PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory 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 15,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit .
We have an exciting internal opportunity for you to join the Site, Intelligence & Activation (SIA) on a permanent basis.
As a Country Approval Specialist, you will manage the preparation, review and coordination of country submissions in Madrid.
Main duties and Responsibilities include:
Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy Provide local regulatory strategy and advice Act as a key contact on a country level for all submission related activities and provide oversight for projects Coordinate, under guidance, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelinesQualificationsQualifications
· Demonstrated experience in start-up activities (EC and CA submission management; ICF customization; Annex management) · Deep knowledge in EU and Spanish Clinical Research Legislation · Understanding of ICH-GCP · Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures · Strong attention to detail · Customer focus · Effective communication and interpersonal skills · Good organizational and time management skills · Ability to work in a team or independently as required · Fluency in English and Spanish, both written and spoken · University degree in a health/science-related will be an advantage
Closing date for applications is Friday 24th June 2016