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SalaryPosition Summary:
The Regulatory & Compliance Pharmacist at Empower is not just a guardian of compliance but also a catalyst for continuous improvement, ensuring that our operations align with current regulations and set a benchmark for excellence in the compounding pharmacy sector. This role is instrumental in maintaining Empower's reputation for quality and integrity in healthcare. Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Knowledge and Skills:
Additional Voluntary Benefits
At Empower, the Regulatory & Compliance Pharmacist is pivotal in upholding the integrity and compliance of our 503A operations, directly supporting the Pharmacist-in-Charge (PIC). This role is central to ensuring that our practices, products, and promotional materials meet the stringent regulations set by the DEA, FDA, USP, and State Boards of Pharmacy, maintaining Empower's commitment to quality and safety.
The Regulatory & Compliance Pharmacist at Empower is not just a guardian of compliance but also a catalyst for continuous improvement, ensuring that our operations align with current regulations and set a benchmark for excellence in the compounding pharmacy sector. This role is instrumental in maintaining Empower's reputation for quality and integrity in healthcare.
- Conducts regular reviews of compounding pharmacy products on the market to ensure adherence to industry regulations and standards
- Reviews essential copy guidance provided by the FDA and ensures all products produced by Empower comply with regulatory requirements
- Reviews marketing and promotional materials to ensure accuracy and adherence to company standards
- Assists the PIC with onsite and remote audits and record requests
- Evaluates internal operating controls, processes and practices and provides recommendations for improvements. Works with PIC to determine potential risks associated with current practices
- Develops Standard Operating Procedures and Work Instructions and prepares training materials for internal teams. May Occasionally provide training.
- Prepares reports and presents data as needed
- Remains current on Federal and State laws, regulations, and guidance to address organizational business needs and assists PIC with communicating regulatory updates to internal teams
- Conducts regular audits to oversee process flows and ensure adherence to standard operating procedures in addition to state and federal laws, regulations, and guidance
- Ensures all audit issues are documented in the applicable compliance and audit programs
- Tracks progress on special projects and provides updates to PIC
- Performs other duties as assigned
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.
- Familiarity with related regulatory matters and compliance initiatives
- Proficient in Microsoft Office (Excel, PowerPoint, etc.)
- Ability to work independently to manage work tasks effectively
- Must be detail-oriented and possess a high level of accuracy
- Excellent verbal and written communication skills
- Ability to work in a fast-paced and changing environment while adapting to changing responsibilities and coordinating multiple job tasks
- Ability to prioritize work and meet deadlines
- Must be a self-starter and results driven
- Sensitivity to confidential documents and information
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives
- Resourcefulness: Secures and deploys resources effectively and efficiently
- Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems
- Ensures Accountability: Holds self and others accountable to meet commitments and objectives
- Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations
- Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences
- Bachelor’s degree in pharmacy or PharmD required
- Texas licensed Pharmacist
- Current state pharmacy license in good standing
- 3 to 5 years of relevant work experience required
- Experience implementing and maintaining compliance systems preferred
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden
- Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels
- Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family
- Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family
- Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off
- Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions
- Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance
- FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA)
- 401K Dollar-for-Dollar Up to 3%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 3%
- Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time
- Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options
- Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck
Additional Voluntary Benefits
- Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury
- Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays
- Critical Illness: Protect your finances from the expenses of a serious health issue
- Short-Term Disability: Protect your income during illness or injury with short-term disability coverage
- Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage
- Legal Services: Access professional legal assistance to address concerns confidently
- Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit
- Pet Insurance: Care for your furry family members with our pet insurance coverage
- Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being
