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Senior Clinical Trial Expert (Regulatory) - Multiple European Locations (R1038874) in Copenhagen Ø, Denmark at IQVIA™

Date Posted: 4/13/2019

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Job Description

Senior Clinical Trial Expert (Regulatory) to join an expanding team of senior experts in Tarius (on-line platform) .

Your role:

You will join a dedicated and experienced team of senior regulatory experts who together with the Content Manager are responsible for the high quality regulatory content of the Database. In your role you will be responsible for the development of new content offerings within the Clinical Trial area working as part of the offering development projects on an on-going basis. As we are expanding the scope and improving the Clinical Trial information our offering as well as adding impact assessments, you are responsible for creating Clinical Trial intelligence content and insights of value to our customers. You will also be responsible for the on-going maintenance of Clinical Trial content in our offering. This includes the overall responsibility for the Clinical Trial regulatory content within Tarius as well as the Cross-Country Tables and Expert Summaries across all countries. You will succeed with this part of the role by collaboration with our local experts. As our Senior Clinical Trial expert you will be responsible for ensuring knowledge-sharing across the Tarius team on appropriate topics as well as establishing a network to other Clinical Trial experts in other parts of IQVIA.

The team is based in Copenhagen but it is not required for you to work out of Copenhagen.

Overview of Team

The senior Clinical Trial expert will be joining an expanding team of senior regulatory experts who together with the content manager are responsible for the high quality regulatory content of the Database. The expert team is supported by a Global Network of Regulatory Experts consisting of more than 300 senior regulatory experts based worldwide. The local experts review and update information from their respective countries, providing their knowledge about local best practices and interpretation of the national regulations. In addition, the expert team works closely with the Multilingual Editorial Team, responsible for updating Tarius’ online information database.

Key Responsibilities

  • Drives the clinical trial content work in offering development projects expanding and improving the quality of the clinical trial regulatory content
  • Owns (in partnership with the content manager) the clinical trial regulatory content in Tarius including the relevant expert summaries and cross country tables covering all countries
  • Responsible for ensuring the content quality standards are met at all times
  • Responsible for providing high-quality impact assessment of key regulatory documents EU and US
  • Collaborates with Local experts and Tarius Editorial Team on aspects related to the clinical trial regulatory content
  • Responsible for knowledge-sharing and training within the clinical trial regulatory area
  • May participate in client meetings as subject matter expert on the clinical trial regulatory content

Required Knowledge, Skills and Abilities

  • +10 years of experience within clinical regulatory area (preferably from pharmaceutical company)
  • In-depth knowledge on clinical trial regulatory including:
    • Requirements in all phases of drug development (phase I-IV studies)
    • Clinical trial applications and ethics committees
    • Regulatory processes and approval times
    • Knowledge on clinical trial registries and results disclosed
    • Ability to assess impact of new regulatory requirements EU and US
  • Master’s degree or equivalent
  • Excellent English skills
  • Experience in working in a project setting
  • Knowledge of the pharmaceutical industry and/or medical device industry and its challenges
  • Business understanding/acumen
  • Ability to create strong working relationships across organisation (local experts, editors, consultants and external partners)

Job ID: R1038874