- Canfield Scientific, Inc (Parsippany, NJ)
- …with the ability to multi-task and prioritize, and is driven to deliver high- quality , evidence-based insights that shape clinical research outcomes. The ideal ... Carry out literature reviews to support study design, outcome development, and clinical , commercial or regulatory activities Prepare, write, and review study… 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead the CRO and vendor ... study team in end-to end delivery of the clinical trial with consistency, quality and per...standards and timelines and that quality of data is suitable for regulatory submission. The… 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)
- …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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and understanding of CMC principles, strategies, and processes: Understand regulatory compliance/requirements of manufacturing clinical and commercialization ... involvement with all phases of project management Work with operations and quality groups to maintain products at a high level of performance/compliance Collaborate… 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)
- …- 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
- SOFIE (Totowa, NJ)
- …new products from concept to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212). If you're ... Responsibilities Develop protocols for the production and analysis of clinical -grade radiopharmaceuticals, validate these methodologies against quality … more
