- Merck & Co. (North Wales, PA)
- …(GCTO) and Business Development (BD) to assess the operational and regulatory capabilities of DHTs and SaMDs, identify regulatory risks and requirements. ... within the metrics process Hands-on experience in the conduct and execution of regulatory digital health assessments Development of critical analysis and project… more
- Merck & Co. (Rahway, NJ)
- …and different perspectives. Additionally, you will have access to a career development advisor who will offer support and guidance in managing your career. - As ... intellectually curious, join us-and start making your impact today.-Overview: The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory … more
- Merck & Co. (North Wales, PA)
- … requirements, internal standard operating procedures, and external regulatory requirementsEvaluates appropriateness of available software for planned analyses ... analysis , and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.May represent biostatistics in regulatory interactions… more
- Merck & Co. (Rahway, NJ)
- … analysis to provide meaningful insights for teams developing business cases and making investment decisionsAbility to guide and influence interdisciplinary ... Division IT spanning the LROP including Discovery, Clinical and Regulatory .This role also supports the SVP of the Chief...ability to act as strategic thought partner and trusted advisor to the businessSkilled in data analysis … 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 ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Merck & Co. (Rahway, NJ)
- …and unplanned statistical analysesPrepare compliant programming code for regulatory submissions including analysis /modeling datasets, tables, listings, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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 ... projects. -Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… 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 ... Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Merck & Co. (North Wales, PA)
- Job DescriptionResponsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and ... user requirements, retrieve the required data, transform the data into modeling-ready analysis datasets, and develop tables and figures according to the modeling … more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental safety, integration of new/existing ... in the development of predictive and preventive maintenance programsExecutes functional business plans and contributes to the development of group or company… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… more
- Merck & Co. (North Wales, PA)
- …oversight and creation of the Study Data Tabulation Mode (SDTM) deliverables for analysis and reporting and world-wide regulatory application submissions of drug ... with internal and external stakeholders including Statistical Programming, Statistics, Regulatory , Data Management, Clinical and other project stakeholders.- Primary… 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 ... skillsSuperior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for Research & Development projects (data,… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Merck & Co. (Rahway, NJ)
- …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory … more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX), experience in microbiological… more
- Merck & Co. (Rahway, NJ)
- …strategies in clinical trials.Reviewing/writing memos, final reports, related regulatory documentation and publications summarizing data, and reviewing/editing lab ... project teams, biomarker leaders, companion diagnostics leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical… more
- Merck & Co. (Durham, NC)
- …supervision and/or project/automation/IT support.Proven record of proficiencies associated with business analysis on small sized projects.-Strong hands-on MES ... goals.Provides training sessions to our Company personnel pertaining to MES requirements. BUSINESS EXPERTISE:Understands the fundamental business drivers for the… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta- analysis (MBMA) and clinical trial simulations (CTS) into programs… more
