- Merck & Co. (North Wales, PA)
- … clinical data /medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... patient HUB patient support programs Develop performance dashboards and interpret hub data for purposes of assessing market access trends, hub program utilization,… more
- Merck & Co. (North Wales, PA)
- …and systems, and for implementing quality control measures to ensure data accuracy and integrity.-Collaborate with other departments: Collaborate with departments ... such as clinical , regulatory, and safety to ensure that PV processes...quality standards.- Preferred Capabilities: Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and systemsPrior… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Marketing Women's Cancers Associate Director is a vital role that will be responsible for shaping Women's Cancers indications across ... teams including Market Access, Medical, Market Research, Human Health Digital Data & Analytics (HHDDA), Human Health International (HHI), Key Regional/Market teams,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director will report directly to the US Marketing Leader for New Products and play a critical role in the US commercial development ... The role will work across the enterprise to define value evidence and clinical development needs to support US commercial forecasts. As our new products progress… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to realize your potential? The Position To support the Director of US Tax Operations in leading and managing tax operations, tax compliance, ... with key stakeholders and developing self, team and organization. Relationships Reports to Director of US Tax Operations. Member of NNI Finance & Operations -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .-...with data manager to ensure high quality data .- Drug Development Strategy: Provides input to multiple aspects… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist which is an Executive Director level reporting to an Associate Vice President in Development Sciences & Clinical Supply . The ... scientific direction and partner with the Development Sciences and Clinical Supply Digital Leadership Team to define the in...problem-solving, with a particular focus in the areas of data science and analytics. Experience in one or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technology transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process, and support ... data transfer to the appropriate data repository - liaison between the Tech Strategy (...manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analytical tools. Analytical Resource Management will focus on implementing a data driven approach to optimizing resource deployment, productivity and costs through ... the development of advanced algorithms using machine learning based on historical data and LF input- Enable talent skill mapping, leveraging skills of associates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug...with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... and communication of HEOR evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR team members and others… more
