About You
Are you someone who likes trying new things and gaining different experiences? Than life as a Brunel consultant might be your thing!As a consultancy company specialized in Life Sciences, Infrastructure and IT we are looking for new consultants to join our team of experts.
Your responsibilities
The project covers Business and Technical Analysis activities to support the implementation of ISO IDMP (Identification of Medicinal Products) in Europe, as part of the Data Harmonization & Interoperability Program (DHI Program).
- Collect information in scope of IDMP Iteration 1 in Europe, which are not available yet within internal systems (e.g. RIM)
- The information needs to be collected from source documents (e.g. Module 3, SmPCs), in close collaboration with Regulatory Affairs, CMC… departments and under the supervision of the Data Governance Committee
- The collected information needs to be aligned and harmonized as per IDMP requirements in the EU, and loaded into the relevant source systems
- Contribute to the definition of to-be IDMP submission requirements and processes, to support the selection of a submission tool in line with the objectives of the DHI Program
- Contribute to the integration of the selected IDMP submission tool in the company landscape
- Contribute to the implementation of the submission tool, including user acceptance testing, training materials, procedures, running-in, support to end users…
Your profile
- Education: Bachelor's degree; Background in Regulatory Affairs Operations and/or Information Technology
- General experience: English is required at a fluent level; Knowledge of other European languages is very desirable;
- Knowledge of the European Regulatory Affairs environment including marketing authorization types (CP, MRP/DCP, NP), and the main application types;
- Knowledge of the Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP, SPOR and/or XEVMPD;
- Knowledge of Regulatory Information Management Systems (RIM);
- Knowledge of the structure of information on medicinal products and substances;
- Knowledge of the structure and contents of the Dossier (e.g. Module 3) is a plus;
- 5 years in business analysis and/or project management within large organizations;
- Experience with Software Development Life Cycle (SDLC) to implement GxP systems is a plus;
- Knowledge of MS Office tools is a must, especially MS Excel;
- Experience with the technical aspects of using databases, logical data models, SQL… is a plus;
- Knowledge of Liquent Insight 6.x for Registrations is a plus
Our offer
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
