Asset Management Compliance Specialist
hace 1 día
Overview Due to our ongoing global expansion, we have a great opportunity for a Regulatory Submissions Specialist to join our growing regulatory team in Taiwan, on a fully remote basis. Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación. The Regulatory Submissions Specialist contributes to the management and development of procedures related to the activities in which he/she is involved in and ensures that the outputs of their activities meet the quality standards required by the company. Develops and maintains knowledge of global and local regulatory requirements and industry practice/guidelines for submission activities. to local requirements. Responsibilities Manages contract and budget negotiation/execution with sites/investigators/other parties involved as applicable. Ensures outputs of regulatory activities meet quality standards required by the company. Maintains knowledge of global and local regulatory requirements and industry practice/guidelines for submission activities. Qualifications and Skills Contracts and budget negotiation Fluent in English Good planning, problem solving and organizational skills Please read the information notice on the processing of personal data in the candidates' information section of our company website. About OPIS OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects. OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training. #J-18808-Ljbffr
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