Job Listings

School of Health Professions - Biotechnology Regulatory Affairs Specialist - Department of Clinical and Diagnostic Sciences - F1604P

Company:
University of Alabama at Birmingham
Job Location:
Birmingham, Alabama
Category:
Physicians
School/College: School of Health Professions

Assignment Category
Full-Time

Rank: Assistant/Associate Professor

Tenure Status: Open Tenure

Payroll Status: Faculty 12

Job Description

The University of Alabama at Birmingham (UAB) is accepting applications for a full-time, twelve-month faculty position in the Biotechnology Program (BT), Department of Clinical and Diagnostic Sciences, School of Health Professions (SHP). This position is responsible for the development and delivery of a biomedically-focused online Graduate Certificate in Regulatory Affairs. Primary responsibilities include didactic instruction, scholarly activity, community service, student advising, and oversight of program operations.  

The Biotechnology Program has an excellent relationship with the UAB medical school and surrounding medical community. UAB is currently ranked as one of the premier medical schools and research institutions in the country. SHP is one of our nation's largest and most diverse schools of its type with more than twenty programs at the baccalaureate, masters, and doctoral levels. 
Minimum requirements include an MS degree (doctorate preferred) from an accredited institution and seven years of regulatory affairs experience. Experience in the Regulatory Affairs field could include expertise in: 1) Investigational Product Development, the FDA, and Good Clinical Practice Guidelines; 2) the roles and responsibilities of the Clinical Research Team and the Principal Investigator; 3) site selection and budget negotiations; 4) clinical study protocol elements and statistical considerations; 5) institutional review boards and consent of human volunteers and HIPAA regulations; 6) study monitoring and site management and study initiation visits; 7) safety reporting, accountability for the test article and trial terminal visits; and, 8) regulatory compliance and quality assurance. 
Salary, academic rank, and tenure status will be commensurate with qualifications and experience. Fringe benefits are provided that include a retirement plan and health care benefits.

Required Qualifications

MS degree from an accredited institution and seven years of regulatory affairs experience. 
Excellent regulatory writing skills required and will be reviewed.

Preferred Qualifications

Doctorate preferred from an accredited institution and seven years of regulatory affairs experience. Experience in the Regulatory Affairs field could include expertise in: 1) Investigational Product Development, the FDA, and Good Clinical Practice Guidelines; 2) the roles and responsibilities of the Clinical Research Team and the Principal Investigator; 3) site selection and budget negotiations; 4) clinical study protocol elements and statistical considerations; 5) institutional review boards and consent of human volunteers and HIPAA regulations; 6) study monitoring and site management and study initiation visits; 7) safety reporting, accountability for the test article and trial terminal visits; and, 8) regulatory compliance and quality assurance.

Open Date: 07/13/2021

Open Until Filled: Yes

EEO Statement

UAB is an Equal Opportunity/Affirmative Action Employer committed to fostering a diverse, equitable and family-friendly environment in which all faculty and staff can excel and achieve work/life balance irrespective of, race, national origin, age, genetic or family medical history, gender, faith, gender identity and expression as well as sexual orientation. UAB also encourages applications from individuals with disabilities and veterans.

Pre-employment Background Check

A pre-employment background check investigation is performed on candidates selected for employment.

About University of Alabama at Birmingham

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