- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education Level Bachelor's degree required; relevant experience may substitute for degree, when appropriate; advanced degree preferred Experience Level Requires 8+ ... years of progressively responsible related experience, with at least 4 years in area of specialty; pharma experience preferred Specific or technical job skills Strong Root Cause Analysis and CAPA development skills. PV experience/knowledge preferred Excellent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education Level: Bachelor's degree required (healthcare provider required); relevant experience may substitute for degree, when appropriate; advanced degree preferred ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education Level: Minimum Bachelor's degree required (healthcare provider required); relevant experience may substitute for degree, when appropriate; advanced degree ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies… more
- Tris Pharma (Monmouth Junction, NJ)
- …out responsibilities in accordance with company policies, SOPs, and state, federal and local laws Performs validation of analytical methods and release/stability ... testing for raw materials, IP, FP and ST samples of pilot/pivotal/submission batches using High Pressure Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared… more
- Tris Pharma (Monmouth Junction, NJ)
- …in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local lawsSets up and operates analytical instruments (ie, High ... Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, dissolution apparatus, etc.) to support sample testing Performs all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Merck & Co. (Upper Gwynedd, PA)
- …Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for planning and management ... of an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modelling colleagues across the organization to translate the benchtop science of preclinical discovery into compounds ready for… more
- Merck & Co. (Upper Gwynedd, PA)
- …certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for ... annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid… more
- Merck & Co. (Upper Gwynedd, PA)
- …Must have experience in industry or senior faculty in academiaMinimum of 3 years of clinical medicine experienceMinimum of 3 -5 years of industry experience in drug ... development or biomedical research experience in academiaDemonstrated record of scientific scholarship and achievementA proven track record in clinical medicine and background in biomedical research is essentialStrong interpersonal skills, as well as the… more
- Merck & Co. (North Wales, PA)
- …certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for ... annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid… more
- Merck & Co. (North Wales, PA)
- …The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.Lead a ~250+ organization responsible for either ... the non-sterile or sterile manufacturing processes in a 24/7 operation and be responsible to assign personnel to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring,… more
- Merck & Co. (North Wales, PA)
- …for a specific compound or trialEnhances the comprehension of the scientific foundations and goals of investigator-sponsored researchIdentifies barriers to patient ... enrollment and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site… more
- Merck & Co. (North Wales, PA)
- …include:Collaborating cross-functionally in the development of Protocol and related study materials (eg, ICF documents / amendments); Partners with the Study Manager ... Job DescriptionJob SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific… more
- Merck & Co. (North Wales, PA)
- …certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for ... annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid… more
- Merck & Co. (North Wales, PA)
- …certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for ... annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid… more
- Merck & Co. (North Wales, PA)
- …Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary ... area of responsibilities will include:Project support for System Development, Maintenance, Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …Be able to work independently under minimal supervision.Lead, design and optimize research with aims of exploring next generation cell therapies using in-vivo CAR ... virusPerform functional characterization of T cells transduced with in-vivo CAR virus using multiple functional assays but not limited to cytotoxicity assay, serial cytotoxicity assay, and cytokine release assay etc.Help execute the evaluation of in-vivo CAR… more
- Merck & Co. (North Wales, PA)
- …certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for ... annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid… more
- Merck & Co. (North Wales, PA)
- …Responsible for the operational planning, feasibility, and execution of a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, ... development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator-meeting planning, communication plans, preparation of status update reports, study close… more
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