- Deloitte (San Jose, CA)
- …a digitally enabled, equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND,… more
- Edwards Lifesciences (San Francisco, CA)
- …Our other star player? You! IHFM has achieved a significant milestone and received FDA approval for our Cordella PA Sensor. Join us as we commercialize this ... revolutionary heart failure management system! As the Area Sales Manager at IHFM, you will play a pioneering role in driving the adoption and growth. You will lead… more
- Bio-Techne (San Jose, CA)
- …to perform in ways that far exceeds what is delivered today. As a technical manager operating in a leadership role, you will be empowered to ensure the team(s) ... environment Working knowledge of python programming language Understanding of GAMP5, FDA , and ISO regulations preferred. **Why Join Bio-Techne:** **We offer… more
- ZOLL Medical Corporation (Santa Rosa, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... a minimum of 1 year OR have successfully performed within a Associate Territory Manager role. Physical Demands + This position requires the employee to sit, stand,… more
- Abbott (San Jose, CA)
- …to restore their health and get on with their lives. The Territory Manager position is a sales opportunity in the CardioMEMS business responsible for achieving ... travel plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, processes,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …interprets these. + Thorough knowledge of Food & Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable national regulations, International ... Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies. + Familiar with standard medical / scientific terminology. + Ability to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Agile delivery experience + Track record working in a fast paced, FDA regulated IT environment + Experience managing consultants and providing technical ... recommendations + Ability to work independently and manage multiple projects & priorities + Excellent written and verbal communication skills The salary range for this position is: Bay Area: $146,540.00 - $189,640.00. Raleigh: $126,565.00 - $163,790.00. Gilead… more
- Insight Global (San Diego, CA)
- …of IT experience working in a pharmaceutical company with exposure to FDA regulations. * Experience supporting validation applications for regulatory purposes in a ... biotech/pharmaceutical company * Technical experience and knowledge of Microsoft applications utilizing the following technologies: MS SQL Server, Oracle, JAVA, Visual Basic, MS Access, MS Project, IIS, Internet Explorer, and * Experience with Advanced Web… more
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more