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    Lead Consultant, Regulatory Affairs - Frankfort, United States - Clarivate Analytics

    Clarivate Analytics
    Clarivate Analytics Frankfort, United States

    3 weeks ago

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    Description
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    Lead Consultant, Regulatory Affairs

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    locations

    Remote (130- New Jersey)

    Remote (106- Connecticut)

    time type

    Full time

    posted on

    Posted 12 Days Ago

    job requisition id

    JREQ126575

    Clarivate is a leading global provider of transformative intelligence.

    We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare.

    Our connected data, deep expertise and intelligence platforms empower life sciences and healthcare companies to deliver safe, effective and commercially successful treatments to patients faster.

    Clarivate is home to Cortellis, solutions for real world data, medtech, market access and commercialization and deep consulting expertise.
    We help companies advance their drug discovery, preclinical proof-of-concept, and regulatory activities.

    Clarivate's translational science expertise, skilled teams of regulatory and commercial experts and assets such as the Centre for Medicine Research (CMR) combine to offer a highly reputable source of pharmaceutical industry metrics and insights.

    By providing perspective, data and insights across the development spectrum, we complement client teams in generating long term value.
    Our Regulatory & Clinical Consulting Services team in US is looking for a Lead Consultant.
    This position can be performed near any US Clarivate office or fully remote

    Responsibilities of this role include:
    Business development (30%)
    Provides responses to any received RFI and RFPs.

    Holding scoping discussions with customers to ensure Clarivate Analytics have a robust understanding of a customer's needs and requirements for any given project.

    Working with Consulting services colleagues to provide robust effort estimates for scoped projects.
    Drafting customer facing materials to support proposals and service request forms.

    Build a sustainable pipeline of services offerings and projects by identifying clients, understanding client requirements, and delivering unique solutions to each client ask.

    Communicates services offerings of the practice area, in RFP responses, and in support of individual opportunities to sales and to customers.

    Develops case studies that describe practice area offerings and ensure those case studies are communicated and accessible.

    Participates in opportunity development, to architect solutions and support the planning of consulting service projects from inception to contract closing.

    Supports proof of concept deliverables to demonstrate technical proof during sales process.
    Coaching of Presales Solutions Specialists to increase their knowledge of Regulatory Services to support presales discussions
    Project Delivery Support (70%)
    Become an integral member of the customer facing team of the Life Sciences Consulting Services team.

    Act as the primary point of contact for the customer throughout a project's lifecycle to ensure a high quality of service and deliverables.

    Act as the project manager for regulatory consulting services to ensure successful and timely delivery of each assigned project.
    Co-ordinate resources across the R&C Practice and potentially third party vendors to ensure the successful delivery of relevant projects.
    Escalates any project risks and delivery issues to the R&C Consulting Director for action and resolution.

    Supports and delivers proof of concept solutions to validate the understanding between the proposed solution and customer needs identified during the sales process.

    Collaborates with other Life Sciences Consulting Services teams to meet the client needs by employing the Clarivate Analytics suite of databases and Enabling Technology solutions.


    Qualifications and Experience:
    Master's Degree in life sciences

    A minimum of 10 years' experience in Pharmaceutical Regulatory Affairs/Regulatory Intelligence across major markets (Europe, North America, Asia Pacific) in Life Science industry and/or in consulting companies.

    Experience in supporting Regulatory services from conception to delivery in a customer facing role, preferably within a consulting service provider.


    Knowledge and skills:
    Expert knowledge in key areas of responsibility e.g. operating systems, networking technologies, technical standards
    Expert knowledge of relevant markets from a regulatory/clinical perspective
    Excellent customer facing skills
    Strong problem management, troubleshooting and analytical skills
    Demonstrated ability to work with and manage virtual teams to successfully deliver projects
    Demonstrated ability to learn and understand internal systems and processes
    Able to work well in a demanding and changing environment
    Independent worker with excellent time management skills

    Travel:
    infrequent travel may be required.
    Clarivate is an Equal Opportunity Employer

    Vets/Minorities/Women/Disabled

    About Us

    Clarivate is a global leader in providing solutions to accelerate the lifecycle of innovation.

    Our bold mission is to help customers solve some of the world's most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property.

    We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise.

    For more information, please visit

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