Director – IVD Regulatory Consulting

🕒 Maio 27

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $162.000 - $243.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Precision Medicine Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $35.200.000 Venture Round em 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Precision Medicine Group é uma equipe global de especialistas dedicada à medicina de precisão, que combina ciências laboratoriais avançadas, informática translacional, assuntos regulatórios, insights de pagadores e comunicações de marketing. A empresa foca em superar desafios de desenvolvimento de produtos e de comercialização para clientes dos setores farmacêutico e de ciências da vida. Seus serviços incluem P&D orientada por biomarcadores, bem como suporte à comercialização para organizações de ciências da vida, do lançamento à maturidade do produto. A Precision Medicine Group opera por meio de duas frentes principais: Precision for Medicine e Precision AQ, especializadas em soluções clínicas e comerciais, respectivamente.

Descrição

• Responsible for applying extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions. • Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics • Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients • Review and direct the development of analytical and clinical protocols, technical reports and other company documents for use in regulatory submissions and in response to queries from regulatory agencies • Identify and collaborate with external thought-leaders and technical experts required to support research and development • Manage, motivate, and develop staff to ensure a scalable model within the Regulatory practice as a whole

🎯 Requisitos

• Bachelor’s degree in Life Sciences or equivalent work experience • Minimum 5 years of applicable consulting experience with a focus in regulatory affairs • Minimum of 7 years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment • Strong written and verbal communication skills • Strong leadership, team building and interpersonal skills • Strong business and financial acumen • Strong scientific and analytical skills • Ability to think outside of the box and solve difficult problems with effective solutions • Direct experience working with small and large companies to design global regulatory and commercialization strategies • Experience managing staff members and project teams

🏖️ Benefícios

• discretionary annual bonus • health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation