Regulatory and Compliance Specialist

Regulatory and Compliance Specialist

Pharmacy Medication Safety

Full Time

86273BR

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

Department Description

The Department of Pharmaceutical Services at UCSF has long been nationally recognized as one of the founding fathers for clinical pharmacy services, which was established in 1965. Today, the department continues to lead the profession through the integration of advanced technology & robotics, comprehensive pharmaceutical care and clinical services.

The Department of Pharmacy includes approximately 600 FTE and an annual operating budget of over $1 billion (see below for more detail.) The Department provides services at Parnassus, Mission Bay, Benioff Oakland, Owens, Mt. Zion, St. Mary's and Saint Francis as well as multiple ambulatory and outpatient locations and working with affiliates and in inpatient and outpatient settings.

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

License / Certification

About UCSF

At UCSF Health, our mission of innovative patient care, advanced technology and pioneering research is redefining what's possible for the patients we serve - a promise we share with the professionals who make up our team.

Consistently ranked among the top 10 hospitals nationwide by U.S. News & World Report - UCSF Health is committed to providing the most rewarding work experience while delivering the best care available anywhere. In an environment that allows for continuous learning and opportunities for professional growth, UCSF Health offers the ideal atmosphere in which to best use your skills and talents.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Organization

Health

Job Code and Payroll Title

006530 REGL AND CMPLNC HC SPEC 5

Job Category

Allied Health, Pharmacy

Bargaining Unit

99 - Policy-Covered (No Bargaining Unit)

Employee Class

Career

Percentage

100%

Location

San Francisco, CA

Campus

TBD

Work Style

Hybrid

Shift

Days

Shift Length

8 Hours

Additional Shift Details

M-F