- Takeda Pharmaceuticals (Cambridge, MA)
- …will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize their technical expertise to contribute across multiple ... complex projects with extraordinary technical challenges and applies strong technical risk assessment skills. + Owns a discipline/technical skill in its entirety… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …This role requires a minimum of 8 years of experience in the pharmaceutical industry, specifically in Quality Management Systems (QMS), using tools such ... and manage validation and QA activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements… more
- AbbVie (Waltham, MA)
- …sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management . Leads the collection, verification and ... Management , Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with… more
- Adecco US, Inc. (Cambridge, MA)
- …is a plus. + **7+ years' experience** in technical project management , pharmaceutical development, technical operations, and/or manufacturing of small-molecule ... the **MSAT Synthetics and Oral Solids** group, supporting **CMC development and pharmaceutical technical activities** for new R&D compounds, Life Cycle Management… more
- Takeda Pharmaceuticals (Boston, MA)
- …implementing model-based design of experiments for process characterization and risk assessment. + Lead and develop experimental designs and workflows ... predictions. + Review, interpret and communicate data cross functionally within pharmaceutical sciences and project teams. + Significant technical responsibility for… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management . + Knowledge and understanding of ... committees. + Ensure communication of all safety information that may impact the benefit- risk profile of assigned products to senior management . + Provide… more
- Merck (Cambridge, MA)
- … Management , Benefits Management , Drug Discovery Process, Management System Development, Pharmaceutical Sciences, Pharmacokinetics, PKPD Modeling, Product ... Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and implementing procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, ... of the Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure alignment with Company… more
- Takeda Pharmaceuticals (Lexington, MA)
- …programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive product training frameworks, ... benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management :** + Develop Device Clinical Development Strategy… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …ensuring the effectiveness of global systems. This role will also encompass document management , learning and development, risk management , data integrity ... ideal candidate will have a strong background in quality management within the pharmaceutical industry and a...to monitor Quality performance and drive data-driven decision-making. Maintain risk management toolkit and best practices. +… more