualifications

Extensive knowledge of FDA / ICH guidelines and CDISC data standards preferred.

About the Company

Culmen International is committed to enhancing international safety and security,strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.

To learn more about Culmen International, please visit www.culmen.com

At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.

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