Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.
We are currently 1200+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and the North East and global offices in the US, Asia Pacific, South Africa, and across Europe. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.
Reporting to the Quality Compliance Manager, the Quality Officer will ensure compliance functions are carried out in line with domestic licence obligations. Provide comprehensive support to internal customers who require compliance-based advice.
This is a 12 month fixed term contract and will be based at our Weybridge site.
Responsibilities (Not exhaustive)
- Processing of daily import notifications and subsequent acknowledgements
- Contribute to the management and review of NOI inventory planning levels in line with business and patient demand.
- Ensure cover for all operational daily compliance duties in co-operation with colleagues.
- Generation of country specific notifications.
- Creation/Maintenance of Quality Compliance ERP Components.
- Internal and External processing of Special Clinical Needs letters, including processing of urgent requests.
- Participate in projects to implement new, or improve existing Quality Compliance processes.
- Preliminary horizon scanning of Quality/Regulatory websites and resources.
- Support business in resolution of item queries due to discrepancies.
- GCSE Grade C or above in English and Math (or equivalent)
- A strong working knowledge of GMP and GDP
- Excellent written and verbal communication
- Knowledge of Unlicensed Medicines (Specials)
If this role is of interest to you, please email a recent copy of your CV and a covering letter to email@example.com and a member of the Talent Acquisition team will be in touch.