- Sanofi Group (Cambridge, MA)
- …of cases. + Collaborate with cross-functional teams (Medical, Regulatory, Pharmacovigilance ) to implement planned deviation processes for product launches. ... **Operational Excellence & Project Management** + Establish project timelines and governance for new product launches to ensure readiness and compliance. + Drive continuous improvement initiatives to enhance audit preparedness and operational efficiency. +… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …**Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance , and other functions to ensure alignment on quality ... expectations and audit outcomes. + **Continuous Improvement** : Identify trends and systemic issues from audit findings and contribute to the development of global quality improvement initiatives. + **Training & Guidance** : Provide GCP compliance training and… more
- Sanofi Group (Waltham, MA)
- …of technical success. + Contribute with project team members (ie: clinical, pharmacovigilance , regulatory, ) to gain Health Authorities acceptance of the plans, ... accountable from a statistical standpoint. Seek support from the Biostat Franchise Lead as needed. + Oversee for his/her project the execution of the respective clinical trials: Data capture, Randomization, Statistical Analysis Plan, Analyses deliveries for… more
- AbbVie (North Chicago, IL)
- …Management (QRM), covering multiple domains such as Clinical Operations, Pharmacovigilance , pre-Clinical, or Manufacturing. + Deep knowledge of global regulatory ... frameworks, inspection readiness, compliance standards, and QRM methodologies, including maintenance of risk logs/registers. + Demonstrated capability to standardize and scale quality and risk management processes globally to enhance operational efficiency and… more
- BeOne Medicines (San Mateo, CA)
- …development intelligence, US Marketing, Global Marketing, US Sales, safety/ pharmacovigilance , molecular diagnostics, new markets, and translational research. The ... incumbent will play a key role in the establishment of BeOne as a valued collaborator and best-in-class biopharmaceutical company while exemplifying BeOne Core Values Essential Functions: + Oversee the daily 1st line manager activities of the Field Medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …Quantitative Sciences, Programming, Global Evidence Outcomes, Patient Safety & Pharmacovigilance , and Strategic Operations The department integrates data science, ... analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate… more
- AbbVie (Florham Park, NJ)
- …responses and discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly… more
- Teva Pharmaceuticals (West Chester, PA)
- …relating to clinical trials, research and development, data privacy, pharmacovigilance , and other R&D-related matters, worldwide. This role counsels clients ... on a wide range of regulatory compliance issues with a focus on current GCPs and GLPs, including quality and contracting processes related to the research and development of innovative, biosimilar, and generic pharmaceuticals around the world. The attorney… more
- Lundbeck (Deerfield, IL)
- …internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with ... integrated evidence generation plans. + Identify, develop, and maintain strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners by fostering productive partnerships. + Remain intimately aware and… more
- Lundbeck (Deerfield, IL)
- …internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with ... integrated plans + Drive an ambitious external engagement agenda by identifying, developing and maintaining strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners; foster productive partnerships,… more