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Regulatory And Compliance Specialist
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Job Description
Job Summary
Involves the review and evaluation of healthcare regulatory compliance controls and programs, including diversion prevention and new pharmacy construction. Develops regulatory policies and systems from a strategic perspective; keeps abreast of regulatory issues, plans for changes and / or integration as new healthcare affiliations are assumed. Provides education and consultation to hospital and medical staff regarding the integration of compliance regulatory standards with programs and operations. Acts as a channel of communication to direct compliance issues to appropriate resources for investigation and resolution. Ensures issues and concerns are being appropriately evaluated, investigated and resolved. Develops and maintains policies and procedures for the general operation of the compliance program and its related activities.
This role is responsible for providing strategy development and project management on the pharmacy enterprise's regulatory, compliance, and diversion prevention programs and serves as the pharmacy department's regulatory and licensing lead. Implicit is the responsibility for customer service and quality services. This position requires a thorough understanding of changing health care systems, including acute care, ambulatory care, outpatient and various alternative sites of care in an integrated health care system. Problems encountered are of a high level of scope and complexity. This position requires a great deal of organizational skill. A considerable amount of innovation, independence, creativity, and flexibility is required in the decision-making and problem-solving process. The scope of issues varies widely as do the number and type of people involved in the problem solving both internal and external to the organization.
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html
Required Qualifications
- Doctor of Pharmacy degree (Pharm D) or equivalent training.
- Advanced knowledge of the methods, tools, and practices involved with regulatory compliance.
- Advanced knowledge and applied background in Pharmacy practice. Knowledge of industry best practices and technology to optimize the use of medication to treat patients. Up-to-date knowledge on pharmacy regulations, drug products, and developments in research and design.
- Advanced organizational and project management skills, with the ability to lead a team, prioritize tasks, and see projects through from inception to completion on schedule.
- Advanced interpersonal skills for collaborating effectively with managers and staff at all levels and across the organization, and with representatives of external regulatory agencies. Skills in coaching and mentoring staff.
- Advanced knowledge of relevant Pharmacy Department, Medical Center, and UC policies and protocols including medicine storage, safety, and patient privacy and treatment. Knowledge of all pharmacy federal and state laws and regulations. Demonstrated understanding of legislative process, applicable regulations, and outside regulatory agencies. Ability to apply policy knowledge to improve workflow systems and protocols.
- Advanced skills in written and verbal communications, with the ability to convey highly-complex technical information, education, and instructions in a clear and concise manner, and to produce high-quality reports, documentation, presentations, and educational materials.
- In-depth ability to collaborate effectively with senior staff and management across departments, providing advice and counsel on complex regulatory issues of functionality, efficiency, and program development.
- Proven ability to set goals and manage the implementation process for initiatives. Ability to cope with rapid change and maintain flexibility in an ambiguous environment.
- Knowledge of organizational structure and critical thinking skills to perform gap analysis and identify improvements in workflow. Demonstrated skills to organize, simplify and increase efficiency of workflows and protocols while maintaining standards and compliance.
- Strong problem-solving skills to evaluate complex or new issues and identify options for resolution when no precedent exists. Demonstrated analytical skills to probe, challenge, and to question the status quo.
- Strong ability to listen actively, consider all points of view with an open mind, soliciting and incorporating ideas when appropriate.
- Minimum of five years' experience or an equivalent combination of education and experience.
- Must have excellent interpersonal skills to interface with a variety of personnel, including physicians, nursing staff, other healthcare providers, pharmaceutical manufacturer representatives, wholesalers, and other administrators.
- Highly adaptive and ability to manage multiple priorities.
- Strong ability to convey complex information clearly and concisely to all levels of staff, management, and outside personnel, with the ability to motivate, influence, and persuade others.
Preferred Qualifications
- Post graduate year 1 and 2 training in Pharmacy Practice, Medication Safety or Hospital Administration, or equivalent experience preferred.
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