Lead Consultant, Regulatory Affairs

3 weeks ago

Bridgeport, United States Clarivate Analytics US LLC Full time

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

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