Description
One of our World leading Clients in Medical Devices are looking to recruit a Submission Specialist on a 6 month contract ASAP. In your role as a Submission specialist you will be responsible for the followsing dutiesL- Manage E2B submissions per standardised operating procedural documents. Review ICSRs for local reportability, make submit/no submit determination, monitor successful transmission.
- Perform dsExchange activities as neede
- Perform administrative duties associated with LCR/E2B; produce CIOMS/MedWatch and fax/email, distribute, and upload to document storage
- Perform dsExchange activities as needed
- Monitor transmissions/E2B case failure monitoring and (if appropriate) handling
- Liaise with support desk and/or case processing personel
- Prepare issues for escalation up to manager which may be escalated to QPPV
- Document and track compliance related data
- Perform reconciliation
- Participate in user acceptance testing for upgrade/enhancements to LCR including support of script writing.
- Perform documentation storage (archiving)
- Participate in process improvement Training and Development.
So if you feel like this fits your skills please get in touch with Jamie McLaren on today.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales