- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulatory requirements, and emerging technology innovations to optimize Daiichi Sankyo's clinical data standard processes. Qualifications: Successful ... employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member of ... finalization of materials, and distribution to executive leadership.Manages vendor(s) for clinical trial data visualization dashboards to ensure accuracy of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and ... and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational ... oversight standard practices across GCO and work with Global Clinical Operations, as needed, to understand business priorities.Develop and establish more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and ... data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Eisai, Inc (Nutley, NJ)
- …and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.Strong communication and organizational skills.Demonstrate effective ... responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applications and best practices as well as strong technical skills in working with ( clinical ) data . The position holder will require strong skills in continuous ... data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure timely and accurate completion of AI/ML… more
- Merck & Co. (North Wales, PA)
- …policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, ... to 50% travel required with some overnight.Role Summary The Regional Medical Scientific Director - GI Oncology is a credentialed (ie, PhD, PharmD, DNP, MD)… more
- Insmed Incorporated (Bridgewater, NJ)
- …input into publication planning and review, medical backgrounders, FAQ and standard responses, internal training approach and data disseminationPropose future ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Medical Director is a key leadership role and will develop, implement, and lead… more
- Merck & Co. (Rahway, NJ)
- …The Equipment Development and Facility Engineering (EDFE) Leader position will report to the Director , Engineering and will be a member of the EF Team at the Rahway ... the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team member supporting… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead the gene therapy ... milestones in launch planningMedical leadership input for cross functional partners including clinical , operations, HEOR and commercial to ensure that there is a… more
- Insmed Incorporated (Jacksonville, FL)
- …and/or product support of appropriate prescribing, improved patient outcomes. Present data on Insmed products to HCPs including physicians, academic institutions, ... knowledge and competency of Insmed therapeutic disease states, products, and competitor data . Serve as a local medical and scientific resource to Insmed for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… 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...practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC...communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with… more
- Merck & Co. (Rahway, NJ)
- …at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the ... Senior Director , GMA Oncology (Global Medical Affairs team lead for...medical information, internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, ... - Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain ... programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced… more
