- Merck & Co. (North Wales, PA)
- …sciences, information science, pharmacy, or related scientific discipline plus literature-related regulatory reporting Bachelor's and 5+ years Master's/PhD and ... Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting , editorial, and… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication.Specifically, The Senior Director May ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication.-Specifically, the Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication.Evaluating pre-clinical and translational ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …local and global project teams. This role will be a senior member of the Regulatory , Quality and Clinical Reporting (RQC) team, and will provide mentorship and ... project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the written deliverables… more
- Merck & Co. (North Wales, PA)
- …curious, join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across the ... support OPS (Operations, Processes, and Strategic Execution) Policy Execution and the regulatory strategy of digital health tools (DHTs) and software medical devices… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the latest technologies and tools available Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Merck & Co. (North Wales, PA)
- …creation of the Study Data Tabulation Mode (SDTM) deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine ... with internal and external stakeholders including Statistical Programming, Statistics, Regulatory , Data Management, Clinical and other project stakeholders.- Primary… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... on activities related to study design, protocol development, study execution, reporting and interpretation of dataMaintain a comprehensive understanding of global … more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and ... processes. Working knowledge of early and late-stage submissions per local/ regulatory requirements, demonstrated ability to self-start, be solution-oriented with an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... to the design of studies, writing of protocols and other study and regulatory -related documents for DCR-PHXC, and other programs Participate in the analysis and… more
- Merck & Co. (North Wales, PA)
- …:This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning ... tables, listings and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Statistics stakeholders. -The Associate… more
- Merck & Co. (Rahway, NJ)
- …that our environment and our neighbors are not impacted.This role, reporting to the Executive Director of Environmental Compliance, Sustainability & Stewardship ... functions of our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a team of… more
- Toyota Boshoku (Hopkinsville, KY)
- …reporting , new hire reporting , and other state or federal regulatory reporting requirements. E. Support team member communication, involvement, and ... the maintenance and management of specialized human resource information and measurement/ reporting systems. 1. Perform specialized technical tasks, such as benchmark… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across the pipeline portfolio, the Lead ... Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs, analytics, and other relevant NNI departments to define… more
- Merck & Co. (North Wales, PA)
- …with internal and external stakeholders including Statistics, Clinical Research, Regulatory , Observational Research, Clinical Safety and PK/PD Modeling and ... and significant experience in setting strategy and developing analysis and reporting deliverables for Research & Development projects (data, analyses, tables,… more
