Senior Healthcare Legal Counsel - Compliance and Ethics

at  Morgan McKinley

Role
The Vice President (VP) of Compliance and Ethics will play a pivotal role in overseeing the compliance program for the organisation’s pharmaceutical private label businesses. These businesses manufacture, repackage and/or source generics and over-the-counter (OTC) pharmaceutical products globally, for subsequent distribution and commercialization in North America. In addition to supporting the Private Label businesses, the VP will also coordinate and/or lead the development of McKesson’s enterprise standards in specialised program areas such as U.S. Federal and State government price reporting, international compliance, and third-party supplier due diligence. This role will report directly to the SVP, Compliance and Ethics within the General Counsel Organisation.
The ideal candidate will have significant legal and/or compliance experience in the healthcare industry. They will have broad familiarity with the laws and regulations governing the activities of pharmaceutical manufacturers, suppliers, and distributors. Additionally, this individual will have a strong executive presence and the demonstrated ability to effectively collaborate with large teams consisting of Business, Legal, Compliance, Quality, Audit, and HR colleagues in a highly matrixed environment.

Key Responsibilities

• Advising Private Label leadership teams on complex matters and providing solution-oriented compliance guidance for daily operational activities, new/emerging offerings, and growth strategies.
• Implementing and maintaining an effective compliance program for Private Label, with a particular focus on “upstream” processes such as product and portfolio management, channel strategy, manufacturing, sourcing, and other supply-chain-related activities (e.g., know your supplier and supplier compliance programs).
• Working closely with compliance department peers supporting other distribution businesses to ensure seamless integration of Private Label products into “downstream” commercial compliance activities.
• Partnering with Private Label business leaders and operational owners to identify and proactively mitigate risks in areas such as, but not limited to, government price reporting, controlled substances anti-diversion programs, government contracting, anti-bribery & corruption, international trade, responsible sourcing, interactions with healthcare professionals, data privacy, and other regulations.
• Building and managing a team of compliance professionals, ensuring their engagement and development.
• Drafting and implementing effective policies, procedures, and training.
• Building a robust compliance training program for employees and business partners; delivering custom training to relevant audiences.
• Establishing and supporting effective business processes and controls to ensure regulatory and compliance obligations are met, including timely remediation of identified gaps.
• Providing expertise and assisting various other organisation businesses in implementing policies, processes and controls in specialized areas such as government price reporting, international compliance programs, supplier due diligence and other relevant risk areas.
• Supporting the SVP in special projects, risk-assessments, integrations, investigations and other relevant activities.
• Supporting the organization’s goals while fostering a strong culture of compliance.

Qualifications

Minimum Requirements

• Qualified lawyer with 12+ years of experience in a related field, including building and managing healthcare compliance programs.

Critical Skills

• Player-coach mindset with a history of hands-on execution, while leading high-performing teams.
• Strong thought leadership skills with a bias for action, balancing vision setting with rigorous and timely execution.
• Clear thinking and excellent writing skills for drafting easy-to-understand policies, training, and guidance.
• Strong presentation skills for delivering concise and effective presentations to senior business leaders.
• Broad experience planning, developing, implementing, monitoring, and managing compliance programs in the healthcare industry, preferably with exposure to pharmaceutical private label and supply-chain programs.
• Cultural sensitivity and experience dealing with global teams, and exposure to compliance topics that may arise from conducting business worldwide.
• Significant experience with rules, regulations, and industry guidelines governing the medical device and pharmaceutical industry worldwide.
• Familiarity with sophisticated programs to comply with manufacturer’s U.S. government price reporting and rebate payment obligations (e.g., Medicaid Drug Rebate Program, 340B Drug Pricing Program, Medicare Part B ASP Program, and other relevant State pricing reporting regulations).
• Excellent analytical, problem-solving, and decision-making skills for identifying and mitigating compliance risks effectively.
• Outtanding interpersonal skills for building relationships and collaborating with cross-functional teams.
• Strong leadership abilities, including significant experience recruiting, training, inspiring, and motivating a team of compliance professionals.
• Advanced project management and data analysis skills.
• Highest level of integrity and ethics, commitment to maintaining the highest standards of compliance.
• Willingness to travel, including internationally, as needed.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

Key Responsibilities

• Advising Private Label leadership teams on complex matters and providing solution-oriented compliance guidance for daily operational activities, new/emerging offerings, and growth strategies.
• Implementing and maintaining an effective compliance program for Private Label, with a particular focus on “upstream” processes such as product and portfolio management, channel strategy, manufacturing, sourcing, and other supply-chain-related activities (e.g., know your supplier and supplier compliance programs).
• Working closely with compliance department peers supporting other distribution businesses to ensure seamless integration of Private Label products into “downstream” commercial compliance activities.
• Partnering with Private Label business leaders and operational owners to identify and proactively mitigate risks in areas such as, but not limited to, government price reporting, controlled substances anti-diversion programs, government contracting, anti-bribery & corruption, international trade, responsible sourcing, interactions with healthcare professionals, data privacy, and other regulations.
• Building and managing a team of compliance professionals, ensuring their engagement and development.
• Drafting and implementing effective policies, procedures, and training.
• Building a robust compliance training program for employees and business partners; delivering custom training to relevant audiences.
• Establishing and supporting effective business processes and controls to ensure regulatory and compliance obligations are met, including timely remediation of identified gaps.
• Providing expertise and assisting various other organisation businesses in implementing policies, processes and controls in specialized areas such as government price reporting, international compliance programs, supplier due diligence and other relevant risk areas.
• Supporting the SVP in special projects, risk-assessments, integrations, investigations and other relevant activities.
• Supporting the organization’s goals while fostering a strong culture of compliance