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Senior Counsel, Healthcare Law

General CounselGeneral CounselFull TimeRemoteTeam 11-50Since 2021Company SiteLinkedIn

Location

California

Posted

19 days ago

Salary

Not specified

Professional Certificate8 yrs expEnglish

Job Description

• Providing advice, education, training and legal direction on, healthcare fraud and abuse laws, pricing, FDA labeling and promotional matters, clinical research, healthcare compliance, products liability, antitrust, privacy and other laws impacting the commercialization of biotech products; • Serving as key member of Arcutis promotional review committees; • Drafting, reviewing, and negotiating a wide range of contracts in support of product development and commercialization (which may include confidentiality agreements, consulting agreements, materials transfer agreements, clinical trial agreements, and various other agreements); • Provide legal counsel for product lifecycle and cross-functional product teams and initiatives; • Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies; • Advising regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; • Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, organized customers, and government entities; • Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance, and on current enforcement trends; • Interacting with senior executives to provide legal advice.

Job Requirements

  • Law degree and licensed to practice law in one or more jurisdictions.
  • 8 or more years of related experience as healthcare law counsel a company, law firm, and/or government (e.g., OIG, DOJ, CMS or FDA).
  • Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the life science industries.
  • In-house experience is preferred.
  • Ability to work in a fast-paced, dynamic environment with little supervision
  • Ability to solve complex problems
  • Strong cross-functional collaboration skills
  • Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner
  • Demonstrated enterprise and growth mindset
  • Ability to establish and maintain good working relationships with personnel and to handle confidential information sensitively and discreetly
  • Strong verbal and written communication skills, including communicating complex legal issues in a digestible manner for internal clients
  • Strong attention to detail
  • Proficient in the use of business productivity software (Word, PowerPoint, Excel, etc.)

Benefits

  • Travel to the corporate office may be required up to 20% of time worked

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