- Sanofi Group (Framingham, MA)
- …plan + Reviewing the internal audit reports before submission to senior management to ensure accuracy and consistency + Ensuring an inspection readiness process ... skills to effectively liaise with regulatory bodies, present findings to senior management , and train staff + Proficiency in managing multiple audits and inspections… more
- Sanofi Group (Cambridge, MA)
- …the core product labeling for products in development as well as for lifecycle management of products. + May serve as a regional/local regulatory lead and point of ... including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or… more
- Sanofi Group (Cambridge, MA)
- …deliverables. + Communicate the details and progress of the Medical Plan to Management , the Core Team and all parties responsible for execution. + Ensure strategic ... according to applicable SOP(s). + Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the… more
- Sanofi Group (Cambridge, MA)
- …play a crucial role in shaping the user experience of our health management platform. You will be responsible for translating user needs, business requirements, and ... (eg, HIPAA), accessibility standards (eg,WCAG), and user behavior in health management . + A strong portfolio showcasing user-centered design solutions and… more
- Sanofi Group (Framingham, MA)
- …+ Presence on the shopfloor with formal traceability of the observations. Inform management and feedback operators (A) + Contribute to quality documentation SOP and ... skills to communicate with a large number of functions (from shopfloor to management ) and to present complex subjects + Ability to organize and lead routine… more
- Sanofi Group (Waltham, MA)
- …fit-for-purpose of Lab Digital Products for Vaccine R&D across functions + **Change Management ** : Drive adoption of new digital ways of working through influence ... authority, with demonstrated success in cross-functional collaboration + **Change Management ** : Experience guiding organizations through digital transformation while… more
- Sanofi Group (Cambridge, MA)
- …Knowledge of Veeva Vault RIM platform for regulatory information management : submission documents, registration tracking, agency interactions, and dossier archiving ... processes and DevOps methodology / principals + GIT-based source code management (GitHub) and Continuous Integration and Continuous Delivery (CI/CD) practices… more
- Sanofi Group (Cambridge, MA)
- …into cross-functional programs including IEGP development, launch readiness, lifecycle management , customer experience, and therapy area planning + Establish ... digital fluency across Field Medical organization to ensure future readiness **Performance Management & Governance** + Develop and oversee global KPIs that measure… more
- Sanofi Group (Cambridge, MA)
- …and regulatory requirements on analytical methods + Prior CMC project management experience + Excellent communications skills **Preferred Qualifications** + Ability ... CMC team meetings + Having a record of success in CMC project management + Having working knowledge of synthetic chemistry and pharmaceutical development +… more
- Sanofi Group (Waltham, MA)
- …of AI/ML applications in pharmaceutical development + Knowledge of digital quality management systems and electronic batch records **Skills you will advance and ... applications and prompt engineering + Organization skill for planning, time management , and communication + Constantly question and challenge status-quo and propose… more