Regulatory and Start Up Specialist (FSP) Belgium

IQVIA

Brussels

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. _At least 3 years' experience with submissions. Dutch and English fluent._

Essential Functions

+ Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

+ Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

+ Prepare site regulatory documents, reviewing for... More Detail

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