- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …external pressures (eg, 340B, patient leakage) and internal shifts (eg, LOE management , innovative distribution models), this role will be critical in anticipating ... Responsibilities:** + **Proactive Program Optimization:** Own the end-to-end performance management process for affordability and channel programs across in-line… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oncology organization needs by ensuring ethical behavior plays a fundamental role in risk mitigation, being a forward-thinking leader in risk identification and ... strategy for identified US OBU business teams and functions by influencing senior management and other stakeholders to adhere to existing and evolving E&C principles… more
- Takeda Pharmaceuticals (Boston, MA)
- …scale-up, and troubleshooting of synthesis processes, ensuring robust pharmaceutical manufacturing through digital and in-silico methodologies. **ACCOUNTABILITIES:** ... implementing model-based design of experiments for process characterization and risk assessment. + Develops experimental designs and workflows for model… more
- Takeda Pharmaceuticals (Boston, MA)
- …R&D DD&T Portfolio and AF program leadership, ensuring streamlined communications, proactive risk management , and clear decision pathways + Partner with Pharm ... initiatives in R&D and shape the future of how Research and Pharmaceutical Science data, processes, and knowledge are harmonized across the value chain?… more
- Norstella (Boston, MA)
- …our customers come from over 3000 of the world's leading pharmaceutical , contract research organizations (CROs), medical technology, biotechnology and healthcare ... and development to regulatory approval, and from product launch to lifecycle management , we provide the intelligence and insight to help our customers seize… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities**… more
- Takeda Pharmaceuticals (Boston, MA)
- …risk assessment strategies for products. + Oversees signal detection and risk management activities for assigned products and ensures that development ... respect to compounds in development and marketed drugs, safety monitoring and risk management assessment and analysis. + Supports cross-functional team… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. ... new TLP, CCDS, USPI and EU SmPC. **How you will contribute:** ** Management of Labeling Cross-Functional Teams** + Leads Labeling cross-functional teams providing… more
- Integra LifeSciences (Braintree, MA)
- …related to integration of sterility and microbiological requirements during process and product risk management . + Review, assess, and update process and risk ... sterilization and microbiological processes are integrated into the overall process risk management process. **Regulatory Compliance & Documentation:** + Ensure… more
- Cognizant (Boston, MA)
- …especially with MES, digital, and process engineering teams. . Advanced problem-solving and risk management skills. . Demonstrated ability to define and enforce ... for client stakeholders and senior leadership regarding automation scope, progress, and risk mitigation . Collaborate with Program technical offices to ensure the… more