Regulatory Affairs Manager

McKesson
22hRemote

About The Position

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you. McKesson’s Controlled Substances Monitoring Program (CSMP) is seeking a Regulatory Affairs Manager (RAM) to join our team in support of our SoCal, Sacramento, and Honolulu Distribution Centers. This role is a work-from-home position with a candidate location requirement of California, Nevada, Arizona, or New Mexico. This position plays a critical role supporting the regional Director of Regulatory Affairs through due diligence assessments and controlled substance data analysis for our Community Pharmacy and Health segment customers.

Requirements

  • Degree or equivalent and typically requires 4+ years of relevant experience.
  • Four-year degree in a related field or equivalent experience.
  • 4+ years of experience in regulatory compliance.
  • Able to work independently and deal with complexity and ambiguity in a dynamic environment.
  • Able to manage multiple assignments, optimally prioritize, and make effective use of time based on internal and external factors.
  • Able to make sound, regulatory decisions by leveraging interviews, data analysis, and relevant information from other pertinent sources.
  • Organized, results-driven, resourceful, and can use tact and sound judgement when dealing with customers and teammates.
  • Strong interpersonal skills that support effective internal and external stakeholder engagement.
  • Able to thrive in a fast-paced, yet detail oriented, environment.
  • Excellent verbal and written communication skills including the ability to communicate clearly and confidently at all levels.
  • Embrace diversity of people, thought, and style.
  • Seek opportunities to improve operational excellence through people, processes, and technology.
  • Proficient computer skills, including Microsoft Office applications
  • Possess a high-speed internet connection.
  • Able to travel up to 10%

Nice To Haves

  • Controlled substances compliance experience, pharmacy, or federal/state pharmaceutical regulatory enforcement backgrounds are a plus.
  • Salesforce knowledge is a plus.

Responsibilities

  • Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.
  • Interview pharmacists-in-charge, pharmacy ownership, and other staff as needed.
  • Conduct pharmacy site visits as needed in support of customer due diligence reviews.
  • Conduct statistical analysis of controlled substance ordering and dispensing data to support due diligence efforts and identify controlled substance trends and anomalies.
  • Prepare detail-oriented reports to document due diligence reviews and statistical analyses.
  • Engage with sales account managers and other CSMP team personnel as needed to support program efforts.
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