Description:

Summary
The Attorney - Healthcare Law will play an important role in Arcus’s growth. Reporting to the Head of Compliance, this individual will be responsible for ensuring the company’s approach to managing its operations evolves appropriately through clinical development to product launch and commercialization. The role requires cross-functional collaboration, independence, and initiative to develop and optimize processes to support the company through its late-phase development activities and prepare for potential commercialization.

Responsibilities
  • Manage and own the company’s communications review process, working closely with Medical Affairs, Regulatory, Commercial, Corporate Communications, and Clinical Operations; provide prompt review and guidance for materials managed through that process
  • Provide guidance and support to transactional attorneys to manage risks associated with third-party engagements, including HCP engagements; support tracking and monitoring of HCP engagements, including for U.S. and ex-U.S. Sunshine Act reporting
  • Act as a strategic business partner to Medical Affairs, Commercial, Market Access, Clinical, and Quality colleagues in developing creative and thoughtful solutions to meet company initiatives considering the legal and regulatory landscape, including the requirements and expectations of the United States Food and Drug Administration and foreign equivalents
  • Maintain an understanding of relevant laws, regulations, guidelines, and industry guidance documents, as well as applicable government priorities and enforcement trends that might impact company plans
  • Develop training materials, tools, and other internal resources to facilitate understanding of and compliance with legal and regulatory landscape
  • Consider and suggest enhancements to company policies, procedures, and controls to support compliance with relevant laws and regulations

Qualifications
  • Juris Doctor (JD) required
  • All candidates must be in good standing with the local state bar in the state in which they reside and are licensed
  • 5+ years of experience in the legal function of a biopharmaceutical company and/or a healthcare compliance practice of a nationally recognized law firm, including experience with review of promotional and non-promotional communications materials required
  • Specific knowledge of and experience with FDA regulations and foreign equivalents, fraud and abuse and anti-kickback laws, and anti-bribery and corruption laws; desire to learn about new and changing U.S. and international healthcare laws and regulations
  • Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions to satisfy both business requirements and legal obligations
  • Strong knowledge of laws and regulations impacting manufacturers engaged in the development and commercialization of pharmaceutical products
  • Excellent judgment in assessing the risks posed by various activities as well as the potential impact of such risks on the company
  • Interest in building and optimizing tools and processes
  • Experience with PromoMats or other similar review committee platform, and comfort leading committee activities through that platform
  • Ability to appropriately prioritize within a changing environment, recognizing and responding quickly and pragmatically to urgent situations
  • Ability to work independently while meeting aggressive deadlines and juggling complex matters
  • Process oriented with attention to detail, strong analytical thinking, and data analysis skills
  • Excellent verbal and written communication skills

This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - $230,000. For remote-based candidates, the salary range may vary based on local market data. Factors such as relevant experience, education, duration of experience, and length of industry experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers/.