Business (General) (Other) in Belgium Business (General): Other in Belgium

Study Authorisation Associate - Submissions

Posted in: Jobs: Other in Belgium
Last updated: 10/06/10

Role Responsibility

Working within a highly qualified team you will prepare submissions packages for the country specific Regulatory Authorities and Ethics Committees for the region within which you work. You will liaise with the authorities as appropriate regarding amendments and questions relating to start up activities.

Additional Responsibilities:

Working proactively as part of a project team you will coordinate all necessary activities required to gain Regulatory & Ethics Committee approval for clinical studies.
You will be required to collate and prepare all documentation and dossiers for regional study approval in accordance with the relevant local legislations. In addition you will complete all amendments and respond to submission related queries from the Clinical Teams.
Regular contact with the designated personnel from Regulatory Authorities & Ethics Committees must be maintained in order to monitor the submission progress in accordance with study start up deadlines.
As your experience develops, you may be expected to take the lead on regional projects, reporting directly to the Regional ISIS Manager.

Experience and Qualification With a University degree in medicine, science, or equivalent, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharma company. In addition you will also require:

Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data
Demonstrate an understanding of regionally specific legislation surrounding ethics committees and submissions procedures and practices
Have excellent interpersonal and presentation skills and the ability to interact at all levels in this client facing role
Bi-Lingual – you must be fluent native speaker with fluent English since all submission documents to sponsors and many authorities must be compiled in English
Ability to prioritize work, have excellent attention to detail, demonstrate a pro-active attitude and have previously worked within a team.
Good working knowledge of Microsoft applications especially PowerPoint.

You will have the opportunity to progress your career and may wish to move into Management or into other related areas where you can further develop your skill set.