- Eisai, Inc (Nutley, NJ)
- … Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but ... user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of … more
- Merck & Co. (North Wales, PA)
- … scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
- Merck & Co. (Rahway, NJ)
- …scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in ... in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality, completeness , and integrity… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Nutley, NJ)
- …an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years ... US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical… more
- Merck & Co. (Rahway, NJ)
- …company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials to ensure ... Perform quality assurance activities related to API manufacturing in a complex, clinical supply development.- Review and/or approve GMP documents. Ensure all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … or medical lead and biostats to ensure availability of necessary data - Coordinate author review /approval internal review approval- Abstract/manuscript ... in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author… more
- Novo Nordisk Inc. (Orlando, FL)
- …techniques Maintain up to date knowledge of the latest approved scientific and clinical data to engage in meaningful discussions with customers and address ... experience using sales data /call reporting software ideal Mastery knowledge of the clinical management of diabetes and the range of treatment options Must be a… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data … more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …required activity records/reports, including timely and accurate transmission of call data Understand the scientific and clinical underpinnings of brand ... Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts,… more
- Merck & Co. (North Wales, PA)
- …Clinical Study Design, Clinical Testing, Clinical Trial Management Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data ... knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and… more
- Genmab (NJ)
- …regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical data that enhance the value and appropriate ... through scientific exchange in a fair and balanced manner and provide clinical /scientific support for Genmab's pipeline.Domestic travel of approximately 50% will be… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Novo Nordisk Inc. (Dayton, OH)
- …assess, create and maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes local tactical plans ... partners. The OCS also assists their customers with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, materials,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing ... strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Merck & Co. (Rahway, NJ)
- …concepts, tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Eisai, Inc (Louisville, KY)
- …knowledge and participate in scientific exchanges and interactions with identified KOLs.Present clinical , scientific and economic data on Eisai's products and ... and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data .Demonstrate full knowledge of and… more
- Taiho Oncology (FL)
- …trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and ... and participate in scientific exchanges and interactions with identified KOLs Present clinical and scientific data on Taiho's products and relevant therapeutic… more
- Merck & Co. (Rahway, NJ)
- …the countries, that guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I staff globally in ... Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid… more
