- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research ... contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated... research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA ( Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases ... of a clinical research study, taking responsibility of allocated...( Clinical Research ) experience may include Clinical Trial-Assistant, Study Coordinator, Regulatory CTC (… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team… more
- Merck & Co. (Rahway, NJ)
- …Associate Principal Scientist position available at its Kenilworth, New Jersey research facility.- The Associate Principal Scientist is a laboratory-based ... Job DescriptionOur Research Scientists are our Inventors. We identify and...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). Manages relationships with multiple… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director, Clinical Outsourcing is from :157,200-206,300Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in… more
- Merck & Co. (Boston, MA)
- …Medicine (TMed) Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational...network of key cross-functional partners both within TMed, Discovery Research , and Global Clinical Development.-The candidate will… more
- Merck & Co. (Rahway, NJ)
- …& Respiratory Therapeutic Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic ... Job DescriptionThe Associate Vice President (AVP) will be responsible for...and tactical role in overseeing the scientific direction of clinical programs involving translational research and early… more
- Merck & Co. (Rahway, NJ)
- … clinical development across all therapeutic areas and all phases of clinical development at our company's Research laboratories. TMB laboratories leverage a ... flow cytometric assays that are deployed in support of clinical trials. The candidate for this Associate ...the transition of biomarker flow cytometry assays from Basic Research to Clinical Development.Design, develop, and optimize… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Insmed Incorporated (Bridgewater, NJ)
- …our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Merck & Co. (Rahway, NJ)
- … expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), ... clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.- Minimum education required: Ph.D. with 1-3 years of pharmaceutical drug… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Merck & Co. (Rahway, NJ)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are on time and within budget. The position may also collaborate with CROs ( Clinical Research Organizations) and manage oversight. The position will partner with ... of experience as statistician supporting drug development and/or post marketing in Clinical research , Pharmaceutical company, CRO or Medical Device setting… more
