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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 aids in maintaining compliance with various government agencies, acts, guidelines, and laws. In addition, the Compliance Specialist is responsible for understanding laws and regulations and their applicability to workflows and organizational processes. A major responsibility 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, and monitor to ensure the process or program follows 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 to develop, achieve, and maintain quality practices and outcomes and demonstrate initiative, collaboration among all disciplines, and accurate assessments of processes. The role requires data collection, analysis, management, and presentation. Excellent communication skills are 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 are 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 Education BSN Bachelor of Science in Nursing (Required) Or Doctor of Pharmacy (Pharm.D.) or equivalent experience (Required) Minimum Work Experience 3-5 years Minimum experience in a hospital setting as a registered nurse or pharmacist Or related work experience (Required) Required Skills/Knowledge Decision Making and Judgment - Professional competence and common sense Equipment - Proficient knowledge of computer applications (i.e., MS Word, E-mail, etc.) Analytic, investigative, and decision-making skills Ability to work with data and draw inferences from multiple sources and types of information Works independently with minimal supervision Ability to work collaboratively with other departments and areas Ability to work on multiple projects and assignments Working knowledge of state, federal, and healthcare regulations Proven time management skills and attention to detail Ability 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 others Required Licenses and Certifications Registered Nurse in District of Columbia Upon Hire (Required) Pharmacist 30 Days (Required) Functional Accountabilities ESSENTIAL DUTIES AND RESPONSIBILITIES Data 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 DUTIES Maintain 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 an intermediary between patient care units and pharmacy Take suitable actions or provide answers to questions of routine pharmacy procedures Facilitate risk assessments and monitor compliance processes associated with identified risks 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 be 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 SERVICE Interact with patients, families, visitors, and fellow employees in a considerate, helpful, and courteous manner Maintain the confidentiality of all hospital and patient information Promote effective working relations and work 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 Accountabilities Organizational Accountabilities (Staff) Anticipate and respond to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Be receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members exhibit unsafe behavior or performance Continuously validate and verify information needed for decision-making or documentation Stop in the face of uncertainty and take time to resolve the situation Demonstrate

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