Lead Counsel - Fda And Regulatory

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Lead Counsel - FDA and Regulatory

The candidate will provide legal guidance in preparation for audits and inspections by the FDA, 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 regulations 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 training 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 the FDA, including crafting legal arguments for inclusion in regulatory submissions and helping teams prepare for formal meetings with FDA and advisory committees, partnering closely with quality teams, and maintaining 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). 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 the development and periodic refinement of various corporate policies, initiatives, and/or programs relating to food and drug regulatory issues. 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, and 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. Should have 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 is a strong plus, especially with a publicly-listed company. U.S. law degree (J.D.) required. Should have demonstrated the ability to distill and articulate complex legal concepts into concise and plain English that business partners can both understand and readily act upon. Should have 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. Should have excellent external networking and presentation skills, including the ability to actively identify appropriate opportunities to share and tailor messages to appropriate audiences. Should be highly analytical, can synthesize information, and offer recommendations/solutions. Should have strong financial acumen. Exemplifying the highest levels of integrity and compliance is a must.

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Company info

McKesson Corporation
6535 State Hwy 161
Irving
Texas
United States 75039
Website : http://www.mckesson.com