GRA Regulatory Knowledge Specialist
Hendre Moolman is recruiting for a contract Regulatory Knowledge Manager to join a pharmaceutical company at their site based in Slough on a contract basis for a 12-month contract.
Our client is a multinational patient-focus biopharmaceutical company that focus on severe diseases.
The role is based at our client's site in Slough which is easily commutable from London and the surrounding areas.
The main purpose of the role will be to:
- Provide support, training and assistance to colleagues in manage its regulated content and regulatory information.
- Analyse, remediate and disseminate information held in regulatory databases to maintain and manage the diverse product portfolio
- Suggest modifications to known procedures and processes to overcome issues in an effective and time-efficient manner; use initiative in improvising and identifying new approaches to work practices; maintain current awareness of new technology and incorporate the department's goals into the proposed solution.
Further responsibilities will include:
- Providing first-line business support and end-user training for use of global license tracking database and document management system.
- Follow up with the end users regarding data or content quality issues; identify areas for improvement in process documentation / training
- Authoring, Reviewing and Approving documents including Validation Deliverables, SOPs, Release Notes, User Guides, Protocols, Reports and FAQs
To succeed in this role, you will come from a Regulatory Affairs background in processing of regulatory information management (RIM)
- Experience is required in supporting end users to enter and maintain product information in a registration tracking database
For more information or to apply for this position, please contact Hendre Moolman on 01438 842970 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47045 in all correspondence.