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Medical Research Advisor

Job Description

  • To be responsible for Development Clinical Trials from the medical/scientific point of view, integrating insights from internal and external stakeholders, in order to perform an adequate country and protocol feasibility;
  • To provide a high level of medical expertise in the area of Clinical Drug Development to ensure the alignment to the Clinical Development Plan and the appropriate feedback to cover the CPO business priorities and early product planning 
  • To provide medical expertise specific to the country for Clinical Drug Development and Clinical Operation activities;
  • To lead and/or perform protocol, country and site feasibility. Provide consolidated feasibility and site selection input to global teams;
  • To provide protocol & disease training as appropriate at Investigator’s Meetings, scientific venues and internal stakeholders;
  • To provide medical expertise to Clinical Operations activities when necessary,
  • To ensure accuracy of translation of medical information related to clinical trials when translated into the local language, including the writing/validation of the country specific Informed Consent Forms (ICF), endpoints, AEs, SAEs and patient narratives;
  • To may be called upon to provide strategic medical input into 2;
  • To support ICRO and Global teams in the interaction with regulatory agencies;
  • To support planning, implementation and follow-up of regulatory agency inspections and internal audits;
  • To support Early Product Planning Team (EPPT), Drug safety and epidemiology (DS&E), Medical Information, Regulatory Affairs and Health Economics with medical input as appropriate as this relates to clinical trials;
  • To participate in activities related to pharmacovigilance system as appropriate
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Eva Pique
52 (55) 55 31 78 87