- Genmab (NJ)
- …Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data ... oversight of relevant programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP)… more
- Formation Bio (New York, NY)
- …strategies that identify and address potential quality risks. Managing quality -related activities related to manufacturing, clinical trials, and nonclinical ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...are seeking a highly accomplished, strategic Vice President of Quality Assurance. In this pivotal role, you will have… more
- Formation Bio (New York, NY)
- …Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Aequor (Thousand Oaks, CA)
- …Range The Process Documentation Management CW is responsible for delivering quality leadership in process documentation for significant internal change initiatives. ... This role provides clear quality requirements for process documents, exemplifies strong partnership skills,...o Document and process management experience o Change management expertise o Clinical Trial experience and/or knowledge of ICH… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Supplies and Development Batches to meet Clinical Development Program requirements.-Partners with Quality , Operations, Technology, and ... or acceptable related experience.-Required Experience and Skills:-Strong familiarity with Quality , cGMP, Safety & Environmental Policies and Procedures.Demonstrated technical… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Novo Nordisk Inc. (Charlotte, NC)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....a difference? The Position Builds relationships and demonstrates the clinical outcome and benefits of NNI products. Educates and… more
- Eisai, Inc (Nutley, NJ)
- …looking for a scientifically driven imaging expert with deep knowledge of Oncology clinical trials to shape the future of imaging science across its development ... of imaging acquisition strategies, biomarkers, and advanced analytics to support translational and clinical goals. At the same time, they will ensure data quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development and … more
