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Pharmacy Regulatory Compliance Specialist

2 months ago


Washington, United States Children's National Hospital Full time

Under the direction of the Chief of Pharmacy, or Pharmacy Compliance Manager, the Pharmacy Regulatory Compliance Specialist is responsible for ensuring the delivery of quality pharmacy services by providing leadership, direction, and technical expertise in the planning, development, coordination, implementation, and evaluation of Compliance issues related to regulatory or practice standards. The Pharmacy Compliance Specialist aides in maintaining compliance with a number of government agencies, acts, guidelines and laws. In addition, the Compliance Specialist is responsible for going beyond knowing the laws and regulations and their applicability to workflows and organizational processes. A major responsibility, under the direction of the Chief of Pharmacy or Compliance Manager is to facilitate, coordinate or conduct investigations and audits to identify areas of risk, draft a process improvement plan in collaboration with other departments or areas to improve compliance to address the risk, and monitor to ensure the process or program is following best practices and established standards. This position requires cross-functional collaboration with multiple disciplines to produce quality outcomes related to organizational compliance with regulatory, state and federal standards. It requires an in-depth understanding of clinical practice, in order to develop, achieve and maintain quality practices and outcomes and independent demonstration of initiative, collaboration among all disciplines and accurate assessments of processes. The role requires data collection, analysis, management and presentation. Excellent communication skills is a must.This position requires coordinating quality services, with Clinical Services, in efforts to integrate, implement, and develop procedures, policies, and protocols. Pharmacy Compliance Specialists is responsible for facilitating meetings with other hospital departments to assist with analysis, planning and implementation of compliance issues. The Pharmacy Compliance Specialist must comply with current departmental and institutional policies, as well as, regulations set aside by regulatory bodies (i.e. The Food and Drug Administration, Drug Enforcement Administration, Department of Health, The Joint Commission). The Pharmacy Compliance Specialist is responsible for attending regular committee meetings as assigned and mandatory staff meetings.Qualifications:Minimum EducationBSN Bachelor of Science in Nursing (Required) OrDoctor of Pharmacy (Pharm.D.) Doctor of Pharmacy (Pharm.D.) or equivalent experience (Required)Minimum Work Experience3 years Minimum experience is 3-5 years in a hospital setting as a registered nurse or pharmacist Or related work experience (Required)Required Skills/KnowledgeDecision Making and Judgment - Professional competence and common senseEquipment - Proficient knowledge of computer applications (i.e. MS Word, E-mail, etc.)Analytic, investigative and decision making skillsAbility to work with data and draw inferences from multiple sources and types of informationWorks independently, with minimal supervisionAbility to work collaboratively with other departments and areasAbility to work on multiple projects and assignmentsWorking knowledge of state, federal and healthcare regulationsProven time management skills and attention to detailAbility to work professionally in collaboration with multiple areas, with providers on all levels ( excellent interpersonal and professional skills)Self-motivated with a positive attitude when collaborating, training or presenting to othersRequired Licenses and CertificationsRegistered Nurse in District of Columbia Upon Hire (Required)Pharmacist 30 Days (Required)Functional AccountabilitiesESSENTIAL DUTIES AND RESPONSIBILITIESData collection, analysis, management and presentation Collect, evaluate and submit data and reports to the Compliance Manager and Chief of Pharmacy for analysis and legal purposes Evaluation of processes for the purpose of determining compliance Conduct investigations and audits of current or potential areas of risk Under the direction of the Chief of Pharmacy or Compliance Manager - develop audit processes and processes to track and trend Under the direction of the Chief of Pharmacy or Compliance Manager - map out risk assessments based on practice standards or workflow throughout the organization with areas Collaborate with departments to implement quality improvement processes to initiate or maintain compliance Other duties assigned OPERATIONAL DUTIESMaintain and manage current and accurate documentation and records required for regulatory standards and audits Under the direction of the Chief of Pharmacy and Compliance manager identify tools to increase efficiency and accuracy of auditing practices Assist with the development of up to date drug handling, diversion prevention, detection and reporting policies and procedures. Assist in developing educational materials related to documentation, compliance or procedures Serve as intermediary between patient care units and pharmacy Take suitable action(s) or provides answers to questions of routine pharmacy procedures Facilitate risk assessments and and monitor compliance processes associated with identified risk Interact with physicians, nurses, and other hospital personnel and must be able to refer questions concerns to the proper authorities Participate in Pharmacy and/or Hospital Committees, and QA assignments as assigned. Facilitate the development of compliance with all legal, and regulatory guidelines, practice standards, and laws Remain abreast of and is responsive to department communications via e-mails, staff meeting attendance [monthly meetings are mandatory with absence requiring management notice/approval], mailings and distributed literature CUSTOMER SERVICEInteract with patients, families, visitors, and fellow employee in a considerate, helpful, and courteous manner.Maintain confidentiality of all hospital and patient information.Promote effective working relations and works effectively as part of a department/unit team to facilitate goals and objectives.Display a positive attitude within the department and across lines in support of the hospital's programs and mission.Perform duties under the auspices of CNH values 3 C's (Commitment, Connection, and Compassion)Organizational AccountabilitiesOrganizational Accountabilities (Staff)Organizational Commitment/Identification Anticipate and responds to customer needs; follows up until needs are metTeamwork/Communication Demonstrate collaborative and respectful behaviorPartner with all team members to achieve goalsReceptive to others' ideas and opinionsPerformance Improvement/Problem-solving Contribute to a positive work environmentDemonstrate flexibility and willingness to changeIdentify opportunities to improve clinical and administrative processesMake appropriate decisions, using sound judgmentCost Management/Financial Responsibility Use resources efficientlySearch for less costly ways of doing thingsSafety Speak up when team members appear to exhibit unsafe behavior or performanceContinuously validate and verify information needed for decision making or documentationStop in the face of uncertainty and takes time to resolve the situationDemonstrate accurate, clear and timely verbal and written communicationActively promote safety for patients, families, visitors and co-workersAttend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance