Business Analysis (Regulatory affairs)
ManpowerGroup Solutions takes charge of the insourcing or outsourcing of specific domains within our client’s company, provide support for the entire recruitment process or offer a central point of contact for the hiring of talent. Whilst our clients are focusing on their core tasks, we work to optimize their human capital and all the processes involved in managing it.
Are you a talented employee interested in finding a challenging and rewarding position via ManpowerGroup Solutions? We have plenty to offer you. Our employees are treated like our ambassadors. And as an ambassador, You go and work for our client while getting all the support you need to build a flourishing career as an ‘ambassador’ for MGS: training, opportunities for personal development, and above all an inspirational working environment with a great team that is growing every day.
For our client, located in Brussels, we are looking for Business Analysis Support (Regulatory Affairs) in Woluwe.
• Participation to the global project within Regulatory Affairs and Operations to expand our internal source systems, to become compliant with Article 57 (IDMP in the EU), as well as PQ/CMC in the US. Another objective is to expand the interoperability across these systems, using IDMP as a common language.
• Participation to the setup of a central group to manage IDMP-related data to support Regulatory Affairs activities in scope of the Application Form, IDMP/SPOR, and other EMA systems.
• Coordination of activities to prepare and collect information included in scope of IDMP Iteration 1 in Europe, in close collaboration with European affiliates and a number of departments (e.g. CMC)
• Activities cover coordination, pilot, documentation, training, support, and follow-up IDMP To-Be Processes
• Participation to the definition of to-be IDMP processes, covering essentially the European regulatory aspects, possibly extended to other countries (e.g. Switzerland)
• Participation to the adaptation of internal processes and systems to the replacement of Electronic Application Forms in the EU (CESSP Project).
• Participation to the enhancements of the XEVMPD solution at MSD based on Liquent Insight (although rather stable since March 2020), and the support to the Falsified Medicines Directive in Europe.
• You have a bachelor’s degree
• You have a Background in Regulatory Affairs Operations and/or Information Technology
• You speak fluently English
• You pay attention to details, deadlines and quality is key
• You have an experience in multicultural organizations
You already had to do ;
• Business analysis and/or project management within large organizations;
Exchange standards in compliance with international regulations (Information Model);
Document and records management, content management;
Online transactional processing systems and tracking systems.
• You have a very good knowledge of MS Office
• A contract of specified duration with ManpowerGroup Solutions
• Next to your salary, you will benefit of extra-legal advantages (meal vouchers, hospitalization insurance and group insurance, transportation fee)
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