We are seeking a Pharmacy Compliance Counsel to join our legal team. This position requires a highly motivated attorney with a Juris Doctorate (JD) and an active bar admission. As part of our team, you will provide legal guidance on pharmacy regulatory compliance, ensuring our organization adheres to all state and federal laws related to the pharmaceutical industry.
This role requires extensive experience in advising stakeholders on pharmacy compliance laws, experience in pharmacy compliance program design, a strong legal background, and a deep understanding of regulatory frameworks, risk management, and governance practices related to the pharmacy industry. The Pharmacy Compliance Counsel will develop and implement comprehensive compliance programs to ensure adherence to legal and regulatory requirements across all facets of our organization. This position will report up to the Chief Legal Officer and will work closely with a small team of compliance professionals to execute pharmacy compliance initiatives effectively.
Accelerate Your Career as You
- Guide on Legal Aspects of Pharmacy Practice and Pharmacy Operation: Provide sound and seasoned legal advice and direction on pharmacy regulatory laws, rules and regulation and deliver guidance and support to departments and business units on compliance-related matters, including regulatory interpretations, licensing requirements, and reporting obligations.
- Drive Compliance Strategy: Take day-to-day ownership of and drive implementation of an effective compliance strategy in line with regulatory standards and company objectives.
- Manage Compliance Programs: Develop and manage compliance programs, incorporating best practices with an eye to preventing and mitigating compliance risks.
- Collaborate with Cross-Functional Teams: Work with cross-functional teams to integrate compliance objectives into business processes, product development, and strategic initiatives.
- Stay Current with Laws and Regulations: Keep abreast of relevant laws, regulations, and industry best practices to ensure compliance programs and practices remain current and effective.
- Regulatory Liaison: Serve as a primary point of contact for regulatory agencies, external auditors, and outside legal counsel on compliance-related inquiries and investigations.
- Reporting and Presentations: Prepare and present regular reports to senior management and the board of directors on compliance activities, findings, and recommendations, along with education on trending regulatory laws and other regulatory developments.
- Identify Emerging Risks: Proactively identify emerging compliance risks and develop measures to address potential issues before they escalate.
A Bit About You
Minimum Qualifications:
- Bachelor’s degree.
- JD from an accredited law school.
- 8+ years of legal experience in healthcare with at least 5 years within the pharmacy industry.
- Comprehensive understanding of pharmacy regulations, with experience navigating the complexities of various states' regulatory landscapes.
- Comprehensive understanding of other laws affecting the pharmacy industry and pharmacy operations (CSA, HIPAA, FDA/DSCSA).
- In-depth knowledge of relevant regulatory requirements and industry standards, with a strong understanding of compliance principles and practices.
- Excellent communication skills, with the ability to influence and collaborate across all levels of the organization.
- Strong analytical skills and attention to detail.
- Demonstrated ability to manage multiple priorities and deadlines in a fast-paced environment.
Preferred Qualifications:
- PharmD.
- Expertise in interpreting Board of Pharmacy regulations in digital or non-traditional pharmacy settings.
- Prior involvement in investigations and complaints within the pharmacy sector, with a track record of successfully managing compliance legal challenges.
- Regulatory experience and intelligence, with the ability to discern critical regulatory requirements and prioritize compliance efforts accordingly.
- Familiarity with compliance requirements across all 50 states in retail, specialty, and mail-order pharmacy operations on a large scale.
- Experience in both start-up and big-chain pharmacy environments, with an understanding of the challenges and opportunities inherent in each.
- Accreditation and policy management experience.
Additional Physical Job Requirements:
- Reading English, comprehending, and following simple oral and written instructions.
- The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; assessing the accuracy, neatness, and thoroughness of the work assigned.
- Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
- Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
- Frequent repeating motions required to operate a computer or phone that may include the wrists, hands and/or fingers.
- Environmental Conditions: occasional exposure to low temperatures or high temperatures, outdoor elements such as precipitation and wind, and noisy environments.
- Physical Activities:
- Occasionally ascending or descending stairs, ramps and the like.
- Moving about to accomplish tasks and/or moving from one worksite to another.
- Adjusting or moving objects up to 20 pounds in all directions.
- Operating motor vehicles.
- Occasional sedentary work that primarily involves sitting/standing/driving/flying.
Salary and Benefits
Salary Range: $180,000 - $225,000
Commission Eligible: No
Equity Eligible: Yes
Travel: Yes. Up to 25% of the time to visit pharmacy sites.
Location Requirement: Employment at Alto is limited to individuals residing in the following states: California, Connecticut, Colorado, Florida, Nevada, Illinois, New York, Kansas, Texas, Maryland, Washington (WA), Missouri, New Jersey, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Wisconsin.
Employment Requirement: Applicants must be authorized to work for any employer in the U.S. At this time, Alto is unable to sponsor or take over sponsorship of an employment Visa.
Benefits: Full-time: Medical, Dental, Vision, 401(k), Group Life, AD&D, Employer paid STD/LTD, generous PTO and parental leave.
Application deadline: October 15, 2024
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