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SENIOR REGULATORY COMPLIANCE CONSULTANT
Job Title: SENIOR REGULATORY COMPLIANCE CONSULTANT
Job Code: 2861
FLSA: E
Job Level: 16
Revised Date: 12/01/2007
Job Family: JF 28
Occupational Summary
PROVIDE GOOD CLINICAL PRACTICES REGULATORY COMPLIANCE EXPERTISE TO THE DUKE CLINICAL RESEARCH UNITS. DIRECT A VARIETY OF ACTIVITIES FOR THE QUALITY ASSURANCE AND REGULATORY COMPLIANCE GROUP. IMPLEMENT QA/ COMPLIANCE STRATEGY TO ENSURE COMPLIANCE WITH ALL APPLICABLE REGULATORY REQUIREMENTS AND MAKE RECOMMENDATIONS REGARDING THE SPECIFIC ACTIVITIES AND RESOURCES REQUIRED TO SUPPORT THIS STRATEGY. CONDUCT INTERNAL AND EXTERNAL GxP AUDITS AND TRAIN STAFF ON PROPER CONDUCT OF AUDITS.B.S. DEGREE IN A SCIENTIFIC DISCIPLINE, PREFER ADVANCED DEGREE, MIN 8 YRS EXP IN THE PHARMACEUTICAL, MEDICAL DEVICE, BIOTECH, OR CONTRACT RESEARCH INDUSTRY, INCL. MIN. 4 YRS. EXP IN QUALITY ASSURANCE/REGULATORY AFFAIRS.
Work Performed
Required Qualifications at this Level
Education/Training
Experience
Skills
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
