Director, Screening Compliance

🕒 vor 4 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $217.600 - $299.200 / Jahr

⏰ Vollzeit

🔴 Experte

🚔 Compliance

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

👻 Geisterscore 45%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Guardant Health

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2012

🏥 Gesundheitswesen

💼 Beratung

🍽️ Lebensmittel & Getränke

Healthcare • Consulting • Food & Beverage

Guardant Health ist ein Unternehmen für Präzisionsonkologie, das sich auf die Nutzung von Bluttests zur Revolutionierung der Krebsbehandlung spezialisiert hat. Ihre innovativen Tests liefern entscheidende Erkenntnisse, die dazu beitragen, Behandlungsentscheidungen für Patienten in allen Stadien des Krebses zu treffen. Durch den Einsatz fortschrittlicher Technologien und Daten strebt Guardant Health danach, die klinischen Ergebnisse zu verbessern und das gesamte Patientenerlebnis im Kampf gegen den Krebs zu optimieren.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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