Health Scientist III to work in collaboration with CDC NCEZID’s Regulatory Affairs staff and others involved in public health emergency preparedness and response activities.
Essential Duties and Responsibilities:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)
Provide clinical, epidemiologic, scientific, and technical expertise and guidance on pathophysiology of diseases and clinical conditions.
Develop protocols and regulatory documents/applications required for the deployment and clinical utilization.
Initiate, coordinate, develop, review, submit, and maintain various regulatory mechanisms.
Use Authorization (Pre-EUA)/EUA requests, and/or Emergency Use Instructions (EUI)) to facilitate safe and effective clinical use of MCMs.
Evaluate, initiate and manage protocol amendments, annual reports, safety reports, and correspondences with FDA for currently existing regulatory mechanisms.
Draft scientific and technical documents of such as but not limited to scientific and technical documents regarding utilization of CBRN medical products, clinical protocols and amendments, informed consents, study reports, standard operating procedures (SOPs), manuscripts, communication and training materials for the intended audience for a wide range of CBRN MCMs based on the relevant data and in in accordance with CDC policy or recommendations.
Knowledge, Skills and Abilities:
Provide expert scientific regulatory knowledge, guidance and consultation regarding drugs, biologics and/or devices with a special emphasis on bioterrorism-related and other public health emergency preparedness and response.
Contribute to medical countermeasures clinical guidance development that involves researching new and existing data on MCMs; systematic reviews and literature searches to support the development of evidence-based recommendations, including data abstraction and interpretation; designing a clinical guidance development algorithm for biological threats; and preparing and editing clinical guidance documents.
Chenega Corporation and family of companies is an EOE. Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity
Native preference under PL 93-638.
We participate in the E-Verify Employment Verification Program.
Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
Minimum of a Master’s Degree in disciplines such as science, nursing or pharmacy. Candidates with relevant professional licenses (i.e. RN) or certifications (i.e. RAPS) preferred. Minimum of six (6) years’ experience in clinical (outpatient and/or inpatient) settings. Prior CDC experience preferred.
FDA Regulatory experience
Public Health experience
Pharmacy experience and/or academia
Internal Number: 1800002526
About Chenega PS SBU
The Professional Services Strategic Business Unit (PS SBU) specializes in providing Information Technology, Health and Scientific, Engineering and Technical Support, Professional Management and Administrative Services to Federal Government Civilian Agencies. The PS SBU 8(a) companies include Chenega Government Consulting, LLC (CGC), Time Solutions, LLC (TSLLC) ,Chenega Professional and Technical Services, LLC (CPTS) and Chenega Enterprise Systems & Solutions, LLC (ChESS). The PS SBU provides each company shared support, including human resources, recruiting, contracting, marketing, administration, finance & accounting, business development, and security, allowing each company to focus on their customers in their day to day operations. Our dedication to providing quality support includes ITIL, PMBOK, CMMI Level 2, ISO 20000:2011 and ISO 9001:2008 certified processes. Our personnel provide a range of support to several different federal agencies including the Department of Energy (DOE), Department of Justice (DOJ), The Federal Bureau of Investigations(FBI), The Drug Enforcement Administration(DEA), The United States Agency for International Development(USAID), The National Security A...gency(NSA), Department of Homeland Security (DHS), the Department of Education (EDU), General Services Administration (GSA), the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC).