Director, IVD Regulatory Consulting

🕒 Maio 27

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $75.000.000 Private Equity Round em 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• 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

🎯 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

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