Lead Counsel - FDA

McKesson is an impactdriven 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 wellbeing 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 tomorrows health today we want to hear from you.

Title: Lead Counsel FDA

Preferred location: Washington DC

Other locations: Atlanta GA; Dallas TX

Hybrid/Remote/Onsite: Hybrid position

Current Need

McKessons General Counsel Organization (GCO) seeks a Lead Counsel FDA to provide strategic legal advice on matters related to Food & Drug Administration (FDA) regulation. GCO is comprised of Legal Compliance Corporate Affairs and Enterprise Quality. The GCOs mission is: Together we enable Team McKesson to advance our enterprise strategy navigate complexity and shape healthcare with integrity creativity and agility.

The Lead Counsel will play a critical role in quality and regulatory excellence across McKesson and thus help McKesson live its Purpose of Advancing Health Outcomes for All. The Lead Counsel will be part of the General Counsel Organizations Litigation Investigations and Regulatory group and will work closely with the legal compliance and operational teams supporting our North American business units on the full portfolio of McKessons FDAregulated offerings. As an expert in FDA and healthcare regulations the Lead Counsel will be particularly engaged on issues relating to McKessons business and that of its customers and suppliers including pharmaceutical private label products 3PL REMS programs clinical research programs pharmaceutical and medical device distribution Quality Management Systems and compliance marketing authorizations postmarket surveillance advertising and promotion management of manufacturer recalls as well as interaction with regulatory bodies and customers.

Scope of Responsibilities

• Provide legal guidance in preparation for audits and inspections by the FDA and other regulatory authorities and in responding to FDA 483s and enforcement actions developing remediation work plans and conducting market withdrawal/recall/field action analyses.
• Provide legal advice and guidance regarding quality requirements storage and distribution manufacturing premarket approvals and clearances labeling and marketing clinical research adverse event reporting and postmarket actions.
• Provide legal support to corporate compliance in its development and implementation of policies and procedures as well as trainings of sales marketing legal field finance and other personnel on regulatory matters and other relevant topics as well as on investigations and CAPA programs.
• Provide solutionsoriented and strategic legal advice relating to the companys interactions with FDA including crafting legal arguments for inclusion in regulatory submissions and helping teams prepare for formal meetings with FDA and advisory committees and partnering closely with Quality teams to maintain a state of inspection readiness.
• Specific expertise required in statutes regulations and guidance concerning the Federal Food Drug and Cosmetic Act (FDCA) Drug Supply Chain Security Act (DSCSA) Current Good Manufacturing Practices (CGMP) Quality Management System Regulation (QMSR) Modernization of Cosmetics Act (MoCRA) and Good Clinical Practices (GCP).
• Solid working knowledge of other laws regulations and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products including AKS FCPA OIG guidelines and opinions; clinical trial reporting laws Sunshine Act/transparency laws; privacy laws product liability and industry standards (e.g. PhRMA guidelines ICMJE and GPP standards ACCME guidelines).
• In partnership with McKessons Corporate Affairs team provide legal advice to inform and shape advocacy before Congress FDA and other federal and state bodies and agencies with respect to existing and/or emerging regulatory policies.
• Provide legal advice in connection with regulatory due diligence for M&A activities.
• Provide legal advice to sales marketing finance sourcing and procurement and other departments to develop and refine regulatory and legal contract terms.
• Assist in development and periodic refinement of various corporate policies initiatives and/or programs relating to FDA regulatory issues.

Required Knowledge & Skills

• Effective negotiation communication listening and drafting skills including those suitable for interaction with senior managers and executive leadership within a global and matrixed organization and with senior management of key customers.
• Deep expertise in U.S. federal and state healthcare legal and regulatory environments including endtoend support of quality management systems sales and distribution advertising and promotion product claims manufacturing processes.
• An understanding of and fluency with the various healthcare laws and regulations including antikickback laws fraud and abuse statutes and privacy laws applicable to medical device manufacturers and pharmaceutical companies as well as those applicable to their respective customers.
• Demonstrated ability to distill and articulate complex legal concepts into concise and plain English that business partners can both understand and readily act upon.

• Exceptional ability to develop open and candid collaborative working relationships with diverse stakeholders
• Demonstrated ability to influence even without formal decisionmaking authority large crossfunctional teams with varying priorities.
• Strategic and proactive problem solver who anticipates challenges and uses data to develop and drive solutions
• Highly motivated takes ownership and holds self and others accountable
• Demonstrated ability to identify individual business unit tradeoffs to maximize enterprise outcomes
• Cultivates culture of inclusion and trust
• A passionate and engaging communicator to share and generate excitement regarding McKessons FDA compliance program externally and internally
• Excellent external networking and presentation skills including the ability to actively identify appropriate opportunities to share and tailor messages to appropriate audiences
• Thrives in a fastpaced complex and rapidly changing environment
• Highly analytical can synthesize information and offer recommendations/solutions
• Strong financial acumen
• Exemplifies the highest levels of integrity and compliance

Education

• A minimum of 710 years of FDA regulatory legal experience in a wellregarded FDA/healthcare law firm practice at the FDA and/or the inhouse legal department of a leading healthcare company; significant inhouse experience a strong plus especially with a publicly listed company
• U.S. law degree (J.D. required

Other

• Inoffice work required one day per week
• Domestic travel required approximately 510 of the time

Must be authorized to work in the US. Sponsorship is not available for this position.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors including performance experience and skills equity regular job market evaluations and geographical markets. The pay range shown below is aligned with McKessons pay philosophy and pay will always be compliant with any applicable regulations. In addition to base pay other compensation such as an annual bonus or longterm incentive opportunities may be offered. For more information regarding benefits at McKesson pleaseclick here.

Our Base Pay Range for this position

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability age or genetic information. For additional information on McKessons full Equal Employment Opportunity policies visit our Equal Employment Opportunity page.

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