- GRAIL (Boston, MA)
- …leading global investors and pharmaceutical, technology, and healthcare companies. For more information , please visit grail.com . The role assists with regulatory ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- CSL Behring (Waltham, MA)
- …a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will be part of a specialized non-laboratory based team and ... data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a… more
- CSL Behring (Waltham, MA)
- …position and is onsite three days a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will be part of a specialized ... data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a… more
- Parexel (Boston, MA)
- …works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a ... and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents… more
- Parexel (Boston, MA)
- …works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a ... and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... + Interface with the study team as needed, facilitate information flow between members of the study team, vendors...development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...regulatory submissions and responses to health authority (HA) information requests. In addition, this position may represent GRA… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will ... application process with Takeda will commence and that the information I provide in my application will be processed...be part of the global regulatory team. As Associate Director ,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... application process with Takeda will commence and that the information I provide in my application will be processed...medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's… more
