- Lilly (Indianapolis, IN)
- …drug development. The Foundry's mission is to accelerate innovation, expand clinical trial capacity, expedite the delivery of new medicines, and reduce costs and ... environmental impact. The Process Translation and Execution (PTE) team drives scientific excellence and innovation to accelerate manufacturing advancements. The team translates API/DS process knowledge into clinical supply readiness, oversees technology… more
- Boehringer Ingelheim (Ridgefield, CT)
- …sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and ... the organization. **Duties & Responsibilities** * Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. * As part of the… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …the biotechnology and pharmaceutical industry. Deep experience in clinical development, trial design statistical principles is essential. Excellent oral and written ... communication skills. Strong critical thinking and problem solving skills. Excellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials. Ability to work cross-functionally to effectively implement and oversee… more
- Gilead Sciences, Inc. (Foster City, CA)
- …capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical ... trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions + Lead new quality focused initiatives… more
- Lilly (Indianapolis, IN)
- …to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. **Responsibilities:** ... + Collaboratively define and develop the enterprise data management strategy for the Medicine Foundry, establishing governance frameworks, architectural standards, and data policies that enable automated, paperless, and fully integrated operations + Maintain… more
- Regeneron Pharmaceuticals (Troy, NY)
- …leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, ... combination products, and/or small molecule drugs. + Previous experience with device regulatory requirements and development processes for combination products is an advantage. + Human Factors experience is a plus. + Experience in dealings with the FDA and… more
- ThermoFisher Scientific (Wilmington, NC)
- …research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve ... health outcomes that people and communities depend on - now and in the future.** **Location/Division Specific Information:** Join Thermo Fisher Scientific as a Global Medical Safety Lead Physician(FSP) based in the United States and be part of a world-class… more
- Pfizer (South San Francisco, CA)
- …clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results + ... Support execution for all FIH programs through proof-of concept + Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discusse relevant data to appropriate… more
- AbbVie (Irvine, CA)
- …a global scientific and business strategy. *Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and ... experience in development of clinical strategy and the design of study protocols. *Must possess excellent oral and written English communication skills. *Ability to exercise judgment and address complex problems and create solutions for one or more projects.… more
- ThermoFisher Scientific (Wilmington, NC)
- …research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve ... health outcomes that people and communities depend on - now and in the future. Evidera's Patient-Centered Research (PCR) group is responsible for patient experience and insight research to support product development. Our work has helped identify and clarify… more