- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting , publication, and presentation at national and ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication.Specifically, the Director may be ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting , … more
- Merck & Co. (Rahway, NJ)
- …:This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Merck & Co. (Upper Gwynedd, PA)
- …CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development. Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… 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 ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.… more
- Merck & Co. (Rahway, NJ)
- …dynamic late stage biologics pipeline within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Cell Culture Commercialization Leader, you ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance ... with Global PV regulations for individual case safety and periodic reporting . Contribute as a key DSI contact for PV service providers to address, escalate issues… 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. (Bernards, NJ)
- …audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews ... initiatives for development activities / programs post internal system audit.Support reporting of quality metrics for audits and inspections and execute against… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 data. Maintain a comprehensive understanding of global… 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 ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Twist BioScience (South San Francisco, CA)
- …of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation: Oversee the full Software… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Tris Pharma (Monmouth Junction, NJ)
- …liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), ... reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate… more
