Vice President, Regulatory Strategy

🕒 Junho 19

🏄 California, Massachusetts – Remoto

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $200.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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Premier Research

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

💰 Venture Round em 2016-10

Healthcare • Consulting • Biotechnology

A Premier Research é uma organização líder em pesquisa clínica focada em apoiar empresas de biotecnologia inovadoras na transformação de ideias que mudam vidas e ciência revolucionária em novos tratamentos médicos. Com capacidades extensivas em pesquisa clínica e desenvolvimento de produtos, a Premier Research oferece um conjunto abrangente de serviços, incluindo consultoria regulatória, estudos do mundo real e de fases tardias, e expertise em diversas áreas terapêuticas, como doenças raras, terapia celular e genética, oncologia, dermatologia e pediatria.

Descrição

• Supervises, mentors, and motivates reporting associates • Develops and implements strategic plans and objectives • Participates in the development of corporate methods, techniques and evaluation criteria • Consults and advises on laws, regulations, and guidelines on clinical trials • Develop and maintain an excellent working relationship with the FDA, EMA and other regulators • Provides leadership in the preparation of regulatory strategies • Provides strategic and tactical guidance to clients • Partners with Business Development to cross-sell Premier’s clinical CRO services • Presents at applicable industry engagements • Performs additional duties and assignments as requested

🎯 Requisitos

• Minimum BS or MS degree in a science-related field • A PharmD or PhD degree is preferred • Minimum of fifteen years regulatory experience in the pharmaceutical, CRO, biotechnology or consulting industry • At least seven years in a management position in a regulatory affairs department • Minimum ten years of experience managing a team • Experience in preparation of regulatory submissions in the US and/or Europe • Experience with supervisory and financial management responsibilities • Experience working in multidisciplinary project teams • Demonstrated skills in complex reasoning, risk management • Excellent written/verbal communication and presentation skills • Excellent interpersonal, motivational and team building skills

🏖️ Benefícios

• health insurance • retirement plans • paid time off