- AbbVie (North Chicago, IL)
- …regulatory submission documents. Maintain awareness of global regulatory requirements on pharmaceutical development . Ensure necessary changes to regulations are ... that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provides drug development experience and advice to… more
- J&J Family of Companies (Raritan, NJ)
- …product labeling/labeling regulations, or equivalent is preferred. + An understanding of pharmaceutical drug development is required. + Experience in discussing ... Product Leader will be responsible for the following: + Lead the development , revision, review, agreement, and maintenance of primary labeling (Company Core Data… more
- Amgen (Thousand Oaks, CA)
- …and a balanced, realistic understanding of issues + Knowledge of pharmaceutical product development , product lifecycle, and commercialization processes, ... Executive Medical Director, US Medical Affairs Lead, you will be accountable for the development and execution of the US medical affairs strategy for the Thyroid Eye… more
- Gilead Sciences, Inc. (Foster City, CA)
- …responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. **JOB DESCRIPTION** ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- Lilly (Philadelphia, PA)
- …role in discovering and developing imaging agents that guide and transform precision pharmaceutical development in neuroscience and oncology for a company with ... oversee licensing and provide technical expertise and operational support in the development , implementation and maintenance of radiation use at the site to achieve… more
- IQVIA (Durham, NC)
- …teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for ... lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the… more
- Sanofi Group (Morristown, NJ)
- …(SDTM, SDRG, ADRG, ADAM, XML format, etc.); thorough understanding of pharmaceutical clinical development (ie statistical concepts, techniques and clinical ... the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in… more
- Merck (West Point, PA)
- …5 compounds is a plus. . **New Product Introductions** - Knowledge of Pharmaceutical product development and commercialization. Awareness of MDCP development ... molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical , Biologic, and Vaccine Products. Our team works with a "Safety… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …databases and experience working with complex data systems. + Experience in pharmaceutical clinical development and ability to provide programming support and ... and annual reports. If applicable, programming representative for an application development to the user audience. + Develop data models, programming standards… more
- Xcelerate Solutions (Frederick, MD)
- …management plans to ensure compliance with regulation + Monitor EVMSs appropriate for pharmaceutical development and within the constraints of the FDA approval ... acquisition advisors and partners in the Medical Countermeasure product development space to develop synchronized, executable regulatory and acquisition strategies… more