MINIMUM QUALIFICATIONS:
JOB SUMMARY
Function: The Regulatory Scientist II will be assigned as a Study Director, as defined by the U.S. FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point of study control with overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. The Regulatory Scientist II works in conjunction with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies to design and execute regulated nonclinical studies compliant with the U.S. FDA GLP regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory Scientist II may also function as a Principal Investigator for extramurally funded research programs and be expected to manage complex programs with multiple studies.
ESSENTIAL JOB FUNCTIONS:
KNOWLEDGE/SKILLS/ABILITIES
SUPERVISION
Received: Scientific Director, ORNcS
Given: May be responsible for direct supervision of and will provide oversight for Regulatory Scientists, Research Scientists, Research Associates, Research Technicians working with the ORNcS. Will provide oversight for veterinary technicians and other research staff involved in conduct of regulated studies.
BUDGET RESPONSIBILITY
Direct: Will be responsible for fiscal oversight of extramurally funded projects for which they serve as Principal Investigator.
Indirect: May assist the ORNcS Scientific Director with institutional budget planning.
DECISION-MAKING RESPONSIBILITY
WORKING ENVIRONMENT/EQUIPMENT
OTHER:
Must be able to meet the medical and/or vaccination requirements for work in biocontainment facilities and with Tier 1 select agents.
Individuals holding this title will also be required to hold a secondary non-tenure track faculty appointment in a UTMB basic sciences department and will participate in annual appointments/promotion/tenure reviews with that department.
SALARY:
Commensurate with experience
Official Regulatory Statement for Healthcare jobs’ Job Descriptions: May be exposed to such occupational hazards as communicable diseases, blood borne pathogens, ionizing & non-ionizing radiation, hazardous medications and disoriented or combative patients or others.
Equal Employment Opportunity
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
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