Stellenbeschreibung

Dr. Notghi CRO is a contract research organization (CRO) providing statistical, data management, monitoring and medical writing as well as e-learning, workshops and training services to pharmaceutical, biotechnology, and medical devices companies. We are currently seeking a highly qualified and motivated person for this position. Responsibilities: •You are responsible for the processing of national and international registration processes •Support in the preparation of registration dossiers and renewal applications and notifications of changes •Maintenance of registration documents in electronic databases •Communication with authorities and ethics committees •Literature review •Work closely with other departments Qualifications and Experience: •Degree in of statistics, mathematics or comparable study or education in a relevant field •Independent and structured work and analytical thinking •Very good English knowledge and good knowledge of German is desirable •Willingness to work in a team •Several years of professional experience in Regulatory Affairs •Very good knowledge of relevant regulations and guidelines •Experience in approval procedures Europe (national, MRP, DCP, CP), national non-European authorization procedure, Regulatory Strategies Please send your application to: jobs@notghi.com or use our online application form. Dr. Notghi Contract Research GmbH Ihre CRO in Berlin! www.notghi.com