- Organon & Co. (Jersey City, NJ)
- …Director will work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, ... the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical...regulatory standards. + Ability to understand and interpret clinical and scientific information and data and… more
- Organon & Co. (Jersey City, NJ)
- …field. + Five years of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs, ... program information in reports and systems to enable high quality portfolio communications. + Contribute to and facilitate an...and leadership. + Seek internal and external information and data points to inform best practices and options. +… 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)
- …preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable ... 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound...Accountability, Adaptability, Clinical Data Management, Clinical Development, Clinical Quality Management,… 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)
- …strategy for clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas ... Clinical Supply Chain Management, Clinical Trial Management, Clinical Trials, Cross-Functional Team Leadership, Data Analysis, Demand Planning,… more
- Merck & Co. (Rahway, NJ)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical… 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)
- …and early-phase clinical trials (Phase I), ensuring robust study design and high- quality PET data collection. Regulatory support : Familiarity with ... regulatory and quality frameworks applicable to radiopharmaceuticals (GMP for radiopharmaceuticals, IND/CTA...expert on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, … more
- Merck & Co. (Rahway, NJ)
- …patterns and disease progression, answer clinical development questions, and support regulatory submissions using Real World Data . In this role, the senior ... the benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting and regulatory submission… more
- Merck & Co. (Rahway, NJ)
- …for analysis and programming requests in close collaboration with statistical and clinical colleagues, retrieve the required data , and then transform the ... Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (Rahway, NJ)
- …and responsibility Preferred Skills: Knowledge of pharmaceutical development processes and clinical endpoint data (efficacy and safety)Good working knowledge of ... and geographies.#EligibleforERP- BARDS2020- SPJOBS VETJOBS Required Skills: Base SAS, Clinical Testing, Collaborative Development, Communication, Computer Science, 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)
- …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)
- …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)
- …O3Job Family: Manuf/OperationsSenior Technician, OperationsPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development and … 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)
- …oversee device risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires extensive ... implementation of risk control measures.Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of ... functions, activities, and operations of assigned departments to provide high quality , efficient, and cost-effective patient care and ensure compliance with… more
