VP, Regulatory Affairs, Controlled Substances Monitoring Program

McKesson • Richmond, VA

8d • $180,000 - $300,000

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. The Role The VP, Regulatory Affairs, Controlled Substances Monitoring Program (CSMP) will spearhead the development and implementation of McKesson Medical-Surgical’s CSMP during the business’s separation from McKesson Corporation and will lead the CSMP program and team as the separation proceeds. Reporting directly to the SVP, Compliance & Ethics for McKesson Medical-Surgical, the VP will lead the implementation and ongoing oversight of appropriate controls, procedures, and training to ensure compliance with all DEA and state regulations on controlled substances. This highly visible role will collaborate cross-functionally to embed controlled substances regulatory requirements into business operations. The ideal candidate has a strong healthcare compliance or legal background (preferably including the controlled substances regulatory environment), a demonstrated track record collaborating with a wide range of stakeholder groups, experience building compliance programs in complex regulatory areas, and strong leadership skills to foster a culture of compliance and accountability across the organization, including with senior leadership and Board of Directors stakeholders. The VP will also represent the separated Medical-Surgical business externally with regulators, manufacturers, customers, and industry groups on controlled substances areas. About Medical-Surgical McKesson Medical-Surgical (MMS) is a subsidiary and publicly reported segment of the McKesson Corporation. MMS distributes medical-surgical supplies, pharmaceuticals, diagnostic equipment and supplies, along with other solutions and services to virtually every type of healthcare setting and provider outside of the traditional hospital. These markets – often referred to as Alternate Care or Non-Acute Care – include physician offices, surgery centers, long-term care providers, laboratories, home health and hospice agencies, health systems, government facilities and online marketplaces and retailers. Alternate Care markets are growing rapidly and MMS is proud to be a leader in this space. With a team of approximately 8,000 employees, a network of 15 distribution centers and approximately 900 delivery vehicles, we partner with more than 2,200 leading manufacturers and serve over 200,000 customer accounts across the U.S. Our catalog includes more than 280,000 SKUs of branded and private-label medical-surgical products – from bandages to specialty pharmaceuticals and COVID-19 tests. Looking Ahead: A New Chapter for MMS McKesson has announced its intent to separate MMS into an independent company – an exciting evolution that builds on MMS’s strong foundation and proven leadership in the Alternate Care space. As a standalone company, MMS would be positioned to unlock new opportunities to innovate, grow and lead with even greater agility and focus. We will also continue to be one of the largest medical-surgical distributors in the U.S., with over $11B in annual sales. This separation would accelerate our mission and empower us to shape a future defined by customer-centricity, bold thinking and operational excellence. For job seekers, it’s a unique moment to join a team that’s already making a meaningful impact and leading the way in shaping the future of healthcare delivery in Alternate Care settings – with even greater opportunity ahead as we prepare to become an independent company.

Requirements

• A minimum of 10 years of relevant work experience, including experience in building and managing healthcare compliance programs in highly regulated areas.
• Experience with executive level and/or Board of Directors reporting.
• Legal professional with familiarity and experience with controlled substance issues who has managed controlled substance compliance programs or controlled substances litigation, or someone who has held senior level roles at the DEA, State Boards of Pharmacy and other enforcement agencies, or at a distributor CSMP.
• Experience in the healthcare industry with an understanding of the pharmaceutical ecosystem.
• Broad experience operating compliance or regulatory programs relating to controlled substance monitoring.
• Experience leveraging data and analytics to create sustainable and effective controls.
• Significant experience with the rules and regulations governing the conduct of pharmaceutical manufacturers and distributors, healthcare providers, pharmacies, and other market participants in the controlled substance arena.
• Significant experience working collaboratively on cross-functional teams.
• Significant experience working with government agencies.
• Significant experience recruiting, training, coaching, and retaining team members.
• Influencing and Collaborating: The VP should have demonstrated experience successfully establishing a culture of compliance, proactively addressing risk, and leading a modern, fully integrated business-oriented legal or compliance program in a healthcare company. He or she should also have the demonstrated ability to develop strong relationships across a company, ideally in a matrixed environment, as well as with relevant government regulators. The VP should have strong executive presence, outstanding influencing and collaborating skills and business acumen, and the ability to serve as an ambassador and influencer for compliance strategy. He or she should present with great credibility and have a strong reputation for honesty, integrity and ethical behavior.
• Business Acumen: The VP should possess a deep understanding of business and key business drivers. He or she will be expected to leverage this knowledge to create a vision of how risk-based compliance initiatives can work effectively, practically and coherently throughout our organization. The VP will work with business and legal colleagues to approach problems in a pragmatic fashion, fostering ethical and compliant behavior without unnecessarily restricting the business of the Company.
• Management: The VP should be a strong and confident leader with the demonstrated ability to attract and develop talent. He or she should also have a proven commitment to the creation of a positive working environment within a compliance and regulatory organization and of enhancing morale and engagement.
• Excellent written and oral communication skills, including the ability to communicate to all organizational levels and externally.
• Advanced project management skills.
• Strong influencing and partnership skills.
• Relationship builder.
• Strategic, business-oriented and pragmatic.
• High learning agility.
• Resilient and tenacious.
• An outstanding record of academic achievement, including an undergraduate degree in a related field.

Nice To Haves

• Law degree preferred.

Responsibilities

• Program Development and Implementation: Ensure the development and implementation of an effective CSMP program and controls framework for MMS designed to comply with federal and state laws and regulations. Drive execution of all program deliverables to support the overall MMS separation timeline.
• Cross-Functional Collaboration: Partner with cross-functional teams – including Operations, Sales, Quality, Legal, Internal Audit, IT, and others – to integrate CSMP requirements into business processes. Develop and maintain relationships externally to support our efforts.
• Leadership and Team Management: Upon establishment of standalone MMS controlled substances capabilities, lead a team of CMSP professionals, ensuring alignment around priorities, performance against goals, coaching and development, and talent planning.
• Program Oversight and Leadership: Provide ongoing oversight to the CSMP program, including monitoring and testing effectiveness, conducting risk assessments, and driving continuous improvement to the program. Serve as the subject matter expert for the business on the CSMP program, advocating and translating regulatory requirements into actionable and sustainable controls. Leverage technology and leading approaches to continuously innovate and enhance the program.
• Training, Communication and Awareness: Implement targeted training programs, communications, and awareness initiatives to educate relevant business stakeholders (e.g. sales teams, operations, distribution centers, senior leadership) on CSMP policies and procedures. Build and maintain a strong culture of compliance by ensuring open lines of communication for raising concerns and by championing the importance of controlled substance compliance at all levels.
• Analytics and Monitoring: Develop data models in partnership with internal and external experts to identify and address distribution and dispensing trends. Implement and execute external regulatory reporting requirements. Develop data insights and reports for internal stakeholders. Develop metrics and dashboards to report on program performance, and use analytical insights to proactively mitigate risks and enhance controls.
• Governance and Oversight: In partnership with the SVP, Compliance & Ethics, establish CSMP governance and oversight processes and reporting for senior leadership and the Board of Directors.
• Regulatory Reporting and Agency Engagement: Manage all required regulatory reporting requirements. In partnership with the Legal team and other business stakeholders, ensure timely, transparent communication with regulators, handle regulatory inquiries or inspections in, and lead the organization’s response to any issues related to controlled substances.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive