- BeOne Medicines (Emeryville, CA)
- …study/project teams supporting hematology studies and interact with Clinical, Regulatory , Statistical Programming, Data Management and other Research Scientists in ... meet analysis requirements, internal standard operating procedures, and external regulatory requirements. + Analyzes data and interprets results from clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports ... + Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance...this role. **Minimum Education & Experience** + PharmD / PhD with 2+ years' relevant clinical or related experience… more
- Pfizer (South San Francisco, CA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Merck (South San Francisco, CA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Bayer (Berkeley, CA)
- …processes and logistics with regard to safety, environment, cost, quality and regulatory requirements; * Provides technical input for the definition of concepts for ... Systems per Bayer directives, CFR Part 11 and other regulatory agency requirements. **WHO YOU ARE** Bayer seeks an...6+ years (YOE preferred), MS 0-4+ years (YOE preferred), PhD 0-2 years (YOE preferred) experience in industrial automation,… more
- Bayer (Berkeley, CA)
- …processes and logistics with regard to safety, environment, cost, quality and regulatory requirements; * Provide key technical input for the definition of concepts ... of risk analysis; * Understand relevant SOPs, Guidelines and Regulatory requirements. **Other** * Coach and teach junior members...related field. + BS 8+ years, MS 2-6+ years, PhD 0-4 years or an equivalent combination of education… more
- Amgen (Thousand Oaks, CA)
- …range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one ... of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents + Lead the evidence generation strategy as well as… more
- Bristol Myers Squibb (San Diego, CA)
- …data to support development + Serving as principal functional author for Regulatory submission, study reports, and publications + Provides oversight and medical ... of the literature + Keeps abreast of development and regulatory issues related to other competitive or relevant compounds...**Degree Requirements** + Advanced degree(s) in relevant field: MD, MD/ PhD (or x-US equivalent) and clinical expertise in a… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …comply with current Good Manufacturing Practices (cGMPs), company policies, and regulatory requirements. + Sponsor and oversee process improvements and harmonization ... facilities and equipment are maintained for valuation and continuous improvement, meeting regulatory and compliance expectations. + Serve as the SME leader for… more
- Abbott (Santa Clara, CA)
- …all the new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 ... on risk assessments (products/materials, impurities, leachables and extractables), author regulatory documents, and interact with Health Authorities. + Responsible… more