Senior Manufacturing Expert - Multiple European Locations (R1040358) in Frankfurt/Main, DE at IQVIA™

Date Posted: 2/16/2020

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Job Description

Senior CMC/Manufacturing Expert 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 CMC/Manufacturing area working as part of the offering development projects on an on-going basis. As we are expanding the scope and improving the CMC/ Manufacturing information our offering as well as adding impact assessments, you are responsible for creating CMC/Manufacturing intelligence content and insights of value to our customers. You will also be responsible for the on-going maintenance of CMC/Manufacturing content in our offering. This includes the overall responsibility for the CMC/Manufacturing 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 CMC/Manufacturing expert you will be responsible for ensuring knowledge-sharing across the Tarius team on appropriate topics as well as establishing a network to other CMC/Manufacturing 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 CMC/Manufacturing 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 Quality/CMC content work in offering development projects expanding and improving the quality of the applicable regulatory content
  • Owns (in partnership with the content manager) the Quality/CMC 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 CMC content
  • Responsible for knowledge-sharing and training within the CMC 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 manufacturing regulatory area (preferably from pharmaceutical company)
  • In-depth knowledge on Quality/CMC regulatory including:
    • Requirements in all phases of drug development (phase I-IV studies)
    • Clinical trial requirements
    • Regulatory processes and approval times
    • Understanding of manufacturing processes
    • Ability to assess impact of new regulatory requirements EU and US
  • Good understanding of the Research and Development process as well as the manufacturing processes within drug development
  • Master’s degree or equivalent
  • Excellent English skills
  • Experience in working in a project setting
  • Knowledge of the pharmaceutical industry and its challenges
  • Business understanding/acumen
  • Ability to create strong working relationships across organisation (local experts, editors, consultants and external partners)

Key Characteristics

  • Proactive, Detail oriented, knowledgeable, consultative, problem solver, customer focused, creative, resourceful, fast & flexible, team player, organized

Job ID: R1040358