Als Project Manager Dossier Harmonisation, you will provide project management support for 2 projects.
Your main responsibilities will be:
• Participation in Dossier Harmonisation Steering Committee and product-specific project team meetings (agenda preparation, writing of minutes, follow up of actions)
• Planning, preparation, circulation, and revision of the Dossier Harmonisation Project Plan for designated projects/products (assembly of implementation plans, coordination of preparation and submission of dossier applications and responses to questions raised by Regulatory Authorities.)
• Use of ETS-RT registration database to respond to queries and update records. Actively work with the ETS-RT Administrators to correct identified issues.
• Use of Global Document Management System (Veeva Vault) and ETS to store and retrieve marketing authorisation documentation and registration dossiers.
• Use of the department communications systems to ensure visibility of current and planned submissions.
• Participate in departmental activities as appropriate to meet project objectives.
• Other specific duties and responsibilities as detailed by supervisor.
For more information: contact Aline Vandermeeren +32 16 30 95 09