Company Job Title: Health Scientist III-CPTS Chenega Job Title: Research Associate VI Clearance: NACI Location: Atlanta, GA Reports To: Program Manager FLSA Status: Exempt, Full Time, Regular Prepared Date: 12-28-2018 Approved Date: 12-28-2018
Summary: Chenega Professional & Technical Services, LLC seeks a 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.
Non-Essential Duties: Other duties as assigned
Supervisory Responsibilities: # of individuals/position or NONE
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 Regulatory experience Public Health experience Pharmacy experience and/or academia
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.
Diversity: Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
Ethics: Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment. During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.
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.
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).