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Clinical Trial Application Specialist - VIE Contract W/M

date posted 04/28/2024
contract type Full time
job id R2738959
location Budapest, Hungary

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission:

Clinical Trial Application Specialist - VIE Contract (W/M)

Target start date: 01/07/2024

As a Clinical Trial Application Specialist VIE you will:

  • Follow up/monitoring of CTA operational planning activities.
  • Manage activities related to CTA documentation in close collaboration with the Clinical trial team, and the Regulatory team (coordinate, follow, check availability of component and completeness of CTA dossier and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments, etc.).
  • Manage activities specifically related to the Clinical trials under the European Regulation and its operational processes in the Clinical Trial Information System (CTIS).
  • Prepare appropriate CTA documents in the Sanofi repository systems.
  • Activities related to Development Safety Update Report (DSUR) delivery.
  • Manage activities related to tools /Sanofi Regulatory document and registration tracking tools (Vault RIM).
  • Contribute to data quality control (QC), and appropriate data remediation in Vault RIM.
  • Monitor Key Performance Indicators by running reports, collating data and report as per oversight and governance process.
  • Contribute to the Regulatory Intelligence process.

Key “MUST HAVE” competencies, skills & experiences:

  • Pharmacist / Scientist or other related degree.
  • First experience in Regulatory Affairs or other relevant experience.
  • Good communication skills & negotiation skills.
  • Ability to solve issue & pro-active behavior.
  • Ability to work with multi-function teams.
  • Ability to manage multi projects.
  • Fluent English is a must.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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