Start up Specialist Belgium

Resourcing Life Science Ltd.

Belgique

À distance

EUR 40 000 - 60 000

Plein temps

14 jours+

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Résumé du poste

Resourcing Life Science Ltd. in Belgium is seeking a Start up Specialist to support EC/CA submissions within a global CRO environment. This home-based role requires coordination of translations and ensuring study conduct aligns with GCP and ICH guidelines.

You will manage CA & EC submissions, stay current with regulatory requirements, and collaborate with cross-functional teams to deliver submission-ready documents across phase II–III studies. Fluency in English and Dutch or French is required.

Qualifications

Bachelor degree in life-science required.
Minimum 1.5 years in EC & CA submissions within CRO/Pharma/Biotech in Belgium.
Experience in clinical studies phase II-III.

Responsabilités

Responsible for CA & EC submission.
Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
Translation and coordination of translations for documents required for submissions.
Supervising study conduct according to GCP requirements and all applicable laws.

Connaissances

Fluent English

Dutch or French

Formation

Bachelor degree in life-science

Description du poste

Company Description

Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Start up Specialist home based in Belgium.

Job Overview

Responsible for CA & Ethics Committee (EC) submission
Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
Translation and co-ordination of translations for documents required for submissions.
Supervising study conduct according to GCP requirements and all applicable laws.

Key Requirements