- Terumo Neuro (Aliso Viejo, CA)
- …the medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum of responsibilities including ... conducting clinical research audits (sponsor, site, vendor, process, function, and systems);...process, function, and systems); preparing for and hosting external regulatory inspections (eg, mock BIMO, BIMO, for cause, etc.);… more
- Genentech (South San Francisco, CA)
- …innovative biomarker technologies to accelerate clinical development and translational research strategic goals in Translational Medicine (TM). The position will** ... control over 3-5 people leaders, supporting therapeutic molecules and translational research activities across the gRED and Product Development portfolio.** **This… more
- Amgen (South San Francisco, CA)
- …patient subpopulations. + **Cross-Functional Collaboration:** Partner with Discovery Research , Clinical Pharmacology, Toxicology, Early Development, and ... you'll help make a lasting impact on the lives of patients as we research , manufacture, and deliver innovative medicines to help people live longer, fuller happier… more
- Astellas Pharma (South San Francisco, CA)
- …connect small ideation teams, identify promising seeds, and manage incubation research effort to create drug discovery projects (DC) while promoting collaboration ... biologics functions. The lead will oversee two or more incubation research projects simultaneously. **Essential Job Responsibilities:** **Strategic Leadership** + As… more
- Astellas Pharma (South San Francisco, CA)
- …connect small ideation teams, identify promising seeds, and manage incubation research effort to create drug discovery projects (DC) while promoting collaboration ... functions. The lead will oversee three or more incubation research projects simultaneously. **Essential Job Responsibilities:** **_Strategic Leadership_** + As… more
- AbbVie (Irvine, CA)
- …advance medicines to our patients. Responsibilities: + Provide expertise/lead regulatory submission and product life-cycle management strategy planning and ... for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product… more
- Kelly Services (South San Francisco, CA)
- …of CMC, you'll be instrumental in overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success. ... oligonucleotide drug substances, supporting clinical and eventual commercial launches. + Regulatory Contribution: Author and review IND/IMPD and other relevant … more
- AbbVie (South San Francisco, CA)
- …of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting ... for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans. + Represent function/department on project… more
- J&J Family of Companies (San Francisco, CA)
- …landscape trends in their therapeutic areas of interest. The Sr. MSL provides research support for company and investigator initiated research . The Sr MSL ... Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines. This is a field based clinical… more
- Abbott (Alameda, CA)
- …of the study protocols. They are responsible for maintaining comprehensive research documentation for audits, inspections and regulatory submissions. Develop ... or related field. + Minimum 6 years in clinical research or related field. + Education and work experience...data collection best practices for clinical trials familiarity with regulatory frameworks (eg, FDA, EMA, ICH-GCP). + Knowledge of… more