- Sanofi Group (Cambridge, MA)
- …stakeholders - in support of Sanofi's vision for modernization and transformative clinical innovation. We are an innovative global healthcare company with ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Oracle (Boston, MA)
- …& Risk Awareness: Ensure that Clinical AI Agents meet healthcare industry standards for data privacy, transparency, and reliability. + Customer Engagement & ... Coordinate the training, tuning, and evaluation of models-ensuring alignment with clinical intent, performance benchmarks, and compliance standards . + Validation… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/ global (if applicable) regulatory requirements. **Key ... may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured,...(eg, Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant… more
- Sumitomo Pharma (Boston, MA)
- …knowledge and ability to comply with all relevant ethical, regulatory, and legal standards . + May participate in or lead clinical development contributions to ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...experienced individual for the position of **Associate** **Medical Director, Clinical Development - Oncology** . The associate medical director… more
- Oracle (Boston, MA)
- …output quality, driving continuous improvement in healthcare solutions. + Analyze mappings between clinical data standards and EMR systems (eg, Cerner), ... Hands-on experience with EMR systems (eg, Epic, Cerner, Athenahealth) + Familiarity with healthcare data standards (eg, SNOMED CT, ICD) and a keen interest in… more
- CSL Behring (Waltham, MA)
- …therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position ... a week. You will report to the Director of Clinical Assay. You will be part of a specialized...assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding… more
- CSL Behring (Waltham, MA)
- …therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position ... a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will be part...assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and… more
- Takeda Pharmaceuticals (Boston, MA)
- …leadership and scientific direction on medical evidence activities in order to: + Set standards for utilization of medical data . + Maximize patients' access to ... rare diseases, growth and launch brands. Partners with the Global Program Team (GPT) Evidence Generation sub team (a...collaboration between various groups within Takeda through sharing of data and best practices; + Prepare and review research… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. **How you will contribute:** + As… more