Senior Corporate Counsel - Healthcare Law
Pharmacyclics, Inc. - Sunnyvale, CA

This job posting is no longer available on Pharmacyclics, Inc.. Find similar jobs: Senior Corporate Counsel jobs - Pharmacyclics jobs

The Senior Corporate Counsel - Healthcare Law will work as part of the small but rapidly growing Legal department of Pharmacyclics. The position will report directly to the head of the Legal department. The successful candidate will counsel senior sales, marketing, medical affairs, regulatory and other internal clients on compliance with federal and state laws and regulations related to the sales and marketing of human medicines and companion diagnostics. The Counsel’s responsibilities will include, but not be limited to:
  • Serving as lead healthcare counsel for commercial product launch and brand management teams
  • Reviewing medical informational materials and programs, investigator sponsored research proposals, investigator grants, patient foundation grants, early access programs, and medical science liaison (MSL) materials and programs for compliance with federal and state laws and regulations
  • Serving as lead counsel to the Medical Review Committee of Pharmacyclics
  • Reviewing advertising and promotional materials, campaigns and programs for compliance with federal and state laws and regulations
  • Serving as lead counsel to the Promotional Review Committee of Pharmacyclics
  • Advising on appropriate company relationships with patients, patient advocate groups, healthcare providers, healthcare institutions, and government entities
  • Counseling and providing guidance on compliance with FDA post-marketing requirements
  • Supporting Commercial Operations, Sales Training, MSL Training, Managed Markets, Patient Services and related project teams
  • Interpreting company policies and educating internal clients and colleagues about enforcement trends and discrete legal issues

Experience and Qualifications
  • JD with Bar admission and between 7-10 years in practice
  • 5+ years of recent relevant legal experience in a top tier law firm’s FDA / Life Sciences practice or pharmaceutical or biotechnology company’s law department
  • Focus on counseling pharmaceutical sales, marketing, regulatory and medical affairs clients on state and federal requirements relating to the sales and marketing of pharmaceutical products required
  • Must have significant knowledge of government enforcement trends, the Federal Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute and laws related to Medicare/Medicaid fraud and abuse
  • Outstanding regulatory technical expertise with respect to drug advertising and promotion
  • Prior success in learning and reaching increasing levels of competency in a law department that values ongoing professional development and collegiality
  • Consistent demonstration of excellent judgment, communication, collaboration, and interpersonal skills
  • Must be passionate about his/her role as a proactive, strategic, solutions-oriented, client-focused, ethical counselor who helps drive business excellence to improve patient lives