Senior Manager, Compliance Operations

Vaga não está no LinkedIn

🕒 Outubro 30

🏄 California – Remoto

🏄 California – Remote

💵 $185.000 - $200.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 4%

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• Aberta há 11 dias.

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Belite Bio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2018

🧬 Biotecnologia

💊 Farmacêutico

🔥 Investimento no último ano

💰 $402.000.000 Post-IPO Equity em 2025-12

Biotechnology • Pharmaceuticals

A Belite Bio é uma empresa biofarmacêutica em estágio clínico que desenvolve terapias inovadoras com base em seu portfólio de propriedade intelectual relacionado à RBP4 (Retinol Binding Protein 4). Seu principal candidato, o tinlarebant (LBS-008), é uma terapia oral desenvolvida para reduzir o acúmulo de substâncias tóxicas nos olhos e está sendo desenvolvido para doenças degenerativas da retina, incluindo a doença de Stargardt autossômica recessiva (STGD1) e a atrofia geográfica (degeneração macular relacionada à idade do tipo seca em estágio avançado). A Belite Bio está conduzindo múltiplos estudos clínicos — incluindo programas de Fase 1b/2, Fase 2/3 e Fase 3, como DRAGON, DRAGON II e PHOENIX — e o tinlarebant recebeu diversas designações regulatórias (Orphan Drug nos EUA, na União Europeia e no Japão; Rare Pediatric Disease; Breakthrough Therapy; Fast Track; e Sakigake). O pipeline da empresa também inclui programas voltados ao tratamento de doenças metabólicas e hepáticas, como a doença hepática gordurosa não alcoólica e o diabetes tipo 2.

Descrição

• Administer and own the Company’s Learning Management System, including user access, role-based curricula, course assignments, completion tracking, escalation processes, and training records • Coordinate with Compliance, Legal, Human Resources, Information Technology, Quality, Commercial, Medical, and functional leaders on training requirements and training matrices • Manage LMS workflows, reports, dashboards, and metrics for completion, overdue training, recurring assignments, new-hire training, targeted training, and remediation training • Maintain accurate, complete, and audit-ready training records and documentation • Support development, upload, testing, deployment, version control, retirement, and archival of LMS training content • Improve LMS user experience, administration, data integrity, automation, and operational controls • Prepare regular LMS status reports, key performance indicators, training trends, overdue items, and follow-up insights for leadership • Maintain the Compliance policy and procedure inventory, including lifecycle tracking, review schedules, version control, approvals, publication, acknowledgments, retirement, and archival • Coordinate policy approval workflows with policy owners, reviewers, approvers, Legal, Compliance leadership, and other stakeholders • Ensure policies, procedures, and related documents are formatted, current, accessible, and aligned with applicable requirements • Track policy acknowledgments and training requirements and follow up on overdue items • Support third-party compliance processes, including due diligence documentation, screening, training assignment, record maintenance, risk-based follow-up, and monitoring • Assist with auditing and monitoring support, State and Federal transparency-law reporting obligations, price transparency requirements, and other Compliance activities

🎯 Requisitos

• Bachelor’s degree required; degree in Business, Life Sciences, Healthcare Administration, Legal Studies, Compliance, Information Systems, or related field preferred • Minimum of 5 years of experience in pharmaceutical, biotechnology, healthcare, or life sciences compliance • Significant experience in compliance operations, training operations, policy management, third-party compliance, or compliance systems administration • Experience administering or serving as business owner for an LMS or related compliance technology platform required • Knowledge of U.S. laws, regulations, and industry guidance relevant to pharmaceutical compliance programs • Experience with healthcare fraud and abuse laws, federal and state anti-kickback statutes, PhRMA Code, FDA regulations concerning promotional activity, and government agency guidance and enforcement activity • Experience managing or administering an LMS, compliance training platform, policy management system, case management tool, third-party compliance platform, or similar enterprise compliance system • Strong understanding of compliance operations, training governance, records management, policy lifecycle management, approval workflows, hotline administration, third-party compliance processes, and audit-ready documentation • Strong project management, organizational, analytical, and process-improvement skills • Strong systems aptitude and ability to learn, administer, troubleshoot, document, and improve technology-enabled compliance processes • Exceptional attention to detail and documentation discipline • Excellent verbal and written communication skills • Ability to manage multiple operational workstreams, deadlines, stakeholders, and system-related priorities • Ability to work accurately with an appropriate sense of urgency in a fast-paced and dynamic environment • Strong interpersonal skills, diplomacy, flexibility, and collaboration • 10-20% travel may be required based on business needs

🏖️ Benefícios

• Annual incentive bonuses • Equity participation • Health insurance • Dental insurance • Vision insurance • 401(k) • Paid time off

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