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Senior Regulatory Counsel - Varian Medical Systems

Company: The San Mateo County Bar Association
Location: Washington
Posted on: July 9, 2024

Job Description:

Senior Regulatory Counsel - Varian Medical SystemsWhen you join Varian, you're joining an organization with nearly $3 billion in annual revenue, and more than 6,500 team members across more than 30 countries. You'll be backed by a culture that is centered on fostering your creative potential, and experience the full support of an organization and leadership committed to inspiring you to do your best work. Together, we can make an impact on our customers, each other, and millions of lives. At Varian, you'll find yourself surrounded by some of the world's best and most creative talent, working together with a singular goal - our mission to help save lives. Our technology helps clinicians fight cancer, and the work you will do can support this important goal. Whether your focus is Legal, Human Resources, Government Affairs, Finance or IT, joining our Corporate Services team means you'll contribute to Varian's success as a global cancer fighter around the globe.Job DescriptionVarian Medical Systems, a Fortune 1000 company, whose leading technology, products and software are being used in the fight against cancer, is seeking an experienced and self-motivated attorney with 7+ years of Regulatory experience in advising the health care industry to join its legal team. This position may be based in our offices in Atlanta, Washington D.C. or Palo Alto.Roles and ResponsibilitiesProvide legal guidance and support on a wide range of regulatory and medical affairs matters, including but not limited to pre-market approvals, submissions and responses to the FDA, quality systems, commercialization, advertising, promotions, marketing, communications and labeling for on-label and off label products, new product introductions and revenue models, post-surveillance, inspections, deficiency/warning letters and/or recalls.Serve on Varian's Promotional Review Committee and Medical Affairs Committee.Counsel internal clients on a variety of regulations and policy initiatives, including the FDA, Stark, open-payments, anti-kickback, anti-bribery, fraud and abuse, HITECH and HIPAA.Independently negotiate, document and close speaker, clinical research and clinical trial agreements.Conduct due diligence review of FDA regulated companies related to M&A.Identify risks and come up with practical, results oriented alternatives to mitigate risk.Collaborate with cross-functional teams and executives from regulatory, medical affairs, the business units, marketing, ethical compliance, sales, service, support and operationsDrive and project manage legal projects and conduct training to the regulatory, medical affairs, sales and marketing teams.Provide over-flow support on sales and commercial transactions.Job RequirementsExperience providing legal advice for a wide range of regulatory matters, including, but not limited to reviewing and providing guidance on submissions, supplemental filings and responses to the FDA and other related governmental agencies, off-label and on-label products and services, pre-market approvals, marketing and promotional collateral, and labelling, new product introductions, post-surveillance matters such as inspections, deficiency/warning letters and/or recalls.Experience giving guidance in enhancing, designing and implementing programs and policies pertaining to a variety of regulations, including, but not limited to the FDA, Stark, anti-kickback, anti-bribery, fraud and abuse, HITECH Act, HIPAA and other privacy laws.Served on either a promotional review or medical affairs committee.Has independently negotiated, documented and closed speaker, clinical research, clinical trial, and commercial agreements.Ability to identify risks, draft contract provisions and advise internal clients on alternative ways to mitigate risk.Excellent communication skills and ability to collaborate with cross-functional teams and executives from regulatory, medical affairs, marketing, sales, support and their operational teams.Must be practical, results oriented, well-organized, detail-oriented, with a proven ability to independently counsel and maintain internal client relationships.7+ years of regulatory experience in the health care or medical device industry.Can do attitude who is willing to take on any matter or project whether large, small, complex, simple, and/or novel.Proven ability to think clearly and succinctly and cogently articulate a negotiating position as well as draft contracts in clear, concise language.Able to thrive in a fast-paced environment and successfully manage multiple deadlines.Be a team player who can perform assigned responsibilities with minimal supervision.Juris Doctor degree from a U.S. accredited law school.Licensed to practice law in either California, Georgia or Washington D.C.Experience working in the oncology or medical device industry a plus. Morgan Lewis, One Market, Spear St. Tower Asian American Bar Association of the Greater Bay Area
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Keywords: The San Mateo County Bar Association, Washington DC , Senior Regulatory Counsel - Varian Medical Systems, Accounting, Auditing , Washington, DC

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