Lead Consultant, Regulatory Affairs - Clarivate

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