Belgium *** Clinical Trials Disclosure ** Have you written PSURs or been a Medical Writer *** 10 month contact *** Will renew

Reference: MG120319

Expiry Date: 20-06-2020

Category Clinical Research

Salary: On Application

Job Type: Contractor

Location:
Belgium

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Job Description

Clinical Trials Disclosure Consultant ** Brussels South ** Some Home Working

Location: Brussels, Belgium

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.

Qualifications required:

  • 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.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Matt on +44 7918 679 40 in full confidence to receive more details on this role or to hear about the role and other possibilities.

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