- Eisai, Inc (Nutley, NJ)
- …audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and ... an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research / operations/ data management or related area. 5+… more
- Merck & Co. (San Francisco, CA)
- …one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for ... partner with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS)… more
- Aequor (Athens, GA)
- …Animals, Guide for the Care and Use of Agricultural Animals in Research and Teaching, BI AH policies and Veterinary Sciences standard operating procedures, ... sanitation and facility maintenance. This individual will work in an animal research laboratory setting under Biosafety Level 1 and 2 conditions. This person… more
- Merck & Co. (Rahway, NJ)
- …needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally.Types of studies executed include prospective and retrospective ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… more
- Merck & Co. (North Wales, PA)
- …Material(s):n/aRequired Skills:Biostatistics, Clinical Development, Communication, Data Management , Epidemiology, Health Economics, Health Outcomes Research , ... Management Process, Marketing Strategies, Medical Affairs, Neuroanatomy, Outcomes Research , Pathophysiology, Pharmacokinetics, Researching, Social Collaboration, Stakeholder Relationship … more
- Merck & Co. (North Wales, PA)
- …ApplicableShift:Valid Driving License:Hazardous Material(s):Required Skills:Business, Data Management , Epidemiology, Health Economics, Health Outcomes ... the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based...Research , Health Sciences Research , Management Process, Medical Economics, Medical Teaching,… more
- Eisai, Inc (Nutley, NJ)
- … research strategies, designing and providing oversight of clinical programs.Demonstrated experience in stakeholder management , vendor management ... PhD's, reporting to this role. Responsibilities: Provide leadership and successfully manage clinical research programs, and key business objectives within the… more
- Eisai, Inc (Nutley, NJ)
- …the programming team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards, eg, InForm, ... Oracle, SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.Strong… more
- Eisai, Inc (Nutley, NJ)
- … clinical development programs across different phases.The VP of Global Clinical Operations is responsible for the management , oversight, and direction ... This individual must effectively balance strategic vision with hands-on operational management strategies to expedite clinical operations activities. These… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of ...OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRTAssist with tracking SAE safety… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... 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
- Merck & Co. (Rahway, NJ)
- …will: Execute solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data ... Position Overview - Basic Functions & Responsibility The Global Clinical Supply (GCS) organization is within our Research...Business Process Management (BPM), Business Support, CAPA Management , Clinical Supply Chain Management ,… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems , Quality Risk Management , Technical Writing, Test and ... review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of… more
- Merck & Co. (North Wales, PA)
- …with scientific leaders, patient organizations, academic medical centers, health systems , research organizations, database holders, and others.To prepare ... outcomes research protocols, statistical analysis plans, and clinical study reports.To ensure findings are communicated effectively at scientific conferences, in… more
- Merck & Co. (Rahway, NJ)
- …Facilitate equipment/ system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & global ... (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). Troubleshooting ability (mechanical/electrical/automation) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Merck & Co. (Chicago, IL)
- …Clinical Medicine, Cross-Functional Teamwork, Dermatology, External Engagement, Good Clinical Practice (GCP), Healthcare Delivery Systems , Healthcare ... products. The work of an RMSD is aligned to: Scientific Exchange, Research , Scientific Congress Support, and Scientific Insights.RMSDs liaise between the scientific… more
- Merck & Co. (North Wales, PA)
- …Algorithms, Applied Mathematics, Biostatistics, Business Process Improvements, Business Strategies, Clinical Development, Clinical Research , Clinical ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and ... high-quality products, test methods, and robust manufacturing processes for both clinical and commercial use. This position interacts extensively with subject-matter… more
- Eisai, Inc (Louisville, KY)
- …required and assigned by the management .Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs.Develop, implement ... and present to management plans to support Medical Affairs strategic direction for...drug launch experience is strongly preferred.Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG… more
