Compliance Counsel

Location: Emeryville, CA
Department: Legal and Compliance

POSITION SUMMARY

The Compliance Counsel will be responsible for developing, implementing, maintaining, and continuously improving the company’s compliance policies and procedures, as well as guidance consistent with evolving industry standards and codes, risk identification and mitigation strategies, government enforcement priorities, and the growth and development of the company. The role will also support the Compliance Officer in the day-to-day operations and project-based assignments through partnerships with employees and company leadership to maintain and further develop a strong culture of ethics and compliance throughout the organization, including personal accountability at all levels in the organization. 

RESPONSIBILITIES

  • Develops, enhances, and conducts compliance training, drafting and updating policies, reviewing materials and conducting internal monitoring of certain company activities
  • Provides legal advice and counseling on various compliance issues, with a focus on maintaining the company’s compliance with Sunshine Act, Federal/State and OUS reporting requirements for submission to federal, state, and specific OUS country regulatory authorities
  • Provides timely guidance and compliance oversight on company initiatives, such as FMV initiatives related to HCP consulting agreements, advisory boards, speaker programs, sponsorships, grants and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups
  • Develops the annual monitoring & auditing plan, conducts monitoring & auditing, and formalizes findings with corrective action plans.
    • Conducts opening and closing meetings with functional areas.
    • Provides recommendations to senior leadership on risk-based audit initiatives.
  • Drafts and reviews compliance-related materials including policies, procedures, communications, and awareness materials that support the compliance program including publication through internal websites and Compliance Wire
  • Proactively interacts with employees, suppliers and other third parties to communicate the company’s compliance-related obligations and respond to compliance and ethics inquiries, both externally and internally.
  • Identifies policy gaps and opportunities for continuous improvement and training. 
  • Supports the Compliance Officer in preparing meeting agendas and develops content for compliance committee meetings.
  • Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes
  • Supports other strategic compliance initiatives as needed, including in the areas of data privacy, third party risk assessment, export control, sanctions, and anti-corruption.
  • Other duties as assigned.

 

CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS

  • Knowledge of U.S. and foreign compliance and regulatory matters, including healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), Foreign Corrupt Practices Act, privacy laws (e.g., GDPR and CCPA), and US Sunshine Act and OUS transparency laws
  • Certified in Healthcare Compliance (CHC) or similar certification preferred. 
  • Motivated, self-starter with ability to appropriately prioritize issues and allocate resources
  • Ability to work independently and under pressure
  • Demonstrable experience of IT systems to process contracts and manage activity requests, proficiency in Microsoft Office Suite, Microsoft Project, Microsoft Visio, Concur expense reporting
  • Excellent written and verbal communication and interpersonal skills
  • Proven ability to work independently and successfully in multi-functional, matrixed organization
  • Strong problem-solving skills and ability to identify and address complex issues
  • Strong persuasive skills with employees including executive management and sound business judgment
  • Strong task-focused work ethic, including an ability to work to meet deadlines
  • Self-starter who prioritizes well, reacts to opportunities, and instills urgency in others
  • Knowledge and understanding of healthcare compliance issues and ability to act independently on compliance related matters.

 REQUIREMENTS

  • JD (Juris Doctor) degree from a top accredited law school with strong academic credentials
  • 6+ years of legal or Compliance practice experience, Life Sciences/Pharma industry experience strongly preferred

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT

  • Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer usage.
  • Ability to travel when circumstances permit to conduct audits and monitor activities.

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