Director, Screening Compliance

🕒 Junho 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $217.600 - $299.200 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 45%

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Guardant Health

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

A Guardant Health é uma empresa de oncologia de precisão que se especializa no uso de exames de sangue para revolucionar o tratamento do câncer. Seus testes inovadores fornecem insights críticos que ajudam a informar as decisões de tratamento para pacientes em todos os estágios do câncer. Ao alavancar tecnologia avançada e dados, a Guardant Health busca melhorar os resultados clínicos e aprimorar a experiência geral do paciente na luta contra o câncer.

Descrição

• Provide specialized legal counsel and strategic advice on compliance issues supporting development and commercialization of cancer screening test products • Develop awareness of risks associated with marketing and sale of cancer diagnostic products and identify process improvement opportunities • Guide business partners and key stakeholders through all stages of the product life cycle • Draft, implement, and maintain policies, procedures, work instructions, and training plans related to risk areas • Maintain current knowledge of trends, enforcement actions, industry best practices, laws, and regulations regarding healthcare compliance and healthcare professional interactions • Advise on legal issues throughout the medical device lifecycle, including clinical research, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, patient access, and financial assistance programs • Review promotional and educational materials as part of a cross-functional team • Perform routine teaching audits of high-risk functional areas to assess and improve training effectiveness • Assist with internal investigations and timely follow-up on inquiries and complaints • Manage corrective actions and remediation plans addressing compliance-related deficiencies • Assist with special projects and follow-up under the direction of the SVP Legal Affairs & Chief Compliance Officer

🎯 Requisitos

• J.D. with a minimum of 7 years of progressively responsible experience in a legal department of a healthcare organization and/or law firm setting • Certification in Healthcare Fraud & Abuse Law Compliance preferred • Working knowledge of clinical laboratory, diagnostic, and medical device industries and designated health services and enforcement of associated federal and state regulations • Strong research, analytical and problem-solving skills • Knowledge of Medicare, Medicaid requirements, medical necessity and coding rules and guidelines preferred • Demonstrated ability to advise and collaborate with business leaders and key stakeholders on compliance issues, facilitating risk assessment and developing practical business solutions • Training and presentation experience in various settings including live audience and video conferencing • Excellent strategic and analytical skills with the ability to help business partners identify compliant solutions to novel issues • Ability to articulate risk without being an “alarmist” • Excellent verbal and written communication skills • Knowledge of privacy laws (federal and state laws) a plus • Ability to travel, on occasion (~15%) • Experience providing legal advice on contractual arrangements with referral sources for designated health services • Experience developing and deploying compliance programs, including all seven elements of the OIG-recommended program for clinical laboratories • Extensive knowledge of federal and state laws, including False Claims Act, Stark Law, EKRA, Anti-Kickback Statute, and anti-bribery and corruption laws • Experience implementing suitable compliance policies tailored to healthcare diagnostics/device laws and requirements • Solid understanding of ethics and compliance risk best practices within the healthcare diagnostics industry • Proven track record driving awareness and deploying risk mitigation strategies • Availability to work during U.S. Pacific Time zone working hours • Background screening including criminal history required • Ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements

🏖️ Benefícios

• Base salary range of $217,600–$299,200 for the primary and other U.S. locations • Colorado base salary range of $230,400–$316,800 • Hybrid work model with designated in-person collaboration days and work-from-home days for eligible onsite employees • Reasonable accommodations for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs