- Novo Nordisk Inc. (Irvine, CA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
- Medtronic (Northridge, CA)
- …Diabetes products and therapies to achieve regulatory approval and establish comprehensive clinical evidence, by optimizing clinical trial process, its ... in demonstrating collaborative behaviors and a boundary-less mindset. + Collaborate with senior management to establish clinical goals, strategies, plans and… more
- AbbVie (Irvine, CA)
- …submissions to health authorities (HAs), including Investigational New Drug (IND)/ Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure ... to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European… more
- Edwards Lifesciences (Irvine, CA)
- …the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience + The ... us and be part of our inspiring journey. As ** Senior Manager , Biostatistics** , you are responsible...+ Act as core team member/lead biostatistician of assigned clinical trial (s) in US and international/global … more
- Edwards Lifesciences (Irvine, CA)
- …Medical, and Regulatory Affairs Program Management Office, you will lead multiple cross-functional clinical trial programs and teams to plan, execute and drive ... the plan. + Scope: Understanding of product development process, clinical trial milestones, and strategic objectives to...Serve as a PMO lead in strategic conversations with senior internal and external personnel to inform business planning… more
- Medtronic (Anaheim, CA)
- …stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial design + Identify potential evidence gaps or risks to ... connected, compassionate world. **A Day in the Life** The Clinical Specialist will work with the new CathWorks System,...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Edwards Lifesciences (Irvine, CA)
- …of related work experience **What else we look for (Preferred)** : + Relevant clinical trial experience in medical device, biotech or pharma industry + ... longer and healthier lives. Join us and be part of our inspiring journey. The Manager , Clinical Portfolio Management (the formal Edwards title is Manager , … more