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Opis stanowiska Regulatory Submissions Manager


My client is an international CRO with an office in Warsaw.
                  
Main responsibilities;


Efficient and accurate managing all aspects of one or more projects on a global level according to Sponsor specifications; oversee regulatory activities at project start-up and throughout the study. This includes maintaining start-up timelines; maintaining ongoing Sponsor contact for regulatory issues by serving as the primary contact for the Sponsor and project team members; independently interact with Sponsor, sites, IRB/ECs, regulatory agencies and the study team; provide regulatory advice and guidance to the client’s team to ensure compliance with appropriate regulations and requirements; contribute to core and country specific Informed Consent templates and negotiate/review content changes; line management of Study Start-up Coordinators and Study Documents Specialists; review pertinent regulations and guidance’s to develop proactive solutions to regulatory issues and challenges.


Job Requirements 

A Bachelor's degree in a relevant field
4+ years of job experience in a clinical trial environment;
Knowledge of local regulations regarding clinical studies and the conduct of such studies;
Strong oral and written communication skills; and
Excellent computer skills, including a working knowledge of Microsoft Office applications.




Oferujemy

http://www.hays.pl/szukam-pracy/JOB_901534?jobSource=XMLFeed
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