- 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
- Pfizer (New York, NY)
- …eg, Clinical Operations, Data Management, Safety, Biostatistics, Regulatory , Study Management, Pre- Clinical , Pharmacology, Quality Assurance. ... study results Support execution for all FIH programs through proof-of concept Set the clinical data review strategy, ensure quality data and conduct… more
- 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
- 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
- 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
- FleishmanHillard (New York, NY)
- …to meet deadlines and manage multiple projects simultaneously. + Ability to communicate clinical data and information into lay language that resonates across ... media, third-party organizations, healthcare professionals and consumers. Influencer campaigns, data milestones, product launches, medical congresses, patient storytelling, awareness… 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
- 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)
- …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
- 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
- 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)
- …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
- 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
