- Merck (Boston, MA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... or a related field + At least 10 years of discovery/ drug development/ regulatory experience + Deep expertise in pharmacometrics (eg, population PK and… more
- J&J Family of Companies (Titusville, NJ)
- …/ DETAILED DUTIES:** + Assists Regulatory Affairs in the development of drug regulatory strategies + Helps explore and evaluate new product ideas to ... for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …reporting of clinical pharmacology studies. + Extensive experience in late-state drug development, regulatory submissions and life-cycle management. + Hands-on ... sciences, pharmacometrics, statistics and programming). + Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation… more
- Catalent Pharma Solutions (Chelsea, MA)
- …quality of final products. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 4 years of experience in job offered or ... Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according… more
- Merck (Rahway, NJ)
- …+ Experience with sterile GMP facility startup. + Knowledge of Investigational drug regulatory requirements. + Understanding of Clinical Supply Chain Operations. ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Otsuka America Pharmaceutical Inc. (Charleston, WV)
- …pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages **.** + Lead **clinical ... + Interact cross-functionally across other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … submissions and/or national or international presentations + Excellent understanding of drug development, regulatory processes and clinical development + Strong ... Translational sub team (TST) partnering with Gastro-Intestinal & Inflammation drug discovery unit (GI2-DDU) research scientists, Gastro-Intestinal & Inflammation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and experience in one or more of the following areas: + Experience in drug development, authoring documents for regulatory authorities + Deep understanding of ... is to design and conduct or monitor experiments to understand the metabolism and drug - drug interaction (DDI) properties of drug candidates, particularly the… more
- Lilly (Indianapolis, IN)
- …has an expanding and diverse portfolio of ADCs that require thorough drug -linker process development and regulatory submission strategies, often with compressed ... accelerate the development of lifesaving new medicines for our patients. Our antibody- drug conjugate (ADC) team seeks to perform innovative and cutting-edge research… more
- Merck (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... **Position Specific Required Skills and Experience:** + US and/or worldwide drug or vaccine regulatory application submission experience including the… more