- Formation Bio (New York, NY)
- …Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating ... built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… more
- Formation Bio (New York, NY)
- …Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating ... built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… more
- Insmed Incorporated (NJ)
- …assessments and regulatory reports/submissions involving safety information.Experience in drug development and clinical trial methodology.Experience leading ... we're in. Are you?About the Role:We are seeking a highly experienced Senior Director , DSPV Medical Safety to help us expand what's possible for patients with… more
- Insmed Incorporated (NJ)
- …with FDA, EMA, and other global regulatory agenciesDeep understanding of the drug development processHighly organized with strong attention to detail, accuracy, ... global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other SPC Leadership Team members, and acts as back up support for Executive Director / Director of SPC Contract Development Responsible for authoring contract ... reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position… more
- Merck & Co. (Rahway, NJ)
- …learning and collaborative team environment. Required Skills and Experience: Experience in drug development or manufacturing, including process or analytical ... Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project… more
- Eisai, Inc (Nutley, NJ)
- …lifecycle management in both CTD format and non-CTD format.Experience of the Drug Development process and working with cross functional international/global ... and oncology, with a strong emphasis on research and development . Our history includes the development of...your profile, we want to hear from you. The Director , Global Regulatory, Growth Markets will be responsible for… more
- Insmed Incorporated (San Diego, CA)
- …(Pharm. D., Ph.D., MD/ MD equivalent preferred) with a minimum 5 years of drug development experienceExperience with EDC systems (ie, RAVE) and data analysis ... Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us expand what's possible for...You will provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug … more
- Tris Pharma (Monmouth Junction, NJ)
- …and quarterly reporting requirements for Federal and State programs including MDRP (Medicaid Drug Rebate Program ), Medicare Parts B and D, Public Health ... operational workflowsDeep working knowledge of government pricing regulations including MDRP (Medicaid Drug Rebate Program ), Medicare Part D, 340B, and VA… more
- Merck & Co. (Rahway, NJ)
- … development including regulatory submission and approval processes. Including development drug -device combination product or a medical device component ... Director Equivalent) Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine… more
