Pharmacy Regulatory Compliance Spec.

Washington, District of Columbia-Washington
Aug 19, 2020
Sep 23, 2020
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.


Minimum Education
Doctor of Pharmacy (Pharm.D.)

Specific Requirements and Preferences
Bachelor of Science in Nursing (Required) Or
Doctor of Pharmacy (Pharm.D.) or equivalent experience (Required)

Minimum Work Experience
3 years

Specific Requirements and Preferences
Minimum experience is 3-5 years 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 Req
Pharmacist 30 Days Req

Functional Accountabilities

1. Data collection, analysis, management and presentation
2. Collect, evaluate and submit data and reports to the Compliance Manager and Chief of Pharmacy for analysis and legal purposes
3. Evaluation of processes for the purpose of determining compliance
4. Conduct investigations and audits of current or potential areas of risk
5. Under the direction of the Chief of Pharmacy or Compliance Manager - develop audit processes and processes to track and trend
6. 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
7. Collaborate with departments to implement quality improvement processes to initiate or maintain compliance
8. Other duties assigned

1. Maintain and manage current and accurate documentation and records required for regulatory standards and audits
2. Under the direction of the Chief of Pharmacy and Compliance manager identify tools to increase efficiency and accuracy of auditing practices
3. Assist with the development of up to date drug handling, diversion prevention, detection and reporting policies and procedures.
4. Assist in developing educational materials related to documentation, compliance or procedures
5. Serve as intermediary between patient care units and pharmacy
6. Take suitable action(s) or provides answers to questions of routine pharmacy procedures
7. Facilitate risk assessments and and monitor compliance processes associated with identified risk
8. Interact with physicians, nurses, and other hospital personnel and must be able to refer questions concerns to the proper authorities
9. Participate in Pharmacy and/or Hospital Committees, and QA assignments as assigned.
1. Facilitate the development of compliance with all legal, and regulatory guidelines, practice standards, and laws
1. 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

1. Interact with patients, families, visitors, and fellow employee in a considerate, helpful, and courteous manner.
2. Maintain confidentiality of all hospital and patient information.
3. Promote effective working relations and works effectively as part of a department/unit team to facilitate goals and objectives.
4. Display a positive attitude within the department and across lines in support of the hospital's programs and mission.
5. Perform duties under the auspices of CNH values 3 C's (Commitment, Connection, and Compassion)

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
1. Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication 1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions
Performance Improvement/Problem-solving 1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility 1. Use resources efficiently
2. Search for less costly ways of doing things
Safety 1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

Similar jobs