Clinical research physician, global rare diseases

30 ago - Italia
Chiesi Farmaceutici

Clinical Research Physician, Global Rare Diseases Department: GRD Clinical Development Business Area: R&D;, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Europe (flexible) – remote or hybrid What you will do Support the clinical team in relevant medical and scientific aspects of the assigned global clinical studies within the global clinical development program Contribute to the risk/agevolazioni assessment of the ongoing clinical trials assigned May act as the primary medical monitor for an assigned clinical study Contribute to the production of the Common Technical Document, in terms of validation of scientific documents relevant to the assigned clinical study (e.g., study protocol, investigator's brochure, clinical study reports) and represent the company in front of health authorities, partners and institutions Develop and enhance the management of the clinical trials,



working in collaboration with the Clinical Program Leader and other relevant roles and ensure medical and scientific validity of the assigned clinical studies in terms of design, conduct and interpretation You will be responsible for Acting as a member of the program meetings and/or Clinical Study Team, to support the design, conduct, analysis and data interpretation of assigned clinical studies, including the preparation of key relevant clinical documentation in accordance with the Clinical Development Plan and agreed timelines Conducting medical and scientific review on the data of the ongoing and completed clinical trial data with appropriate oversight Supporting the Clinical Program Leader in interactions with internal and external stakeholders, acting as the subject matter expert in the assigned product(s) and relevant disease(s) area, and maintaining and enhancing knowledge in relevant technical or therapeutic areas and in global regulations/guidelines Interfacing a diverse range of scientific external experts (e.g., regulatory, payors, CROs, c

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