- Sumitomo Pharma (Sacramento, CA)
- …for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs ... (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre- clinical research, Medical Affairs and Commercial… more
- Bausch + Lomb (Sacramento, CA)
- …members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs and/or CTMs… more
- J&J Family of Companies (Irvine, CA)
- …collaborating with multiple cross-functional partners including Marketing, Medical Affairs , Clinical Teams, Regulatory Affairs , and Sales Leadership. ... n-BCA Liquid Embolic System and Enterprise Vascular Reconstruction Device with Clinical Affairs , Regulatory , and Legal teams. + Oversee development and… more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational ... Experience working with and solid understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-… more
- BeOne Medicines (San Mateo, CA)
- …our dynamic team. The ideal candidate will have a strong background in research, clinical development, regulatory affairs , and safety, with a particular ... a focus on R&D. + Proven expertise and understanding of research, clinical development, regulatory affairs , and safety processes, workflows and analytics. +… more
- BeOne Medicines (Emeryville, CA)
- … clinical development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs , and Clinical Development to ... analyses, including covariate modeling, visualization, and interpretation to inform clinical and regulatory strategy. . Ensure high-quality, compliant,… more
- Terumo Neuro (Aliso Viejo, CA)
- … clinical reports, documents and scientific presentations in cooperation with the Clinical , Medical, & Regulatory Affairs Teams, KOLs and physician ... external deliverables. Some typical job duties include: + Collaborating with the clinical & regulatory teams to write clinical documents for regulatory … more
- Roche (South San Francisco, CA)
- … and scientific best practices + Partner closely with senior leadership across PD-DSA, clinical development, regulatory affairs , and data science teams to ... primary liaison between the Biostatistics function and key stakeholders across Clinical , Regulatory , and Data Science teams to drive alignment and shape outcomes… more
- AbbVie (South San Francisco, CA)
- …(eg, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical ... + Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory... regulatory agencies and responses to requests from regulatory agencies. + Attend regulatory meetings. +… more
- J&J Family of Companies (Santa Clara, CA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Description:** Johnson & Johnson is hiring for a **Manager, Regulatory Affairs - Shockwave Medica** l to...both internally with cross-functional teams and externally with various regulatory agencies. + Evaluate proposed design, clinical … more
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