RIM, Senior Manager
Switzerland or remote UK, Germany, France, NL
Our collaborator is a pharmaceutical company revolutionizing rare disease treatment among others by targeting immune system pathways.
As they successfully reached the clinical stage, they are looking for a RIM (Regulatory Information Management) Senior Manager who would join their international regulatory team to support their further RIM Software development and implementation.
If you are a data-oriented person who enjoys working in a cross-functional environment, this could be the right opportunity for you. Let’s move to the main responsibilities:
_Assist in the implementation and management of a comprehensive data governance model, based on current health authority requirements.
_Support the management of end to end Regulatory data/information
_Participate in the implementation of a RIM system (including requirements definition, getting stakeholder input, process mapping etc)
_Have regulatory intelligence related to RIM and regulatory submission requirements (Europe and International)
_Be in charge of the reports and dashboards used internally and externally
_6 years of experience with RIM (Especially Veeva)
_Experience in submitting on EMA portal
_Knowledge in eCTD/CTD structure and requirements as well as submission requirements
_Confident in cross-functional communication and presentation
_Being willing to work from home if located far away from the German-speaking part of Switzerland
***Please forward your application should you meet the requirements above – applications which do not meet these requirements will not be considered***
headcount AG is a Zurich-based consultancy serving clients in the pharmaceutical, biotechnology, medical technology and chemical market segments.