Location: Europe, Middle East & Africa-Bulgaria-Sofia-Sofia
Closing Date: 11 Dec 16
Type: Full Time
Salary (£): On Application
PPD is a leading global Contract Research Organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...
PPD is a leading global Contract Research Organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 16 000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit http://www.ppdi.com/. As a result of the newly formed Site Intelligence and Activation (SIA) group in PPD, there is currently a vacancy for a Country Approval Specialist to join our team of global professionals. The Country Approval Specialist will manage the preparation, review and coordination of EC and Regulatory submission in Bulgaria. There will be extensive contact with people in the local team, throughout the company, with other regulatory consultants, with clients, study sites and with the regulatory agencies as applicable. Duties and Responsibilities include but are not restricted to: • Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy • Provide, under guidance, local regulatory strategy advice to internal clients • Provide project specific local submission service and coordination oversight for projects in collaboration with relevant internal departments • Act as a key-contact at country level for all submission-related activities • Coordinates, under guidance, with internal functional departments to ensure various study site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for study sites and study are aligned to the critical path for study site activation • Prepare the regulatory compliance review packages with CRA, as applicable • May develop country specific Patient Information Sheet/Informed Consent form documents • May Support the coordination of feasibility activities, as required, in accordance with agreed timelines • Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. • Oversees country study files and ensures that they meet PPD WPD's or client SOP's• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
QualificationsRequired are: • Scientific degree, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage • 2 years related regulatory/ submission experience or equivalent combination of education, training & experience would be an advantage • Effective oral and written communication skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the ability to learn appropriate software • Good English language and grammar skills • Ability to work in a team environment or independently, with minimal supervision • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations HOW TO APPLY: Please visit our internal corporate website go to Careers / Career Opportunities and select the appropriate location - EMEA, Bulgaria and find the job. Please submit your CV in English. Registration on our website will also give you the opportunity to be considered for other positions if this one is not the most appropriate for your qualifications and experience. This is an ongoing search. Suitable candidates will be contacted accordingly.
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