- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all ... conducted efficiently, within budget, and in compliance with regulatory standards . The Head of Clinical Operations leads...clinical development programs across different phases.The VP of Global Clinical Operations is responsible for the… more
- Merck & Co. (North Wales, PA)
- … Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Dermatology, Drug Development, Ethical Standards , ICH GCP Guidelines, ... trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical… more
- Merck & Co. (Rahway, NJ)
- … Trial Management, Clinical Trials Analysis, Communication, Critical Thinking, Data Analysis, Drug Development, Ethical Standards , ICH GCP Guidelines, Life ... trial team. Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in collaborations with the Clinical … more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Eisai, Inc (Nutley, NJ)
- …to prepare medical affairs personnel to enter strategic and compliant discussions regarding medical/ clinical data on Eisai products. The AD assumes a leadership ... insight collection and exchange by establishing training and mentoring standards and a global MSL insight forum....including treatment landscape training (disease state and Eisai product data , pre- clinical data , experiential training,… 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 ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx ... between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data , demographic/representativeness of samples from clinical trial and… more
- Eisai, Inc (Nutley, NJ)
- …and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation ... an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years… more
- Merck & Co. (Rahway, NJ)
- …and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and ... vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (Rahway, NJ)
- …results-oriented project management skills Preferred Experience and Skills: At least 5 years global or US medical affairs or clinical development experience with ... Job DescriptionThe Executive Director Pulmonary Hypertension, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) (referred to as EDMA) is… more
- Novo Nordisk Inc. (Hackensack, NJ)
- …techniques Maintain up to date knowledge of the latest approved scientific and clinical data to engage in meaningful discussions with customers and address ... offer the chance to be part of a truly global workplace, where passion and engagement are met with...data /call reporting software ideal Mastery knowledge of the clinical management of diabetes and the range of treatment… more
- Merck & Co. (North Wales, PA)
- …Dossiers for use by local subsidiaries in their local HTA submissionsDevelops supplementary clinical data package in close partnership with markets and HTA ... Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Biomaterials Science, Biostatistics, Clinical Development, Data Management, Epidemiology, Health Economics,… more
- Merck & Co. (North Wales, PA)
- … Clinical Trial Management, Communication, Communication Management, Cross-Functional Teamwork, Data Analysis, Drug Development, Ethical Standards , ICH GCP ... Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Clinical Data , Clinical Operations, … more
- Merck & Co. (Rahway, NJ)
- …work.-Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in ... 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)
- …work.Develops American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers.Develops supplementary clinical data package in ... 10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Biostatistics, Clinical Development, Communication, Data Management, Epidemiology, Health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the compound.- Responsible for scientific communications and publications; interpretation of clinical data ; ensuring consistency of clinical content and ... required- 4 or More Years experience in pharma at local, regional and/or Global level. preferred- Excellent knowledge of current clinical practice in Oncology… more
- Merck & Co. (Rahway, NJ)
- …experience in CDISC SDTM and ADaM standards .Must possess programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data ... data , derived PK parameters).Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.Ability… more
- Genmab (NJ)
- …the development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data ... at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker… more
- Merck & Co. (North Wales, PA)
- …to be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM ... Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good… more
