R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. As one of our former FDA colleagues highlights: "You get to work at the forefront of innovation. Working side by side with clients to accelerate therapies that can change patients' lives." If you're looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there's no better place to be than as a Senior / Vice President, Technical on Parexel 's Regulatory Strategy team (RS)! As a Sr/VP, Tech you'll work on a variety of assignments, diverse product types for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home. As a critical member of Parexel's Regulatory Strategy team, you'll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory, and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators' requirements. You'll be meeting new situations and learning all the time. In fact, one of the key characteristics you'll see in our Sr/VP Techs is innate curiosity along with a passion for the science, the industry, and public health. You'll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers. And, if you're not already, you'll soon certainly become a visible figure in the industry. If you're committed to public health and want to make a difference, this is the ideal role. We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A Senior/Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior/Vice President Technical must have a thorough understanding of the organization's consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior/Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies. Project Execution Works within a team environment or individually based on the project needs Works within broad project guidelines and leads issue and conflict resolutions Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met Manages project engagements (small or large) Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support Provides guidance to project team members and acts as a mentor to junior staff Thought Leadership Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met Regularly quoted by general and industry news outlets When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise Reinforces the knowledge-centered activities within RS based on their own knowl

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