- Lupin Pharmaceuticals (Coral Springs, FL)
- …applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP) development, ... projects, and clinical -regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design and execute clinical … more
- Merck & Co. (Rahway, NJ)
- …The VCM Product Leader will be responsible for supply chain design , global filing and launch strategy, long-range demand vs capacity planning, integrated risk ... product development lifecycle and integration of CMC and clinical strategy and ability to engage to ensure ...reliably launch with appropriate robustness and quality. Ability to design and optimize product supply chains to… more
- Merck & Co. (Rahway, NJ)
- …from any modality to support clinical development programs. The Chemical Modality Design Product is comprised of both in house created and commercially ... Sciences (RaDS) value team in R&D IT brings together product management, engineering, and data science expertise...the Product Manager of the Chemical Modality Design Product . This role is positioned with… more
- Merck & Co. (North Wales, PA)
- … development pre-launch planning to brand launch, and post-launch optimizationExperience leading product positioning, branding and using data to make informed ... HIV Business Unit consists of 3 inline products, a product currently under review by the FDA, and an...marketers.- Additionally, the CAT consists of experts in campaign design , development, and measurement. Your leadership will translate brand… more
- Formation Bio (New York, NY)
- … product teams. These predictive models will seamlessly integrate with our Clinical Development processes, directly impacting trial design and execution. This ... outcomes with validated examples Demonstrated success in partnering with engineering/ product teams to productize data science capabilities Exceptional… more
- Formation Bio (New York, NY)
- …harmonized data product creation. Lead integration of unstructured data sources ( clinical notes, publications, documents, scientific text) using NER, ... data into trusted, interoperable models that power analytics, product development, and scientific decision-making across the company.This is a high-impact… more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Eisai, Inc (Nutley, NJ)
- …population-based decision makers on health economic and product value data .Engage healthcare and access stakeholders in clinical , scientific, and health ... of survey design and use of psychometric tools to collect data and conduct clinical outcome assessments. Development of professional relationships with… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM ... Position Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (North Wales, PA)
- …a program leader.Must possess familiarity with statistical analysis methods and clinical data management concepts; strong project management skills;Excellent ... according to quality, compliance and timeliness requirements.Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (Rahway, NJ)
- …designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing ... core understanding of the drug development process - Demonstrated ability to independently design , execute and lead complex experiments and data analysis - Track… more
- Merck & Co. (Rahway, NJ)
- …designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing ... core understanding of the drug development process - Demonstrated ability to independently design , execute and lead complex experiments and data analysis - Track… more
- BioAgilytix (Durham, NC)
- …using chromatographic and mass spectrometric (LC/MS) techniques in support of preclinical, clinical , and product release studies. Design , plan, and execute ... sample analysis using advanced chromatographic and mass spectrometric techniques. You'll design and execute experiments, troubleshoot assays, analyze data , and… more
- Merck & Co. (Rahway, NJ)
- …development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. The y… more
- Merck & Co. (Rahway, NJ)
- … Clinical Judgment, Collaborative Communications, Communication, Cross-Functional Teamwork, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Good ... processes that deliver desired solid-state properties, purity, and yield for clinical programs across our diverse pipeline. This role involves the development… more
- Merck & Co. (Rahway, NJ)
- …of drug development processes in one or more of the following areas: clinical , regulatory, safety, medical, clinical data management, biostatistics.Excellent ... Customer Experience Design , Knowledge Management, Methods and Tools, Product Design , Researching, Stakeholder Relationship Management, Strategic Planning,… more
- Merck & Co. (North Wales, PA)
- …transformation goals. - Key Responsibilities Develop deep business acumen and expertise in data and data standards across Clinical Development, Medical ... and Information Architecture (BIA) group within our Research & Development Division's Clinical Development and Digital Solutions (CDDS) value team, - the Business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a risk-based quality management process fully embedded through trial design , execution and submission including all vendor managed activities with the ... goal of achieving the highest data quality standards, full adherence to patient's rights and...Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality… more
- Merck & Co. (Rahway, NJ)
- … clinical , economic, and patient-centered unmet needs and the value the product provides in addressing those needs. To design , execute and communicate ... To generate value evidence including value dossiers, evidence synthesis, clinical trial analyses, economic modeling and patient-reported outcomes. To support… more
- BioAgilytix (San Diego, CA)
- …them.The Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This ... team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies.Motivating team by inspiring employees… more
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