Director, IVD Regulatory Consulting

🕒 il y a 28 jours

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Precision For Medicine

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 €75 000 000 Private Equity Round en 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision for Medicine est un leader spécialisé dans l’accompagnement du développement et de la mise sur le marché de thérapies innovantes, notamment en oncologie, dans les maladies rares et les maladies auto-immunes. Grâce à une gamme complète de services — gestion d’essais cliniques, services de laboratoire et collecte de biospécimens — l’entreprise intègre des capacités avancées en biomarqueurs ainsi que des solutions de fabrication pour fluidifier des processus de développement clinique complexes. Sa mission est d’accélérer la recherche et d’apporter aux patients des solutions médicales qui changent la vie, en dépassant les inefficacités traditionnelles souvent observées dans le paysage du développement pharmaceutique.

Description

• 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 • Identify and collaborate with external thought-leaders and technical experts required to support research and development • Review and edit regulatory communication, submission, timeline and approval requirement documents • Apply quality systems expertise to guide clients towards successful readiness to market products • Generate new business through your own network • Work in conjunction with management to design and develop customized program recommendations • Lead workshops and conference curriculums in regulatory science for in vitro diagnostics • Advise on work orders, change orders, master service agreements and other documents • Collaborate with business development account management team

🎯 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

• Annual discretionary bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation