The University of Maryland, Baltimore (UMB) School of Pharmacy is seeking multiple contractualResearch Pharmacist to aid in facilitating outreach to entities that have nominated a bulk drug substance for inclusion on the 503b Bulks list. These nominators may include national medical/pharmacy organizations, chemical manufacturers, and/or special interest groups. The Research Pharmacist, in collaboration with the research team and the FDA, will identify information gaps in the submitted nomination and develop a prioritized list of specific information that will be collected from nominators to complete the nomination. The Research Pharmacist will assist with the testing and data entry of the information into a centralized database. In collaboration with the Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities research team, develop criteria to prioritize future evaluations of completed nominations.
Benefits for Contractual Employee: UMB offers a generous benefits package that includes 10 vacation days, 11 personal and holidays, 5 sick days; comprehensive health insurance and supplemental retirement options; and limited tuition remission for employees enrolled at UMB.
Review master list of nominations to identify information deficiencies and develop a prioritized list of information that needs to be collected in order to complete the nomination.
Engage nominators through various outreach efforts to collect the additional information deemed necessary.
Work with the database development team to test the system as well as enter collected information into the database.
In collaboration with the Clinical Use of Bulk Drug Substances nominated for use in compounding by outsourcing facilities research team, develop criteria to prioritize future evaluations of completed nominations.
Responsible for generating task and variable lists for programmers for the development of analysis files; collaborate with programmers and other staff involved in projects to accomplish project related objectives and goals.
Maintain established procedures concerning quality assurance in various areas, including data analysis, security of data, and documentation of work. Lead performance improvement processes related to data analysis and deliverables. Provide quality improvement.
Ensure compliance with all applicable University, governmental, and sponsor regulations, laws and policies related to the conduct of trials involving investigational or marketed drugs.
Manage required record-keeping, shipping, ordering, and inventory activities. May perform administrative duties, such as staff scheduling, supervision of pharmacy technicians, and coordination of drug utilization reporting or project coordination.
Performs other duties as assigned.
Education: Bachelors of Science in Pharmacy (BSPharm). PharmD from an ACPE accredited school/college of pharmacy preferred.
Preferred Experience: At least 3 years of experience as a Pharmacist, preferably in a compounding pharmacy or a pharmacy that performs compounding.
Licensure/Certification: Current pharmacist licensure in good standing that will be reciprocal with State of Maryland Board of Pharmacy, and/or the ability to secure and retain an active State of Maryland Pharmacist license for employment.
Other: No substitution of experience for minimum education requirement.
Knowledge, Skills, and Abilities:
Ability to maintain high standards with the work being performed and maintain awareness with trends and influences.
Excellent organizational, detail-oriented, and time management skills are required. Ability to manage multiple projects, work independently, set/re-evaluate priorities, meet deadlines and initiate follow-up action as necessary.
Knowledge of the regulatory landscape surrounding pharmaceutical compounding and a willingness to state up-to-date on changes.
Ability to work cooperatively with others and demonstrates professional, ethical, respectful, and courteous behavior when interacting with others.
Must communicate clearly and concisely both verbally and in writing.
Hiring Range: Commensurate with education and experience
If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday - Friday, 8:30am - 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
Job: Reg or CII Exempt Staff - E2507G
Employee Class Exempt Contingent II
Full Time/Part Time: Full-Time
Shift: Day Job
Organization: School of Pharmacy - Pharmacy Practice and Science
Job Posting: Sep 6, 2019
Unposting Date: Oct 7, 2019, 3:59:00 AM
Internal Number: 132681
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.