Nourhéne Khalfallah

• Intégration de l'intelligence artificielle dans l'industrie pharmaceutique :Planifier, organiser et coordonner les activités liées aux différents projets. • Evaluer les risques et déterminer le cadre technique des projets en cours. • Recherche et développement d’un outil et d’une plateforme permettant de réduire les risques. •Formation de l'équipe ( gestion de projet, utilisation des différents outils IA) • Participation à la rédaction du Business Case du Projet et des présentations.

Plan, organize and coordinate activities related to securing mRNA materials and processes and their involvement in the corresponding industrial roadmap. Drafting Project Execution Plan. Give the support to Global CMM Risk Prevention Leader to work on materials and Industrial Business Development Director on processes. Establishment of steering and decision-making bodies, streams and core team. Participation in the writing and review of the Project Business Case. Structuring of activity schedules within the Project. Risk assessment. Communication / reporting: Preparing presentations, meetings organization, consolidation of minutes and deliverables.

• Kick-off of the project. • Composition of the team with the competent hierarchy • Manage ongoing projects (documentation, meetings ...). • Management and coordination of New vaccines (NV) projects. • Planning (OPX2: Planisware RDPM), coordination & monitoring of activities with the project team. • Establishment of Project Gantt Charts. • Participation in CMC Meetings • Forecasting clinical needs. • Regular reporting of the project situation (Meetings Minutes, Monthly reports.). • Action tracking. • Project budgeting • Risk definition and management

• Set up,follow-up and reconciliation of clinical projects. • Management and coordination of supply chain projects • Ensure the shipment of pharmaceutical kits to investigation sites and ensure the smooth running of projects. • Interface with hospital, industrial and academic partners. • Participation in the drafting and review of the Extended synopsis, Protocol. • Forecasting clinical needs. • Drafting and validation of the specifications and the distribution strategy in depending on the participating countries. • Request for the addition of additional labels if necessary and review of the associated documentation. • Generation and distribution of randomization list and referral numbers treatments. • Calculation of IMP/NIMP needs and establishment of production plan and distribution of treatment. • Creation and update of IP stock management. • Supervision of destruction and reconciliations. • Participation in project progress meetings with the clinic (Study team meeting ) and meetings with other project actors (PMM..) • Organization and animation of study meetings (OSM). • Preparation of meeting materials and drafting of minutes. • Determination of the charge related to the management of studies and shipments products for clinical trials in agreement with the sponsor. • Participate in the training of other employees of the skills center on the critical activities already mastered. • Participation in the treatment of malfunctions of non-conformities and complaints. • Management of temperature excursions. • Participation in the search for solutions or means of risk control considered. • Contribution to internal improvement for information feedback and experience sharing.

Coordinate and control the establishment and monitoring of the clinical trial. • Ensure the monitoring and scientific, technical and regulatory quality of the project clinical research • Training of the healthcare team • Manage clinical research attaché teams • Control compliance with the scientific and technical-regulatory quality of the study. • Set up the clinical study development plan.

Scientific rare diseases field studies. Project writing, writing and communication in English, Critical analysis of articles. Contribution to data collection and data management on several projects. In the form of an article, writing of a systematic review, respecting the recommendations of scientific publications.

Set up clinical trials. Ensure the monitoring and scientific, technical and regulatory quality of clinical research projects for the institution promoting the drug. Coordinate and control the implementation and monitoring of clinical trials. Interpret and homogenize the information collected by clinical research associates.

Manage ongoing projects (documentation, meetings ...). Implementation of studies: Produce the documents necessary for investigators: the brochure of the study, inclusion and exclusion criteria, patient records, consents. Monitoring of studies: coordination, investigation, monitoring. Exploitation of results: Check the data collected against the source data and supervise the corrections (Queries).

Synthesis of "coilants" chemicals and carry out the various analyzes. Analyze and control the physical and chemical characteristics of a material or a product. Understand the anomalies and implement solutions to deal with them. Ensure the traceability of the tests carried out and the results obtained.

Analyze samples (pharmaceutical and chemical): Perform chemical, physical or microbiological measurements. Interpret the analysis results and Evaluate the conformity of the results. Participate in investigations related to non-conformities. Carry out documentary and bibliographical research and manage current projects (documentation, meeting). Galenic development: Formulation of pharmaceutical forms. Production, monitoring and control of pharmaceutical products.