- Merck & Co. (Rahway, NJ)
- …pipelines) and relevant systems (LIMS, MES, SAP). Experience in data governance, data stewardship, and data quality management in regulated environments. ... sections, enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation.- - - Under the… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Good Clinical Practice (GCP), Nursing, Patient Education, Quality Management, Quality Standards, Regulatory Compliance, Regulatory ... in any GCTO footprint country Required Skills: Adaptability, Adaptability, Business Processes, Clinical Data Management, Clinical Research, Clinical … more
- Merck & Co. (Rahway, NJ)
- …Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting ... the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed… more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines… more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential... Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Data… more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (Rahway, NJ)
- …project level Position Specific Required Skills and Experience: Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic ... in CDISC SDTM and ADaM standardsSignificant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPHDesigns… more
- Merck & Co. (Rahway, NJ)
- …be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (Rahway, NJ)
- …cross-function teams to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable ... products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will… more
- Merck & Co. (Rahway, NJ)
- …and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... appropriate identification, evaluation, and management of risks associated with product quality . Build strong relationships with regulatory agencies and other… more
- Merck & Co. (Rahway, NJ)
- …technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory , Quality , and Supply Chain from early development through to ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Supplies and Development Batches to meet Clinical Development Program requirements.-Partners with Quality , Operations, Technology, and ... others.-Knowledgeable of cGMP's, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory issues.-… more
- Merck & Co. (Rahway, NJ)
- …stakeholders to deliver high value product solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and ... with the product vision. Work effectively in regulated environments; partner with clinical , compliance and quality teams when delivering regulated features (GxP,… more
- Merck & Co. (Rahway, NJ)
- …, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Support ... improvement mindsetPRDRequired Skills: Accountability, Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, Deviation… more
- Merck & Co. (Rahway, NJ)
- …models in Enterprise Architecture repository. Implement governance standards for data quality , data lineage, security, and regulatory adherence. Conduct ... data integration, governance, and accessibility across the complex clinical development ecosystem. Reporting to the BIA team lead,... data and data standards across Clinical Development, Medical Affairs, and Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Merck & Co. (Rahway, NJ)
- …- Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... of release, characterization, and stability assays for testing of clinical trial material and in support of product and...- Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) and… more
- Merck & Co. (Rahway, NJ)
- …adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The Director will collaborate closely with the US patient ... with operational excellence.Strong analytical mindset with proven experience using data to drive decision-making.Excellent communication and presentation skills. -… 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 ... Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality , Legal, Privacy and Finance. External relationships… more
