Clinical Trials Disclosure Consultant ** Brussels South ** Some Home W
Posted on Mar 15, 2019 by Advanced Regulatory (UK & Europe)
I am seeking a self-motivated, bi or tri lingual, consultant who has worked in the past in either trial data disclosure or as a medical or drug safety writer, who now wants to work in more of a holistic position. You will be working with Therapeutic leaders, to set up for each major study, disclosure strategies, and the executing these within matrix teams, after key milestones.
If this was a permanent role, you would be at Associate Director level or near.
As it is a contract role, the initial period is til end of 2019. After that you will be renewed or they will hire you permanently.
Minimum Master's Degree in Biology, Pharmacology or Life Sciences; PhD preferred.
At least 4 years of proven experience in research reporting functions e.g., in the field of Clinical Trial (Public) Disclosure &/or Scientific/Regulatory Writing.
In-depth knowledge & experience of regulations/guidelines/policies governing Clinical Trial Disclosure notably FDAAA & Final Rule and EU Clinical Trial Directive & Regulation; Advanced knowledge of ICH & GCP regulations.
Understanding of statistical concepts in clinical research, methodology in the design, conduct & description of clinical studies, the structure & content of clinical documents (e.g., study protocols & reports), and how to analyze & describe clinical research results.
Proven experience in Project Management - strong project planning skills, proactivity, drive & follow-through; Ability to independently manage multiple responsibilities.
If you wish to apply for this role , please call Matt on or send your CV with a covering note to
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