ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Study Authorisation Associate - All Levels
Job Description:
Role Responsibility
Working within a highly qualified team you will prepare submissions packages for 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 legislation.
In addition you will complete all amendments and respond to submission related queries from the Clinical Teams. Maintaining regular contact with the designated personnel from Regulatory Authorities & Ethics Committees, you will 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, as well as training and mentoring new staff.
Candidate Profile:
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.
You must have knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data. You should also demonstrate an understanding of regionally specific legislation surrounding ethics committees and submissions procedures and practices.
Bi-Lingual – you must be fluent English and the local language as all submission documents to sponsors and many authorities must be compiled in English. You will also have excellent interpersonal and presentation skills along with the ability to interact at all levels in this client facing role.
A highly organised team player, you will have the ability to prioritize work demonstrating a pro-active attitude with excellent attention to detail.
Computer literate, you will have a good working knowledge of Microsoft applications, especially PowerPoint.
Additional Information:
Location: Bangalore
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 76
End Date: 3rd Oct., 2011
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