- Gilead Sciences, Inc. (Foster City, CA)
- …and what needs improvement. + Work with therapeutic area authors, legal, regulatory , and other stakeholders to ensure content is created and delivered effectively. ... Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience **Preferred Qualifications:** + Advanced scientific degree… more
- Amgen (South San Francisco, CA)
- …to optimize dose selection and preclinical study designs. + Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and ... is a subject matter expert with these qualifications. **Basic Qualifications:** Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 4… more
- BeOne Medicines (San Mateo, CA)
- …of Clinical Pharmacology activities, including tasks related to non-compartmental analysis (NCA), data visualization, table generation, quality control (QC) of ... Health Authority responses, or Marketing authorization/NDA/BLA submissions: + Non-Compartmental Analysis (NCA): + Perform NCA to characterize the pharmacokinetics of… more
- Edwards Lifesciences (Irvine, CA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... + Leading a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation + Providing technical and strategic leadership… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …standard + Draft and review of CMC sections and supporting documents for Regulatory filings. Participate in PAI, defend regulatory audits and draft responses ... lead others + Expertise with analytical method development and qualification and analysis of cell therapy productsWell versed in various analytical techniques such… more
- Amazon (Sunnyvale, CA)
- …establish testing protocols, manage certification processes, and interface with regulatory bodies. Beyond compliance, the engineer proactively shapes the safety ... in this role involves working with cross-functional and outside partners on regulatory compliance initiatives, connecting with our product development team to drive… more
- Fujifilm (Santa Clara, CA)
- …this level. **Job Complexity:** Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises ... degree; or 8 years and a Master's degree; or PhD with 5 years experience; or equivalent experience. **Company...to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for purification technology development, platform process evolution, and support of regulatory filings. We are seeking a highly motivated, team-oriented individual ... including design of experiments, process optimization, data interpretation and analysis Responsible for technology transfer to manufacturing facility and provide… more
- Astellas Pharma (South San Francisco, CA)
- …to supervisor and technical teams. + Keep current with all regulatory guidelines, compendia requirements, scientific publications, and technical innovations. + ... + This position requires onsite work. **Required Qualifications:** + PhD with 3+ years, or MS with 8+ years,...to QC and manufacturing consistent with project timelines and regulatory expectations. + Prior history in compiling and analyzing… more
- Pfizer (South San Francisco, CA)
- …with Asset Teams to manage the timely testing of clinical trial samples and the analysis and reporting of the associated data **MNIMUM QUALIFICATIONS** + PhD in ... of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and Dx… more