What are the responsibilities and job description for the Lead Counsel - FDA position at MCK McKesson Corporation?

Title : Lead Counsel - FDA

Preferred location : Washington, DC

Other locations : Atlanta, GA; Dallas, TX

Hybrid / Remote / Onsite : Hybrid position

Current Need

M cKesson’s 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 GCO’s mission is :

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 Organization’s 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 McKesson’s FDA-regulated offerings. As an expert in FDA and health-care regulations, 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 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 post-market 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 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 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 McKesson’s 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 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.

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 FDA / healthcare law firm practice, at the 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

In-office work required one day per week

Domestic travel required approximately 5-10% 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 McKesson's 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 long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please

Our Base Pay Range for this position

170,800 - $284,600

Salary : $170,800 - $284,600

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