- BeOne Medicines (San Mateo, CA)
- …sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications. + Develop ... lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. + Provide… more
- BeOne Medicines (Pennington, NJ)
- …role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities. **Essential Functions:** + Serve as MST ... data and metrics driven culture. Relentlessly maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs ... process improvements and contributes to local and / or global process improvements, which have a significant impact for...assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs. + Must… more
- Lilly (Lebanon, IN)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... the successful candidate will help to start up the facility for both clinical and commercial supply. **The Manufacturing Operations / Launch Lead** will be… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds,… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for a direct hire opportunity with a leading ... Senior Director , $275,000 - $320,000 **Overview** As Associate Director / Director , Drug...process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success. You'll thrive as part of… more
- IQVIA (Washington, DC)
- …is seeking a strong In-House CRA to join our Clinical team. The In-House Clinical Research Associate will be a critical team member reporting directly to the ... Director of Clinical Affairs, to support ...trial operations for the firm's clientele.** **Position Overview** **The Clinical Trial Associate (CTA) supports the In-House… more
- Mount Sinai Health System (Brooklyn, NY)
- …by review of rounding validation data and observation of unit rounding. 5. Validates Associate Director / Clinical Nurse Manager competency in PHR and provides ... the goals of the organization. 3. Works collaboratively with Associate Director / Clinical Nurse Manager/Assistant...knowledge and skills relative to the role, patient population, clinical specialty and global or local health… more
- St. George's University (Great River, NY)
- …efficiency, and regulatory compliance. The Director directly manages the Senior Associate Director , Financial Aid Operations and Training, Associate ... Registrar of Academic Enrollment and Compliance and the Associate Director of Financial Aid Operations and...and incoming students. + Collaborate with Registrar, Bursar, and Clinical Education Operations to ensure financial aid and enrollment… more
- Lilly (Indianapolis, IN)
- …Director (M3/M3-2), CT Manufacturing and Materials Management **Reporting to:** Associate Vice President (M4), Clinical Material Delivery **Organization ... to the right patient at the right time, every time. This ever-evolving global organization delivers clinical trial (CT) materials with the technical expertise,… more
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