Ref #: 32612

Employment type: Permanent - Full-Time

Location: Poland

Posted: 28-Sep-2021

Description

Currently for our Client Top Pharmaceutical Company, we look for experienced candidates from start- up department. We has been asked to build a Senior Start- up Specialist embedded solution for our Client Top Pharmaceutical company. Suitable candidates need to have an experience in managing applications for study approvals to the country Health Authority and also central ethics committee. This is due to the changing process in the way European Union trials will be conducted in future. Currently in some European countries, study start up teams submit central and local ethics committee applications within each country while a regulatory team submits to the country health authority. Our Client is looking for people who can do both. This office or home-based role (any location in Poland).



Requirements:
-At least 5 years of experience in both regulatory approval submissions and central Ethics Committee submissions and an understanding of the requirements of the new process.
-Ability to complete regulatory submissions for regulatory approval through the new EU CTR implementation readiness process.
-Strong candidates at managing escalations, responding to governmental agencies and driving the submissions process.
-European understanding and ability to liaise with internal DOCS/ICON local teams to understand local requirements across all European countries.
-Strong leadership and program management skill set as well as ability to meet tight timelines for submissions.
-Ability to communicate clearly and drive requirements to achieve approvals.
-Strong leadership and program management skill set as well as ability to meet tight timelines for submissions.
-Ability to communicate clearly and drive requirements to achieve approvals.
-Fluent English

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