You will be responsible for all activities required to submit and obtain Independent Ethical Committee (IEC) and Regulatory Authority approvals. Activities within this role include liaison with the RA , understanding and knowledge of the RA policies ( administrative orders), preparation and submission of Clinical Trial Applications, Import Licences and safety reporting.
You will be responsible for all activities required to submit and obtain Independent Ethical Committee (IEC) and Regulatory Authority approvals. Activities within this role include liaison with the RA , understanding and knowledge of the RA policies ( administrative orders), preparation and submission of Clinical Trial Applications, Import Licences and safety reporting.
As a Clinical Submission Specialist you will obtain documents and information from site(s) and authorities required for applications as well as liaise with investigators, where applicable, to ensure EC applications are made within the timelines agreed with project management and submission team.
Qualifications
You will need a bachelor's or higher degree in a science related field, licensed or certified health training, or equivalent by experience. As a minimum you will have an awareness of legal and ethical framework, ICH-GCP, country regulations and requirements. You will have strong attention to detail, an ability to work across projects and have an understanding of medical / therapeutic terminology together with good English language and grammar skills
Primary Location
Asia Pacific-India-Maharashtra-Mumbai
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