- Lilly (Indianapolis, IN)
- …behaviors to develop medicines with safety first and quality always. The Associate Director - Technical Services/Manufacturing Science (TSMS) Visual Inspection ... classification, control strategies, validation strategies, and personnel qualification strategies. The Associate Director - TS/MS Visual Inspection must balance… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism. The Associate Director Clinical Development, Oncology independently leads the ... on trials with quality, on time, and within scope and budget. The Associate Director consistently demonstrates leadership and influence throughout the trial… more
- Lilly (Indianapolis, IN)
- …days remote - a generous relocation package can be included with offer The ** Associate Director - Submission Data Delivery** role leads all aspects of global ... data archiving, data standards, and submission process. **Responsibilities:** The Associate Director -Submission Data Delivery provides technical leadership and… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Position Summary:** The Associate Director , Diagnostic Development will serve as the investigational in vitro ... diagnostic (diagnostic) trial-level expert for global clinical studies where approved diagnostics are needed to support the...+ Own the delivery of appropriate language for global study drug protocols when a diagnostic is included to… more
- Lilly (Indianapolis, IN)
- …clinical trial medicines, while also reducing costs and environmental impact. The Associate Director Process Engineering provides leadership and direction to the ... process flow documents, personnel qualification strategies, control strategies, technical studies , etc. + Interact with regulators, customers, or other outside… more
- Sumitomo Pharma (Indianapolis, IN)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study… more
- Lilly (Indianapolis, IN)
- …must be capable of using this expertise to enable very complex study designs driven by advanced randomization schemes, complex sourcing strategies, automated ... inventory methodologies, and data flow requirements. **Key Responsibilities:** ** Study Setup process management and oversight** + Partner with medical teams, key… more
- United Therapeutics (Indianapolis, IN)
- …Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic or pharma regulatory experience with a Master's ... sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or pharma regulatory...sciences, quality, regulatory affairs or a related area of study + 8+ years of project or people management… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and/o academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 ... Acts as the signatory on NDA submissions and clinical study and safety documents. + Involved in product life...prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced… more
- Lilly (Indianapolis, IN)
- …Synthesis and Purification / Small Molecule]_ reports to the API EM Engineering Associate Director and provides technical leadership and expertise in conjunction ... operational incidents. + Peer review documentation of learning points, technical studies , and incident investigations. **Develop and Sustain Process Knowledge** +… more
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