Pharmacy Manager, Regulatory and Compliance; Mount Sinai Heath System; Full Time Days

Regulatory Compliance Pharmacist

Responsible for all regulatory and compliance related activities, coordination, record keeping and presentation for all of the facilities within the Mount Sinai Health System pharmacies. Works with the Compliance/Regulatory department to plan and coordinate activities of the pharmacy department that enable regulatory compliance to be achieved and maintained. Identifies and supports hospital departments and operational leadership in formulating, integrating and implementing medication related policies, procedures and programs that address regulatory compliance.

Competencies:

• Demonstrates knowledge of the organizations Service Standards and incorporates them into the performance of duties.
• Demonstrates knowledge of the Regulatory and Accreditation Requirements, Rules and Codes and incorporates them into the performance of duties.

Responsibilities

Reviews and disseminates information pertaining to Centers for Medicare & Medicaid Services (CMS), The Joint Commission (TJC), New York State Department of Health (NYSDOH), New York State Office of Mental Health (NYSOMH), and other compliance activities.

Identifies the needs for, as well as designs, implements, and monitors process/activities to assure pharmacy compliance with standards and facilitates ongoing survey readiness.

Pharmacy/Nursing point person for workflow and process updates as it relates to diversion.

Oversees the Drug Diversion Prevention Program including the implementation and maintenance of the Drug Diversion Prevention software

Is accountable for all aspects of drug diversion education, prevention, monitoring, investigation, and reporting in an effort to reduce harm to patients.

Facilitates prioritization of improvement activities related to controlled substance management and shares knowledge as a subject matter expert.

Oversees the compliance as it relates to controlled substance record keeping.

Identifies areas for reporting of required pharmacy information to regulatory agencies.

Communicates departmental progress, areas on concern and problems.

Collaborates with Administrative and Clinical leadership in implementing the Regulatory Readiness Plan. Represents the regulatory perspective through participation on pertinent hospital committees.

Develops and maintains required resource and in-services materials for staff.

Pursues a planned program of professional development through continuing education, seminars, webinars, and applicable journal newsletter and participates in scholarly/professional activities.

Provides a forum for interdisciplinary dialogue for direct care providers (i.e., pharmacy/nursing committee).

Serves as a member of the pharmacy departments' leadership team.

Supports an environment dedicated to the safety of our patients and staff, and facilitate safety-improvement changes in the medication-use physical environment (USP 797/800).

Participates in the development and assessment of a pharmacy quality improvement program.

Designs and manages a QA (Quality Assurance) program for order verification and comprehensive pharmaceutical care.

Oversees all aspects of medication-related policies and procedures i.e., policies and procedures are disseminated, enforced, effective, applicable, up-to-date, and meet regulatory standard.

Precepts pharmacy students and residents as assigned.

Designs and manages pharmacy's compliance audit program.

Duties and Task:

Survey participation for accreditation, reaccreditation, validation, allegation, unannounced regulatory surveys. Provides consultation for pre-survey rounds, survey preparation planning, and follow-up for corrective action implementation.

Orients, educates and works with internal and external staff in performing survey preparation activities including but not limited to Mock Tracers, Secondary Tracers, Safety and Weekly Walk rounds, as well as the Periodic Performance Review (FSA) tool.

Plans, organizes, and coordinates with other departments receipt of information/documentation required to demonstrate compliance with standards and regulations.

Coordinates Pharmacy Regulatory and Compliance initiatives for all pharmacies in the enterprise and ensures all pharmacies are within compliance for Joint Commission.

Implements appropriate changes to policies and procedures based on identified interdisciplinary trends.

Keeps record of all competencies for all Mount Sinai Health System pharmacy sites. Designs and implements CQI (Continuous Quality Improvement) initiatives.

Qualifications

Minimum Qualifications: Bachelor of Pharmacy Degree. Current New York State Pharmacist License. Five (5) years of hospital experience, including experience in process/workflow design and related policy procedure.

Preferred: Advanced Degree (M.S., MHA, PharmD) PGY2 HSPALASHP Pharmacy Accreditation and Regulatory Compliance Certificate

About Us

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

Job Info

• Job Identification 3037310
• Job Category Professional
• Job Schedule Full time
• Job Shift Day
• Locations 150 E 42nd St, New York, NY, 10017, US