Senior Clinical RA officer

In the context of a brand new project, we are looking for a consultant to join us asap on the following missions :

• Assistant to draft and update key documents
• Detect opportunities for improvement
• Answers to Competente Authorities administrative questions, in order they can be finalized within expected timelines.
• In charge of following the update of the whole Product Information for the Reference Summary of Product Characteristics for
• Investigational Medicial Products/ Auxilliary Medicinal Product(s)initially identified, by preparing summary comparative tables for Product
• Informations and submitting an impact assessment for validation.
• Notification to the ANSM of New Event/Urgent Safety Measure
• Regulatory surveillance for CTs on World Health Organization database
• Participates in the preparation of any inspection relating to a CT in which you are involved
• In charge of training the employees to European CT Regulation
• To ensure execution and delivery of the study as defined by the protocol and according to agreed timelines, quality standards and CT budget
• To oversee and steer the conduct of the CT from the early preparation until the final CT closure (i.e. from CTsynopsis to CTarchiving)
• To identify and anticipate any deviations on CT deliverables and put in place action plans to minimize impacts
• To provide adequate reporting to the Core Team
• To define the optimal operational strategy
• To provide technical and practical regulatory input/expertise regarding protocol and amendments writing
• To coordinate IMPD volumes and other regulatory documents availability (Cover letter, EudraCT…)To coordinate answers to CAs’ questions by expert of each topic, and to make them available to the Study Team
• To oversee the submissions to regulatory authorities