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Cedars-Sinai Pharmacy Regulatory Compliance Manager in Los Angeles, California

Are you passionate about helping people? Do you want to make a difference in people's lives?

Cedars-Sinai Medical Center is an 886-bed non-profit, acute, quaternary, teaching Level I Trauma Center hospital located in the heart of Los Angeles, California. The Department of Pharmacy has over approximately 400 staff members who provide comprehensive inpatient pharmacy services as well as outpatient services via 2 cancer centers and 3 outpatient pharmacies. The Department of Pharmacy is committed to the education and training of pharmacists, students/interns, residents, technicians, and other health care professionals. Cedars-Sinai Medical Center (CSMC) is affiliated with several Schools of Pharmacy and offers PGY1 and PGY2 residency programs. The residency and student experiential programs at CSMC continue to grow with every successive year, where nearly 100 residents have graduated from the PGY1 pharmacy residency program since 1985 and more than 200 student rotations are offered at CSMC annually. Recently, CSMC was recognized and bestowed “Site of the Year” awards by two major affiliated CA Schools of Pharmacy for providing an exceptional experiential learning environment for their students.

Do you work well in a large team environment where critical thinking is essential?

As a Pharmacy Regulatory Compliance Manager at Cedars-Sinai Medical Center, you will lead the pharmacy department’s regulatory compliance program and assist the Chief Pharmacy Officer and Pharmacist-In-Charge with quality, regulatory, and performance improvement initiatives. They will ensure compliance with regulatory agencies including but not limited to: The Joint Commission, Department of Public Health, DEA, and California State Board of Pharmacy. You are responsible for supervising the Regulatory and Surveillance Teams.

Problems encountered are of a high level of scope and complexity. This position requires significant organizational, problem-solving and regulatory language interpretation skills as well as emotional intelligence in dealing with both internal and external stakeholders. Employee must take initiative to continually learn and maintain clinical, operational and regulatory knowledge. In this role, you will:

  • Ensure department compliance with state and federal laws, accreditation, professional and other regulatory agencies standards and licensure requirements.

  • Maintain abreast of all current regulatory standards relevant to pharmacy practice.

  • Interpret regulatory requirements and educate Pharmacy and medical center staff on a routine basis.

  • Collaborate with various medical center departments to ensure regulatory compliance of medication management processes.

  • Develops, coordinate, and perform gap analyses, tracers, and other risk evaluations to ensure regulatory compliance.

  • Maintain and update the Pharmacy Policy and Procedure Manual, medication-related policies in the hospital manuals, and Pharmacy regulatory educational materials to ensure compliance with

  • Maintain records of authorized medication storage areas and ensure their monthly inspection as required.

  • Coordinate medication recalls and ensure complete documentation.

  • Coordinate pharmacy staff training and competencies.

  • Coordinate the medical center’s controlled-substance surveillance program.

  • Ensure controlled substance accountability through collaborations with medical center departments including but not limited to Anesthesia, Nursing, Risk Management, Office of Licensure Accreditation and Regulation, and Human Resources on policies/procedures and processes.

  • Develop, coordinate, and perform audits of controlled substance transactions to ensure dose accountability.

  • Serve on the medical center’s controlled substance committees and disseminate relevant information to applicable stakeholders.

  • Maintain complete and accurate records of controlled substance distribution.

  • Educate medical center staff on controlled substance requirements, policies, and best practices for ensuring accountability.

  • Coordinate the PGY2 Health-System Administration and Leadership Resident program in compliance with applicable accreditation standards

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Educational Requirements:

  • Graduate of a School of Pharmacy with a Doctor of Pharmacy Degree

  • Comprehensive knowledge of common disease states and pathologies and their treatment.

  • Knowledge of law, regulations and standards relative to institutional pharmacy practice.

License/Certification Requirements:

  • Graduate of a School of Pharmacy with a Doctor of Pharmacy Degree

  • Current pharmacist licensure in the state of California

Experience:

  • Comprehensive knowledge of pertinent laws and regulations affecting pharmacy practice and health-system operations and of common disease states and pathologies and their treatment.

  • Ability to interpret regulatory language, identify compliance gaps, and implement processes to close identified gaps.

  • Excellent verbal and written communication skills.

  • Ability to manage team performance to achieve goals

Physical Demands:

Physical Requirements (physical abilities essential to perform the job):

  • Frequent standing; walking, bending; reaching, occasional sitting, pushing & pulling, lifting of materials up to 40 pounds for distances to 10 feet.

  • Responsiveness to auditory alarms and communication devices including: telephones, beepers, fire alarms, and mechanical failure alarms.

  • Sufficient mobility to access equipment, patients and other customers.

  • Able to read information on medication labels

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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