Our client a Biotech company, based in Maidenhead is looking for a Senior Regulatory Affairs Systems Specialist.
This role requires the candidate to be technically focused with processes and systems as you will be looking after the implementation and upgrade of regulatory systems and partnering with an IT Project Manager.
This is a temporary role to start ASAP for 12 months, possibly longer.
- Provide essential project management support to Global Regulatory Affairs' in-flight electronic document management system upgrade project (known as ESMS).
- Support the system Business Process Owner with business analysis activities, requirements definition, system validation documentation, UAT script creation / execution and training development and delivery.
- This is a project moving from Documentum to Veeva so will need to maintain the Documentum system.
- Well versed in supporting large scale electronic document management system implementation / upgrade projects in the context of Documentum Life Sciences D2 (essential) and Veeva Submissions Vault (essential) within the pharmaceutical Regulatory business.
- Understand project management approaches
- Keen awareness of computerised system validation techniques and approaches.
- 3 years minimum Regulatory background essential
- Pharmaceutical experience advantageous but not essential.
- Project Management
- Regulatory Affairs
- User Acceptance Testing
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