Master Data Manager

EMA is currently moving through a period of significant digital transformation (technology, data) and it is critical to ensure successful and effective delivery and management of the new Master Data Management services on Substances, Products, Organisations and Referential data (also known as SPOR) and support of the implementation of ISO IDMP at the EU. This is a great opportunity for someone looking to move out of a traditional working environment and move into the exciting new world of data within the EU Medicines Regulatory Network, and who wishes at the same time to apply the skills and experiences developed to date. Through your engagement in projects you will be defining the required IT solutions and driving the relevant changes in data and processes. You will also be engaged in outsourcing some of the data registration services and setting up a Data Quality assurance framework. As SPOR is used across all regulatory processes you will be working in a multi-stakeholder, dynamic environment and be able to expand your knowledge of the Products Information Lifecycle and see first-hand how that evolves into a digital transformation.

Experience in Data management, including:

• Data curation, compliance to standards and publication: including data creation/update; map, match and consolidate data sources; merge data and perform duplicate management; unmerge data ensuring data lineage.
• Safeguarding data quality, accessibility, interoperability: including Simple/complex reporting; Data profiling, building/maintaining Data Quality Dashboards, Data Quality controls and auditing.
• Maintaining historical information and corresponding data sources (data provenance): includes unmerging data ensuring data lineage.

Basic knowledge of:

• Pharmaceutical Regulatory aspects covering the Medicinal Product lifecycle from product research, development, evaluation, authorisation and post-authorisation management.
• Project and Portfolio Management, covering the project lifecycle from initiation, planning, execution and closure.
• Relationship management including establishment and maintenance of business relationships with customers, suppliers and other stakeholders
• Business Change Management through delivering of impact and benefits assessments, communication and training.

Sound knowledge and/or professional experience in:

• Pharmaceutical Regulatory aspects;
• Project and Portfolio Management;
• Relationship Management;
• Business Change Management;