Regulatory and Commercial Counsel

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Fast growing publicly traded pharmaceutical company in New York is seeking an experienced regulatory and commercial lawyer to join its ┬áRegulatory and Commercial Law team. In this role you will provide proactive and collaborative legal support in connection one or more of the company’s products and will act as a legal advisor to the company’s sales, marketing, medical affairs, regulatory, and compliance teams. The role will counsel internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues.

As a Corporate Counsel, a typical day may include:

  • Providing product support counseling for one or more products/product candidates from development through commercialization and lifecycle planning
  • Counseling on launch preparation activities for product candidates
  • Advising on brand-related strategic planning and business operating plans
  • Reviewing and approving external communications and educational materials about products
  • Advising on FDA regulatory submissions and product labeling discussions
  • Providing day-to-day strategic counseling on a broad range of healthcare regulatory matters, including advertising and promotion, privacy, drug safety, market research, scientific exchange, interactions with healthcare professionals, market access, patient support programs, and external funding requests.
  • Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements.
  • Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development.

This role might be for you if you:

  • Have outstanding interpersonal and conflict resolution skills
  • Work well independently, while meeting aggressive deadlines and prioritizing multiple matters
  • Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions
  • Have exceptional oral and written communication skills
  • Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting the company’s interests
  • Work effectively and expertly with colleagues & clients in a collaborative environment
  • Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures

To be considered for this position, you must:

Possess a solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. Have a JD with excellent law school credentials and be licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. Have at least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience.

Competitive compensation. Bonus and equity eligible position.

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