PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients
Post: Clinical Submission Specialist (India) - 003744
Job Description:
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 ECapplications are made within the timelines agreed with project management and submission team.
Candidate Profile:
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
Additional Information:
Exp: 2-3 yrs
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
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