Principal Regulatory and Start Up Specialist

Job description

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.: As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team. Essential functions of the job include but are not limited to: Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. and local/national applicable regulations. - Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country. - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within requi...