Regulatory Affairs Manager

at  McKesson

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 Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments, and other organizations in healthcare to help provide the right medicines, medical products, and healthcare services to the right patients at the right time, safely and cost-effectively. United by our I2CARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful - all for the better health of patients. McKesson has been named a “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more information, visit www.mckesson.com.
We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities, and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us. Apply to join our team and help shape the future of healthcare!

POSITION DESCRIPTION

McKesson’s Controlled Substances Monitoring Program (CSMP) is seeking a Regulatory Affairs Manager (RAM) to join our team in support of our McKesson Health Systems (MHS) team. This role is a work-from-home position with no geographic location requirement.
This position plays a critical role supporting the MHS Director of Regulatory Affairs through due diligence assessments and controlled substance data analysis for our health system pharmacy customers.

EDUCATION

Four-year degree in a related field or equivalent experience.

CRITICAL SKILLS

• 4+ years of relevant experience in regulatory compliance. Controlled substances compliance experience, pharmacy, or federal/state pharmaceutical regulatory enforcement backgrounds are a plus.
• 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.

ADDITIONAL REQUIREMENTS

• Proficient computer skills, including Microsoft Office applications; Salesforce knowledge is a plus.
• Possess a high-speed internet connection.

• Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.
• Interview pharmacists-in-charge/directors of pharmacy, health systems compliance leadership, and other staff as needed.
• 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, health system compliance teams, and other CSMP team personnel as needed to support program efforts.
• Conduct pharmacy site visits as needed in support of customer due diligence reviews.