- Sumitomo Pharma (Sacramento, CA)
- …in bringing clinical molecules to successful commercial products within different Global Markets, including leading regulatory filings. + Successfully executed ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...Pharma Switzerland GmbH) focused on addressing patient needs in oncology , urology, women's health, rare diseases, psychiatry & neurology,… more
- BeOne Medicines (Emeryville, CA)
- …economic and outcomes research in the oncology space + Familiarity with global regulatory and medical affairs environments (eg, US, EU, APAC) + Experience ... We are seeking a highly experienced and strategically minded Medical Writer to lead the tactical execution of publications stemming from our global medical… more
- Bristol Myers Squibb (San Diego, CA)
- …a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Director, Medical Affairs Research Operations, ... will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and Legal).… more
- Bristol Myers Squibb (San Diego, CA)
- …brochures, clinical study reports, and review of other clinical trial and regulatory documents + Conduct investigator meetings and lead site qualification ... with clinical trial investigators and thought leaders + Serve as clinical lead for regulatory interactions, including preparation of briefing documents and… more
- AbbVie (Irvine, CA)
- … regulatory submissions and responses and other program documents. Lead development, validation, and justification of new clinical outcome assessment instruments ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (Irvine, CA)
- …authoring regulatory submissions, and responding to regulatory questions across global markets. + Lead across functions within project teams to deliver ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...develop scientists into future leaders + Demonstrated experience with global regulatory expectations and regulatory … more
- Amgen (Thousand Oaks, CA)
- …area to a range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development ... of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents + Lead the evidence generation strategy as well… more
- AbbVie (San Francisco, CA)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight… more
- Amgen (Thousand Oaks, CA)
- …quality systems. + Ensure site's process validation business process adheres to global regulatory agency standards, Amgen's quality requirements, other site ... the world's toughest diseases. With our focus on four therapeutic areas - Oncology , Inflammation, General Medicine, and Rare Disease- we reach millions of patients… more
- Sumitomo Pharma (Sacramento, CA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology , urology, women's health, rare diseases, psychiatry & neurology, and cell &… more
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