Lead Counsel - FDA & Regulatory at McKesson

Lead Counsel - FDA & Regulatory Counsel

Washington, DC or Dallas (Las Colinas), Texas (REQUIRED)

Current Need

McKesson seeks a Lead Counsel to provide strategic legal advice on matters related to Food & Drug Administration (FDA) Quality Management Systems and regulations. Reporting to the VP, Assistant General Counsel, the Lead Counsel will work closely with the legal, compliance, and operational teams supporting our North American business units on the full portfolio of McKesson’s FDA-regulated offerings. As an expert in his/her field, the Lead Counsel will be particularly engaged on issues relating to McKesson’s 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, post-market 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 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 FDA regulations including regulation relating to Product Clearances; development strategies, including with respect to clinical trial design and regulatory pathways; regulatory strategy and pre-market applications (including for digital health and other combination products); premarket notifications, including 510(k)s and PMAs; manufacturing; post-market (including any product modifications) and product end-of life. Provide counseling in connection with post-market reporting, including MDR reporting, field corrective actions, CAPA, complaint handling and similar matters.
• Advise on legal questions relating to sunshine reporting and clinical trial transparency initiatives (e.g., clinicaltrials.gov and EudraCT requirements, researcher requests for clinical trial data, Policy 0070, provision of plain language summaries under EU Clinical Trial Regulation)
• Actively advise business partners and other attorneys regarding physician self-referral law (Stark); health care services reimbursement and value-based purchasing; and related topics.
• 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 solutions-oriented and strategic legal advice relating to the company’s 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, maintain a state of inspection readiness.
• Advise on issues related to FDA’s expedited programs for serious conditions, such as accelerated approval, fast track designation, breakthrough designation, priority review, as well as on exclusivity issues
• Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, promotion and scientific exchange, Hatch-Waxman, compassionate use, Orphan Drug Act, and DQSA.
• 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 McKesson’s Public 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 food and drug 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 end-to-end 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 anti-kickback 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 decision-making authority, large cross-functional teams with varying priorities.
• Ability to lead and rally teams around what matters, including during times of significant transformation
• Skilled at cultivating talent; invests in self and growing others
• 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 McKesson’s 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 fast-paced, 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 7-10+ years of FDA regulatory legal experience in a well-regarded healthcare-recognized law firm, in FDA and/or the in-house legal department of a leading healthcare company; significant in-house experience a strong plus, especially with a publicly-listed company.
• U.S. law degree (J.D.) required.

Other

• Domestic travel required approximately 5-10% of the time.

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

$169,700 - $282,800

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to [email protected]. Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

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