Guardant Health
Director, Screening Compliance
УдалённоUnited States только· UTC-8…UTC-8
- Опыт
- Синьор
- Занятость
- Полная занятость
- Размер компании
- Крупная
$217.6k–$299.2k/yr
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Коротко по делу
Senior legal/compliance leader for healthcare diagnostics focused on screening compliance. JD + 7+ years advising healthcare orgs or law firms on DHS, Stark, AKS, False Claims and related laws; experience building OIG-style compliance programs. Must be available to work US Pacific Time hours and eligible to work in the USA.
Ключевые навыки
Healthcare compliance
Обязательные навыки
OIG compliance programsFalse Claims ActStark LawEKRAAnti-kickback StatuteAnti-bribery and corruptionClinical laboratory regulationsMedical device regulationsPolicy draftingInternal investigationsRisk assessmentMedicareMedicaid
Желательные навыки
Certification in Healthcare Fraud & Abuse LawKnowledge of coding rules and medical necessityPrivacy laws knowledge
Чем предстоит заниматься
- Provide specialized legal counsel and strategic advice on a wide range of compliance issues to support the development and commercialization of cancer screening test products
- Develop a keen awareness of risks associated with the marketing and sale of cancer diagnostic products to proactively address issues and identify opportunities for process improvements
- Provide guidance with an eye towards problem-solving to business partners and key stakeholders through all stages of the product life cycle
- Draft, implement and maintain relevant policies, procedures, work instructions, and training plans related to risk areas
- Maintain current and accurate knowledge of existing and emerging trends, enforcement actions, industry best practices and laws and regulations regarding healthcare compliance and interactions with healthcare professionals
- Advise on legal issues throughout the medical device lifecycle related to 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, as required, to promote a culture of zero tolerance for non-compliance
- Manage the lifecycle of corrective actions and remediation plans that address compliance-related deficiencies
- Assist with special projects and follow up under the direction of the SVP Legal Affairs & Chief Compliance Officer
Что требуется
- 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
- Experience in a healthcare organization providing legal advice on contractual arrangements with referral sources for designated health services (DHS)
- Specific prior experience in the development/deployment of compliance programs, including all seven elements of the OIG recommended program for clinical laboratories
- Extensive knowledge of federal and state laws (False claims act, Starks Law, EKRA, Antikickback statute, anti-bribery and corruption) and industry requirements for the diagnostics/device laws
- Experience implementing suitable policies tailored for compliance with these laws
- Proven track record in driving awareness and deploying risk mitigation strategies
- 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
- Demonstrated ability to advise and collaborate with business leaders and key stakeholders on compliance issues
- Training and presentation experience in various settings including live audience and video conferencing
- Excellent verbal and written communication skills
- Ability to travel, on occasion (~15%)
Преимущества
- Hybrid Work Model with defined in-person days for employees within 50 miles of a Guardant facility
- Guardant Health provides reasonable accommodations in hiring processes
- Background screening required; consideration consistent with applicable Fair Chance policies
- Equal Opportunity Employer policies
- Opportunity to follow company on LinkedIn, X (Twitter) and Facebook
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics.
$217.6k–$299.2k/yr