- Merck & Co. (Rahway, NJ)
- …Area Lead The Associate Director, Global Clinical Data Standards Therapeutic Area (GCDS TA)- Lead is a subject matter expert in the area of data ... initiatives.-The Global Clinical Data Standards Therapeutic Area (GCDS TA) Lead is responsible for:Defining standard collection and mapping data definitions,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support MCT activities. The Director serves as primary functional partner and MCT subject matter expert for the MCT integrated technology ecosystem and partners ... with the Digital Strategy Innovation team- Act as a subject matter expert in MCT function and...support to internal and external customers and contributing to training and knowledge sharing activities- Lead the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and payments and compliance with US and Global reporting requirements. As GCO's Subject Matter Expert (SME) for the site budget, payment, reporting and ... clinical trial spend. Financial Transparency (FT) and MMSEA Reporting Compliance Provide subject matter expertise in the implementation of transparency and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulatory requirements. Participates in audits as an external data management subject matter expert and provides guidance and/or training to study teams in ... and protocol defined analysis endpoints (primary, secondary, etc.) thereby serving as a subject matter expert for all external data management business needs.… more
- Merck & Co. (Durham, NC)
- …ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert during tours to provide area/process overview information to ... at the shop floor level within the team and site.Provide mentorship and training to team and peers.Liaison effectively with alternate shifts, site Maintenance &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the medical team ... the field team, and assists the Program Development and Training function for the TA. SD will engage in...areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts.-Support the build of industry expertise ... such as Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc.-Work with and/or support subject matter experts to determine needs and build business cases… more
- Bering Straits Native Corporation (Arlington, VA)
- …their knowledge area and applies their expertise to the project.Provides expert-level subject matter expertise in program planning, design, technical assistance, ... study, as well as functional and technical expertise to lead simple to complex projects to deliver client solutions...be used in lieu of education.Has broad and deep subject matter knowledge.Expert ability to work effectively… more
- Aequor (Newbury Park, CA)
- …initiatives. Work with stakeholders to gather requirements and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory ... this job, the type of degree would not necessarily matter . Top 3 qualities of the hiring manager's ideal...to communicate clearly with internal and external teams. Once training is completed, this individual must then understand how… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a Therapeutic Area ... generation plans based on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings… more
- Merck & Co. (Rahway, NJ)
- …on fit-for-purpose assay validation.Troubleshoot assay and instrument-related issues.Serve as a subject matter expert in flow cytometry by collaborating with ... assays that support our pipeline.The individual will have the following responsibilities: Lead in the transition of biomarker flow cytometry assays from Basic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts. Support the build of industry expertise ... WCG/Avoca, SCOPE, SCRS, DIA, etc. Work with and/or support subject matter experts to determine needs and...mapping), and/or Power Point presentations, as needed. Facilitate and/or lead change management activities- GCO Training : Support… more
- Merck & Co. (Rahway, NJ)
- …Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and ... of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides biostatistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional teams. Able to understand, communicate with, and influence senior-level subject matter experts and key stakeholders. Qualifications: Successful ... accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to any therapeutic… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and process risk assessments in conjunction with Quality and Manufacturing subject matter expertsOversee development and execution of validation protocols ... Position Summary:Oversee and lead the validation program for production equipment and...during production or validationWork with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA… more
- Merck & Co. (Durham, NC)
- …responsibilities include, but are not limited to, the following:Serve as site subject matter expert in rollout and implementation of Durham's new ... of Practice and network with other sites for OnePMO best practices.Provide training on OnePMO as needed to site personnel.Support, maintenance, and governance of… more
- Eisai, Inc (Nutley, NJ)
- …and budget impact analyses of health technologies.Serve as the subject matter expert and independent project lead responsible for overseeing all aspects ... work as well as manage performance and ensure adequate training and support of staff. Some travel may be...of project initiation, implementation, and delivery. Lead and manage the execution of advanced modelling and/or… more
- Insmed Incorporated (Bridgewater, NJ)
- …representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical ... years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key stakeholders (Legal, Compliance, Quality Assurance (QA) and Medical Affairs Subject Matter Experts) across functions, geographies and levels of the ... program, publication, medical education, Advisory boards) preferred- Ability to integrate subject matter expertise and cross-functional perspectives to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … performance leading to sustained right first-time execution. Serve as subject matter expert for Compliance & Training systems. Knowledge of LMS system. ... New Jersey. Role Overview Technical Trainer will be responsible for performing training activities for Operations team members who support cGMP Clinical and… more
