- Insmed Incorporated (NJ)
- …of scientific information.Experience presenting drug safety topics, clinical and safety data to regulatory authorities, health authorities, or at ... responsible for appropriate review of all safety data from various sources (eg pre- clinical , ...global PV regulations and applicable ICH guidelines.Experience in preparing clinical safety assessments and regulatory … more
- Eisai, Inc (Miami, FL)
- …Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. ... will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety , will lead the development and implementation of integrated ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in order to accomplish objectives. Relationship Reports to the Director, Patient Safety Data Acquisition & Support. Interacts with colleagues within Patient ... About the Department The Clinical , Medical and Regulatory (CMR) department...Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety , Regulatory , Quality, Legal, Privacy and Finance.… more
- Bayer (Whippany, NJ)
- …and maintenance of product licenses (eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the ... to interpret, discuss, and present clinical trial or section program-level data ;Proven experience with FDA regulatory requirements and ICH GCP guidelines for… more
- Merck & Co. (Boston, MA)
- … and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new ... clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,... Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Data… more
- Eisai, Inc (Nutley, NJ)
- …study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy.Contributes to Clinical ... of the study from protocol concept to final report including interpretation of clinical data .Serves as Medical Monitor (where applicable) to review and monitor… more
- Formation Bio (New York, NY)
- …as a project physician.Your ability to understand and navigate the complexities of healthcare data and clinical trials will be essential to your success and the ... and clinical development plans Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy… more
- LabCorp (Raritan, NJ)
- …science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements Previous clinical laboratory testing experience ... Are you an experienced Clinical Lab Professional? Are you looking to embark...applicable degrees/certifications, as well as internal equity and market data Work Schedule: Monday - Friday 8:00 am -… more
- LabCorp (Shelton, CT)
- …science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements Previous clinical laboratory testing experience ... Are you an experienced Clinical Lab Professional? Are you looking to embark...and discard chemical reagents such as reagent alcohols Perform safety checks in lab Work with chemicals such as… more
- Merck & Co. (South San Francisco, CA)
- … clinical trials (Phase I), ensuring robust study design and high-quality PET data collection. Regulatory support : Familiarity with regulatory and ... safety /compliance). Prepare and contribute PET-specific scientific content for regulatory filings, including IND submissions. Partner and site management :… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in ... scientific and strategic input to project teams across discovery, preclinical, regulatory , and clinical functions.Manage non-GLP and GLP-compliant studies… 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. (North Wales, PA)
- …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. (North Wales, PA)
- …complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic ... for analysis and programming requests in close collaboration with statistical and clinical colleagues, retrieve the required data , and then transform the… more
- Merck & Co. (North Wales, PA)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure ... agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The...with the CRO, feasibility team and the study team.Assist Data Management with development of the clinical … more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... : This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary… more
- Merck & Co. (Rahway, NJ)
- …including complex data preprocessing, filtering, and manipulationProgramming expertise with clinical endpoint data (efficacy and safety ) and ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … more
- Bayer (Urbandale, IA)
- …DSO principles; Healthcare sales experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging ... 3 or more years of experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging suites (eg,… more
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