- Gilead Sciences, Inc. (Foster City, CA)
- …digital tools and analytics per our **Quality digital roadmaps** **Compliance & Regulatory Affairs ** + Ensure site-wide compliance with cGMP, FDA, EMA, ... ICH, and other applicable regulations. + Comfortable representing the company to **health authorities** ; able to navigate challenging audit situations-capabilities explicitly called out in our QA career paths. **Operational Oversight** + Oversee Quality… more
- Kelly Services (South San Francisco, CA)
- …standard operating procedures. * Collaborate cross-functionally with Biostatistics, Clinical R&D, Regulatory Affairs , and Data Management to support study ... clinical study reports, and publications. * Act as programming lead for regulatory deliverables, ensuring alignment with ICH, FDA, EMA guidance, and internal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** Reporting to the SVP of Global Regulatory Affairs , Patient Safety and Quality, the VP of R&D Quality will ... the vision, recommendations and execution of the worldwide R&D and Medical Affairs quality strategy as an independent and objective function for all investigational… more
- Terumo Neuro (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues ... 4. Manage large scale project(s) or multiple smaller scale projects and timelines with some guidance 5. Communicate project status and issues in a timely, clear, and appropriate manner to the organization 6. Analyze and/or direct the analysis of research data… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …**Engage in cross-functional collaboration** : Attend and contribute to meetings with Regulatory Affairs , Commercial, and other departments to gain insight into ... the broader drug development and lifecycle management processes. + Showcase your work with a final presentation (PPT) near the conclusion of your internship **Required Qualifications:** + Must be at least 18 years old + Must have a minimum GPA of 2.8 +… more
- Envista Holdings Corporation (Pomona, CA)
- …+ Effectively collaborate with multiple departments such as logistics, trade compliance, regulatory affairs , supply chain, and sales when needed to resolve ... customer issues. + Create and maintain customer accounts. + Attend, understand, and actively participate in daily department Key Performance Indicator (KPI) meetings. + Attend required department training courses on and offsite when needed. + Creates and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical Development to ensure ... as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +...and drug product. + Proven track record in drafting regulatory documentation at all stages, including **IND, BLA, and… more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Prime Healthcare (Lynwood, CA)
- …criteria are met and up to date; attend administrative meetings related to regulatory affairs ; implement/change operations based on State and Federal regulations ... and any other functions concerned with patient care and operations of the Pharmacy consistent with policies and procedures of the hospital and State and Federal laws. Outpatient- The Pharmacy Supervisor will serve as the Pharmacy Manager and Pharmacist in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …communication skills (up, down, and outward) **Preferred Qualifications:** + Experience in Regulatory Affairs preferred. + Experience in metrics, data analytics, ... field (Engineering, Science, Math/Stat) + Minimum 10 years experience in Quality, Regulatory , or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.… more