PPD is a leading global contract research organization, celebrating 25 years of providing discovery and development services and drug lifecycle management. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe, effective therapeutics to patients and maximize returns on their R&D investments.We seek to attract the best and the brightest talent by providing a stimulating and challenging environment. Our employees take pride in delivering innovative ideas, exceptional service and consistent quality to our clients. We understand our employees are the key to our success, and we acknowledge and reward their excellence.
Duties:
Performs and coordinates all activities required to submit and obtain Ethics Committee (EC) Opinion.
Performs submission admendments and all activities to obtain ongoing EC opinion throughout the life of the study.
In those countries where there are no local regulatory presence, performs and coordinates all activities required to submit andobtain competent Authority (CA) approval.
Requirements:-
Degree inScience or related
At least 2 years of experience workingin a regulatory affairscapacity
Experience with handling of EC/CA applications is desired and as well as good working knowledge ofICH/GCP, SOPs, WDPs and applicable clients SOPs.
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