Regulatory Submissions Manager
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Regulatory Submissions Manager - Ogłoszenie archiwalne
Praca Hays Poland / Farmaceutyka / Biotechnologia / Warszawa
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Regulatory Submissions Manager
Warszawa
Regulatory Submissions Manager
Warszawa
Nr Ref.: 1018998
Warszawa
Nr Ref.: 1018998
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.
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.
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