Submissions Specialist

Submission Specialist – Remote working, based in Italy

I am currently recruiting for a Submission Specialist to join our client, an established European CRO to work remotely, based in Italy. .Really exciting time to join our client during its company expansion.

Typical responsibilities will include

·Developing and maintaining knowledge of global and local regulatory requirements and industry practice/guidelines for submissions activities

·Managing the preparation of local documentation for submission

·Managing activities associated with obtaining initial and amended central authority approvals

·Managing activities associated with obtaining initial and amended site Independent Ethics Committee (IEC) / IRB / other competent body as applicable approvals

·Managing contract negotiation/execution/payments with sites/investigators/other parties

·Maintaining tracking of regulatory, ethical, and administrative authorisations

·Staying in touch keeping project team members up to date

·Updating any regulatory information on company system

Who are we looking for?

You will have graduated with a bachelor’s degree within the life sciences with previous experience gained within a CRO.Basic knowledge of applicable regional/national regulatory guidelines and EC regulations required.

For further information please contact Louise on +44 (0)1293 364114