Director – IVD Regulatory Consulting

🕒 il y a 28 jours

🇺🇸 États-Unis – Télétravail

💵 $162 000 - $243 000 / an

⏰ Temps Plein

🔴 Expert

🚔 Conformité

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Precision Medicine Group

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2012

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 €35 200 000 Venture Round en 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group est un groupe mondial d’experts spécialisé dans la médecine de précision, qui combine sciences de laboratoire avancées, informatique translationnelle, affaires réglementaires, insights payeurs et communication marketing. L’entreprise se consacre à lever les défis de développement produit et de mise sur le marché pour des clients des secteurs pharmaceutique et des sciences de la vie. Ses services incluent une R&D orientée par les biomarqueurs, ainsi qu’un accompagnement à la commercialisation pour les organisations des sciences de la vie, du lancement jusqu’à la maturité du produit. Precision Medicine Group opère via deux pôles principaux : Precision for Medicine et Precision AQ, spécialisés respectivement dans les solutions cliniques et commerciales.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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