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Regulatory Document Management Specialist

Posted on Jan 1, 2020 by ARCQ

Mechelen, Antwerpen, Belgium
IT
Immediate Start
Annual Salary
Full-Time
In this position, you keep our new Document Management System in tiptop shape and take the role of the System's Business administrator dealing with the system's metadata and supporting requests to help our users. You will work with various departments to get our documents and templates organised and formatted according to Regulatory requirements. Your role: This responsibility will include the (technical) formatting of scientific and regulatory templates and documents (MS Word or Adobe Acrobat) for submissions to EMA/FDA and other health organizations around the world. Collaborate with cross-functional business partners providing direction and expertise in formatting and publishing of submission related templates and documents, promptly communicating irregularities in documents and coordinating issue resolution; Independently manage DMS electronic study report binders: collection of Clinical Study Report documents and appendices to include into the binder via upload or cross referen...

Reference: 820620480

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