Manager Pharmacy Regulatory Affairs Compliance United States
Manages regulatory intake process to advise upon current and future operational impact due to current regulatory requirements (laws/regulations) and policies/procedures/operating guidelines. Serve as KP liaison to local, state, and federal regulatory agencies that impact pharmacy practice for specific federal and state jurisdictions. Oversee development and implementation of pharmacy training in compliance related subject areas.
Responsible for leading compliance initiatives both within the compliance function as well as other functions across the enterprise, managing relationships and maintaining communications with stakeholders at all levels. Accountable for brokering agreements and gaining support for compliance initiatives from decision makers at all levels. Leads and directs the researching, planning, implementation, and monitoring, validation, and reporting for a broad portfolio of compliance systems and initiatives to enable organizational compliance with all applicable Federal, state, and local regulations/laws, and overseeing the protection of organizational assets. Oversees the researching and interpretation of regulations and laws to establish compliance standards, and may direct the development and/or delivery of training and communications/change management relative to new standards.
Is responsible for the Assessment of organizational systems (both physical and process or data related) to determine gaps in compliance and determine opportunities for remediation. Advises the organization on all compliance matters. May direct the investigation of violations of compliance policy, laws, regulations, etc. or on-going monitoring and reporting to ensure remediation. May be responsible for project management relative to new compliance, ethics and integrity initiatives, products, or annual processes.
- Personnel Management: Manages the efforts of direct reporting, as well as matrix reporting, positions. Responsible for selecting, developing, and deploying personnel in the most effective manner to meet assigned objectives. Responsible for performance management, compensation decisions, and providing on-going, regular developmental feedback.
- Communications, Stakeholder Management, and Facilitation: Facilitates communications, manages relationships with stakeholders, and garners support and agreement from involved parties for compliance initiatives and programs in assigned functional areas.
- Issue Management, Response, and Mitigation: Responsible for issue management, response, and mitigation in assigned functional areas. Anticipates issues through regular communication with reporting positions, mitigating risk or escalating issues for resolution by more senior levels as necessary.
- Change Management: Responsible for leading change management efforts related both to specific functional areas as well as larger departmental goals or objectives. Identifies and acts upon opportunities to leverage direct reporting team in change management activities; ensures direct reporting team is engaged in change management as appropriate.
- Project Management: Responsible for management of project plans for individual objectives or projects as well as ensuring project timelines and objectives are met for projects managed by reporting positions.
- Strategic development: Provides information relative to the identification and development of objectives, goals, and strategy relative to individual functional area. May participate in development of same.
- Ability to identify, analyze and craft responses to address regulatory affairs issues during consultation on internal projects and within correspondence from regulatory agencies.
- Manage regulatory responses to agencies, such as to the state Board of Pharmacy, and conduct investigations pursuant to.
- Maintain oversight and provide regulatory guidance to operations relating to compliant licensing of pharmacy facilities.
- Build and strengthen liaison relationship between National Pharmacy Compliance, National Legal department, and regional legal departments or stakeholders to collaborate on pharmacy legal and compliance issues.
- Manage employees within the department to achieve regulatory compliance objectives.
- Knowledge and experience related to establishing and leveraging liaison relationships with regulatory agencies.
- Able to analyze complex, multivariate challenges involving pharmacy regulatory and compliance issues.
- Minimum two (2) years of management experience.
- Minimum eight (8) years of compliance-related experience.
- Bachelor's or clinical degree, OR four (4) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- Expert knowledge of compliance policies, practices and systems.
- Develops advanced compliance principles, theories, and concepts.
- Expert knowledge of compliance-related practices and standards.
- Project management skills.
- Must be able to work in a Labor/Management Partnership environment.
-Pharmacy Doctorate of Juris Doctorate Preferred.
-Experience in pharmacy practice, as licensed pharmacist, including experience in pharmacy operations in a variety of settings preferred.
-Expert knowledge of pharmacy compliance policies, practices and systems.
-Thorough knowledge of applicable federal, state, and local laws & regulations.
-Experience in developing, drafting, and revising compliance and regulatory affairs related documents including but not limited to: submissions to regulatory agencies, policies, standards, analyses, and reports.
-Experience in developing dashboards and processes to track and trend regulatory affairs matters and internal projects.
-Experience with oversight of multiple health care facilities within a health system.
Primary Location: United States,United States,Downey
Scheduled Hours (1-40): 40
Working Days: Mon - Fri
Job Type: Standard
Employee Status: Regular
Employee Group: Salaried, Non-Union, Exempt
Job Level: Manager with Direct Reports
Job: Compliance / Privacy / Regulatory
Public Department Name: National Compliance Ethics & Integrity Office
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.
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