1. Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University. 2. Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed. 3. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 4. Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments. 5. Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies. 6. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 7. Manages and coordinates training sessions for assigned departments when new policies or practices are adopted. 8. Ensures compliance with University and federal regulations as they apply to the assigned departments. 9. Identifies, plans, and develops administrative policies for the assigned departments. 10. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 11. Assesses and makes recommendations regarding staff development and staffing levels. 12. Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis. 13. Manages a staff of exempt and non-exempt employees. 14. May perform other duties as assigned.
Preferred Education: BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.
Preferred Education, Experience and Skills: BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.
Posting Position Title: Manager 3
Required Skill/ability 3: Ability to motivate, develop, and assess learning capacity of direct reports.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Senior Regulatory Manager
Required Skill/ability 1: Ability to clearly communicate and understand written information.
Required Skill/ability 2: Ability to analyze ideas, use logic, and recognize the nature of issues to develop creative problem-solving opportunities.
Bachelor's Degree in related field and 5 years of experience or an equivalent combination of education and related experience.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.