Business Analyst IDMP
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Waals-Brabant Belgium.
They are a pharmaceutical company with an entrepreneurial spirit focusing on delivering innovative medicines for patients.
ROLE DESCRIPTION
The Business Analyst IDMP will work within the RA/IT department. He/she will be responsible for leading the IDMP project from business perspective and for fulfilling business analysis activities.
RESPONSIBILITIES
- Support the IDMP implementation within the organisation, ensure compliance to the EU requirements with regards to quality and timelines
This includes efforts such as data pilots, mapping of internal data/systems with IDMP, support migration off IDMP
- Monitor requirements change for IDMP, contribute and influence where possible to facilitate rapid implementation
- Participate to external working parties (with HA's, Industry, Vendors) to maintain compliance and ensure implemented systems and processes are evolving with regulatory requirements
REQUIREMENTS
- Medicinal product information (structure of information on medicinal products and substances)
- Information standards to represent medicinal products and substances (Information Model)
- Knowledge of EU/EEA regulatory environment and related information systems (RIM)
- Experience in multicultural organisation is desirable
- Knowledge of additional functional areas (e.g. CMC, supply chain, clinical trials…) is a plus
- IT background with experience in Regulatory Affairs
- Available for at least a year
- Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Niek Schreurs.
