SANOFI

Recherche & Développement

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d’inclusion et créer un environnement de travail où ces différences peuvent s’épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.

Clinical Inspection Readiness Leader The Clinical Inspection Readiness Leader (CIRL) is an “expert” leader responsible to lead Clinical Inspection Readiness (IR) and Pre-Approval Inspection (PAI) activities and to identify strategic solutions for continued improvement across clinical, where needed.  He/She can also be a Clinical Quality Risk/Alert Leader for assigned risks.  Overall, the CIRL leads large transversal projects that support inspection readiness for which significant changes/improvements to business processes are expected across R&D and beyond.  Responsibilities Leads the development of Inspection Readiness and Pre-Approval Inspection Preparation with respective clinical study team leaders and applicable Co-Development Partners and CROs.Provides required leadership and support pre, during and post regulatory agency sponsor-monitor inspection with the goal to ensure clinical teams are able to withstand the scrutiny and questioning of a sponsor monitor pre-approval inspection.Defines and develops strategies to work with cross functional departments to build ‘inspection readiness’ and consistently identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study reporting and transversely across processes.Develop and obtain quality-driven, risk-based metrics; evaluate and report metrics forecasts and trends to ensure internal and external adherence to inspection readiness expectations Leads strategic initiatives, either autonomously or collaboratively, that target continuous improvement and achievement of operational excellence to support inspection readiness.May need to function as Clinical Quality Risk manager (CQRM and be in charge of analyzing the different signals / events related to clinical activities to profile the quality risks, establish their impact and propose and manage their mitigation Requirements & Qualifications Bachelor degree or higher in a relevant scientific/health-related field.Minimum of at least 10 years’ experience in the pharmaceutical industry, with a minimum of  6-8 years’ experience in GCP clinical and/or GCP quality operations-related roles (e.g., GCP auditing, clinical trial monitoring, trial management or Pharmacovigilance)Demonstrated ability to lead complex projects/assignmentsExtensive knowledge of Research & Development with past experience in clinical operations, preferably global clinical trial management and/or GCP Quality and FDA/EMA GCP inspections.  In-depth knowledge of GCPs, ICH and, if applicable, Sanofi SOPs.Quality focused with a high degree of personal accountability and commitmentDemonstrated skills in self-motivation, taking initiative and working independentlyStrong knowledge on project management (global clinical projects; clinical process improvement projects)Strong knowledge of international good clinical practices (ICH) and understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance ManualKnowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissionsStrategy focused with ability to extrapolate detail without losing sight of big pictureResults driven with attention to detail and quality while overseeing and connecting with contributing stakeholdersExcellent team leadership, presentation, interpersonal and communication skills (written and verbal)Rigor, diplomacy and good analytical abilitiesStrong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics.Demonstrated ability to bring consensus among diverse cross functional teams and to drive results within established timelinesAble to manage and negotiate complex and/or sensitiveDemonstrated ability to anticipate problems/ changes impacts, consequences, and delays; work proactively and take the initiative for corrective measures.Ability to analyze trends and determine strategic improvement needs; ability to execute and monitor the implementation and progress of such improvement processesAbility to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines. Preferred Experience SharePoint knowledge & experienceInnovation and analytics for data management and metric developmentExperience with FDA, EMA or other regulatory inspections of sponsor, investigator sites, or CROs Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.  All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA#LI-SA