Qureos Mentor

Global Systems Engineering

<div>Description 


Global Systems Engineering (GSE), an Intreped Partners Company, is a HUBZone small business that supports the federal government with a variety of high-end technical and engineering services. We are responsive to our customers&rsquo; needs, which often change. This creates a fast-paced environment where priorities shift, and tasks may require short deadlines. GSE is seeking Sr. Scientific Technical Advisors, contingent upon contract award, to be performed hybrid onsite in Washington, DC. 
Candidate MUST:

Be a U.S. citizen or a Green Card Holder with the ability to obtain a Public Trust Clearance

Be located w/in 50 miles of the location for hybrid/onsite work. 


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


Required Qualifications: 

<ul>
<li>Minimum of Twelve (12) years of relevant experience with a
 
doctoral degree in biological and/or chemical sciences with relevant postdoctoral experience.</li>
</ul>
Or
<ul>
<li>Clinical studies: application of doctoral degree(s) in medicine or pharmacy or with commensurate experience(s) advanced degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research, including seven (7) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred. PhD in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Masters or Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)</li>
</ul>
Or

Relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions, application of degree in biology, chemistry, or pharmacy with commensurate experience.

Or

A bachelor's degree in chemistry, Engineering or Biology including ten (10) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management. 


Or equivalent*

Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of five years (260 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).</div>

Sr. Scientific Technical Advisors (Contingent)

<div>Description 


Global Systems Engineering (GSE), an Intreped Partners Company, is a HUBZone small business that supports the federal government with a variety of high-end technical and engineering services. We are responsive to our customers&rsquo; needs, which often change. This creates a fast-paced environment where priorities shift, and tasks may require short deadlines. GSE is seeking Scientific Technical Advisors, contingent upon contract award, to be performed in a hybrid onsite setting in Washington, DC. 
Candidate MUST:

Be a US. Citizen or a Green Card Holder with the ability to obtain a Public Trust Clearance

Be located w/in 50 miles of the location for hybrid/onsite work. 


Key Responsibilities: 
<ul>
<li>
Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.</li>
<li>Provide advanced 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</li>
<li>In addition, this position will provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians.</li>
<li>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.</li>
<li>Provide advisory support to BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS IGCE &amp; Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].</li>
<li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li>
<li>Participate in Program Coordination Teams (PCTs)</li>
<li>Provide assessments, recommendations, and guidance, as well as educational material to PCT and COR, as needed.</li>
<li>Participate in strategic discussions with the USG to build new program areas in alignment with BARDA&rsquo;s mission space.</li>
<li>Provide recommendations for project development, level portfolio management, and oversight as required.</li>
<li>Provide recommendations or advice on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li>
<li>Analyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed.</li>
<li>Additional duties related to programmatic support for MCM may be assigned.</li></ul> 


Required Qualifications: 


Minimum of five (5) years of relevant industry experience with a Bachelor&rsquo;s degree (preferred) in biological and/or chemical sciences and/or relevant experience. 


Or

Postgraduate degree(s) in medicine or pharmacy, or with commensurate experience , bachelor's degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research, including three (3) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred. Bachelor's degree (graduate preferred) in an appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or

Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar) 


Or

Relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions, application of degree in biology, chemistry, or pharmacy with commensurate experience.

Or

A bachelor's degree in chemistry, Engineering or Biology including five (5) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management. 


Or equivalent*

Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of five years (52 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).</div>

Scientific Technical Advisors (Contingent)

<div>Description 


Global Systems Engineering (GSE), an Intreped Partners Company, is a HUBZone small business that supports the federal government with a variety of high-end technical and engineering services. We are responsive to our customers&rsquo; needs, which often change. This creates a fast-paced environment where priorities shift, and tasks may require short deadlines. GSE is seeking a Program Manager, contingent upon contract award, to be performed in a hybrid onsite setting in Washington, DC. 
Candidate MUST:

Be a U.S. citizen or a Green Card Holder with the ability to obtain a Public Trust Clearance

Be located w/in 50 miles of the location for hybrid/onsite work. 


Key Responsibilities: 
<ul>
<li>
Oversee all technical and functional activities necessary for the successful management of this SOW.</li>
<li>Management of all performance under this, and all subsequent task orders at all levels.</li>
<li> Management of all staff (recruitment, retention, On and Off&#8208; boarding, performance etc.) hired in both Onsite and Offsite capacity under this contract.</li>
<li>Management of all Consulting ODC hires directed by USG Track and account for all Government Furnished Equipment (GFE).</li>
<li>Provide leadership and guidance to Contractor staff hired to support BARDA. This includes appropriate training on working with the USG, BARDA its processes and Program/contract management.</li>
<li>Ensure the Contractor is compliant with all requirements of this SOW.</li>
<li>Advise the COR on any means to improve operational and performance efficiency. Coordinate routine meetings with Contractor staff to address ongoing performance.</li>
<li>Identify and report any Contractor performance issues to the COR and CO/CS in timely manner any Contractor performance issues to the COR and CO/CS.</li>
<li>Ensure quality control of all services and deliverables provided under this SOW.</li>
<li>Partner with the Travel Manager to ensure all travel meets all requirements of this SOW.</li>
<li>Work with Contractor&rsquo;s budget office to ensure all invoices are submitted accurately and timely.</li>
<li>Management of all travel requested by USG or Contractor staff.</li>
<li>Provide routine training and guidance to all Contractor staff on the rules and procedures when traveling on behalf of USG.</li></ul> 


Required Qualifications:
<ul>
<li>Bachelor&rsquo;s Degree or higher / in Project/Program management, Business Management, Public Administration or related fields is a must.</li>
<li>A minimum of 10 years of relevant experience in managing Federal contracts of a similar type, scale, and scope.</li>
<li>Experience with Personnel management supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).</li>
<li>Experience with performance assessment and corrective measures, as well as risk management, mitigation, and quality control.</li>
<li>A project management approach, in keeping with Federal and industry best practices, is developed, implemented, and maintained for planning, organizing, managing, documenting, and closing out all task orders awarded throughout the life of this requirement.</li>
<li>Process all travel requests promptly and efficiently in accordance with the terms of this contract, as well as ASPR and BARDA travel procedures.</li>
<li>Track all travel at all levels for reporting. Make every effort to maximize cost savings for all travel executed on behalf of USG.</li></ul></div>

Program Manager (Contingent)

Join Global Systems Engineering and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Global Systems Engineering

ABOUT_COMPANY

Sr. Scientific Technical Advisors (Contingent)

Scientific Technical Advisors (Contingent)

Program Manager (Contingent)