- Genmab (NJ)
- …and clinical trial 'face' with our sites.Additionally, the Manager may also support on-site and/or remote trial oversight activities (within a region upon ... improvement.Supports and contributes to operational site engagement tactics to accelerate trial execution, support patient engagement and diversity that… more
- Merck & Co. (Rahway, NJ)
- …and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process developmentA ... strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program… more
- Merck & Co. (Rahway, NJ)
- …and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development - ... A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program… more
- Genmab (NJ)
- …indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director ... in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication… more
- Genmab (NJ)
- …compound lead, primarily up until proof of concept, and/or as trial responsible statistician.ResponsibilitiesCompound/Indication LevelAct as lead and main point of ... in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication… more
- Merck & Co. (Rahway, NJ)
- …implementing novel quantitative approaches (for eg, comparator modeling, clinical trial simulations,- quantitative system pharmacology (QSP) and disease progression ... appropriate quality systems and IT infrastructure for QP2 to support emerging capabilitiesResponsible for priority-setting, performance management, hiring and… more
- Merck & Co. (Rahway, NJ)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes...plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes...plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life… more
- Aequor (Thousand Oaks, CA)
- …competency-based onboarding, upskilling, and transformation support for staff. Support departments across R&D, including: Clinical Trial Execution ... cross functional collaborations between clinical operations, data management, clinical trial management systems, biostatistics, regulatory and safety a plus.… more
- Merck & Co. (Rahway, NJ)
- …a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be sufficient ... methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical,… more
- Eisai, Inc (San Diego, CA)
- …and participation in strategic thinking. Essential Functions Product/Therapeutic Area Support to External Stakeholders Act as the primary clinical/scientific ... products and relevant therapeutic areas to population-based decision-makers, as requested. Support assigned professional congresses in accordance with MSL plan. Be… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .-Design and maintain statistical databases that support multiple ... closely related field plus 9 years SAS programming experience in a clinical trial environmentOR a Master's degree (or US equivalent) in Computer Science, Statistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and patent applications in the US and globally, and provide legal support for licensing, co-promotion, co-development, clinical trial collaboration, co-marketing ... for strategic settlements of such IP related matters.- Provides legal support , as needed in negotiating, drafting and reviewing licensing, co-promotion,… more
- Genmab (NJ)
- …Then we would love to have you join us!The RoleProvide hands-on programming support for production and QC/acceptance testing of ADaM and TLFAssist with the creation ... of trial level/pooled ADaM specificationsServe as backup for ...Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional… more
- Merck & Co. (Rahway, NJ)
- …delivery, & maintenance of a portfolio of metrics/analytics tools to support strategic decisions, improve planning/execution, and monitor performance across our ... portfolio, studies & processes within Global Clinical Trial Operations (GCTO). - Primary responsibilities include but are not limited to: Supports team members with… more
- Insmed Incorporated (New York, NY)
- …with external healthcare practitioners to provide comprehensive medical and scientific support for the therapeutic area of Chronic Rhinosinusitis without Nasal ... and scientific information on Insmed therapeutic disease areas and/or product support of appropriate prescribing, improved patient outcomes.Present data on Insmed… more
- Eisai, Inc (Cincinnati, OH)
- …working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Works closely with ... of the MSL team, including corporate aligned objective/tactics, cross-functional medical support , and interactions with key opinion leaders. Provide leadership for… more
- Merck & Co. (Rahway, NJ)
- …marketed Atherosclerosis drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug ... development of new compounds, and the further study of marketed compounds. Support of business development assessments of external opportunitiesThe Senior Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliance and working toward building a quality mindset with Medical Affairs. Support the Sr. Director's Medical Affairs Quality strategy by partnering with ... implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed activities with… more
- Merck & Co. (North Wales, PA)
- …medical advisors, payers, and scientific leaders-to ensure strategic alignment and support local data generation, congress planning, and advisory boards Serves as ... while also serving as a review panel member on TA specific MISP's to support the EDSA review process. Manages programs (patient support , educational or risk… more
