- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …drug products, and drug-device combination products. + Determine regulatory and scientific /technical requirements for CMC and GMP related submissions and inquiries. ... authorities to assure compliance with regulatory, company standards and scientific /technical requirements. + Develop and execute regulatory strategies for post… more
- BeOne Medicines (San Mateo, CA)
- …in global working environment is a must-have. * Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development ... (upstream, downstream, formulation, analytical, manufacturing, QC, QA, etc.). * Experience in gene/cell therapy or/and medical device is a plus. * In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality… more
- Abbott (San Diego, CA)
- …study design and protocols. + Assures that clinical research program design meets scientific objectives and is aligned with commercial needs. + Ensure all clinical ... trials comply with Good Clinical Practice (GCP) guidelines and relevant regulatory standards. + Manage clinical trial budgets, timelines, and resources effectively to ensure successful trial completion. + Establishes the conditions essential for determining… more
- Edwards Lifesciences (Irvine, CA)
- …related experience **What else we look for (Preferred):** + Degree in scientific discipline (eg, Biology, Microbiology, Chemistry) + Experience in preparing domestic ... and international product submissions + Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel + Excellent written and verbal communication skills including negotiating and relationship management skills + Excellent problem-solving,… more
- Astrix Technology (CA)
- ** Scientific Professionals** Science & Research United States, CA, US Pay Rate Low: 20 | Pay Rate High: 100 + Added - 06/06/2024 Apply for Job Astrix has been ... Control, Quality Assurance, Quality Systems, Document Control + Regulatory Affairs + Laboratory Personnel (Chemists, Microbiologists, Lab Technicians, Lab… more
- Bristol Myers Squibb (San Diego, CA)
- …The Senior MSL will proactively build healthcare provider support by employing a scientific approach that aligns with medical affairs objectives and the ... purpose of the interactions with the KOL/HCP is to engage in appropriate scientific exchange that will ensure that patients have access to RayzeBio clinical trial… more
- Cardinal Health (Sacramento, CA)
- …in compliance programs and processes. **Qualifications** + Bachelor's degree in scientific or compliance field, eg, Legal, Regulatory Affairs , Engineering ... internal and external regulatory policies. Leverage broad knowledge of regulatory affairs , quality management systems and business operations to develop regulatory… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and protocols. + Develops focused expertise to serve as an clinical/medical scientific consultant to health economic, medical affairs , marketing, regulatory, ... Consults with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully applies their recommendations toward optimizing trial… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and protocols. + Develop focused expertise to serve as a clinical/medical scientific consultant to health economic, medical affairs , marketing, regulatory, ... + Consult with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully apply their recommendations toward optimizing trial… more
- Sumitomo Pharma (Sacramento, CA)
- …Biometrics, Regulatory, Early Clinical Development, Pre-clinical research, Medical Affairs and Commercial functions. The VP Clinical Development, Oncology ... will need deep expertise in Oncology with strong leadership skills, scientific rigor, and the ability to collaborate effectively with cross-functional teams.… more