Hobson Prior currently have an opportunity for an RA Consultant - IDMP support to join a leading pharmaceutical organisation focused on saving lives all over the world by discovering, developing and offering pioneering products and services.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• 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.
• The mission will be conducted in close relationship with the IDMP Global Business Leads (US- and EU-based), the European IDMP Team, Regulatory Affairs Operations, Regulatory Affairs and the European Authorities.
• 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, 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.

Requirements:

• Bachelor's degree.
• Background in Regulatory Affairs Operations and/or Information Technology.
• 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.
• Document and records management, content management.
• Knowledge of the European Regulatory Affairs environment including marketing authorization types, and the main application types.
• Knowledge of the Pharmacovigilance regulation 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 is a plus.
• Experience in multicultural organizations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.