- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Senior Director has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines.… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've... and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical … more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...discipline (advanced degree preferred) with minimum 12 years in clinical research / operations/ data management or related… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... Material(s):NoRequired Skills:Adaptability, Adaptability, Clinical Data, Clinical Operations, Clinical Outcomes, Clinical Research , Clinical … more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research , ... Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's Research & Development… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) ... Adaptability, Biological Sciences, Clinical Data, Clinical Data Interpretation, Clinical Operations, Clinical Research , Clinical Study Design,… more
- Merck & Co. (Rahway, NJ)
- …managing the 'end-to-end' integrated clinical supply chain across the full c ompany's Research & Development Division portfolio of clinical trial s .- GCS is ... for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address … more
- Merck & Co. (Rahway, NJ)
- … Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Research & Development Division ... Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and… more
- Eisai, Inc (Nutley, NJ)
- …the clinical operations function in the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good ... clinical operations activities. These activities directly impact the timeliness, quality , and successful execution of clinical studies in accordance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Oversees typically… 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 ...reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …develop strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders across the organizations ( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and ... solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development ... global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality … 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)
- Job Description Responsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early ... programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into… more
- Novo Nordisk Inc. (Orlando, FL)
- …The EDCS must achieve sales goals by utilizing a patient-centric and clinical approach to engaging their customers and promoting Novo Nordisks portfolio of ... assess, create and maintain advocacy of customers aligned to company, brand and clinical goals; the EDCS develops local strategies and executes local tactical plans… more
- Merck & Co. (Rahway, NJ)
- … Clinical , Regulatory, Statistical Programming, Data Management and other company Research Laboratories Scientists in designing and analyzing clinical trials, ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...and in coordinating the statistical activities for clinical drug/vaccine projects.The incumbent may initially work in a… more
- Merck & Co. (Rahway, NJ)
- …primarily for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group ... Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling… more
- Merck & Co. (Rahway, NJ)
- …regulatory requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... supporting regulatory filings.Collaborate with key stakeholders across the organizations ( Research Division / Manufacturing Division) to drive key capability… more
