- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP /Document Audits supports end-to-end audit activities per audit program of GxP ... document reviewMust have at least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials… more
- Damco Solutions (Princeton, NJ)
- …and experience in network infrastructure, security, data, and application development in GCP . *Proficient knowledge of Kubernetes along with practical experience in ... GCP Infrastructure services. *Experienced in migrating applications and data...level. *Mandatory skills and hands-on experience required in various GCP native services, including: Cloud Storage, Google Kubernetes Engine… more
- Technical Resources International, Inc (Bethesda, MD)
- Job Title Quality Assurance Manager-Good Clinical Practice ( GCP ) Location Bethesda, MD 20817 US (Primary) Category Quality Assurance Job Type Full-Time Salary Range ... regulatory authority inspection. Job Requirements Experience working in Quality Assurance GCP internal and client audits (minimum 5 years). Experience working with… more
- Cynet Systems (New York, NY)
- GCP DevOPs With Docker And Jenkins Pay Range: $70hr - $75hr GCP DevOPs with Docker and Jenkins, Terraform scripting for infrastructure and application deployment ... repository Git/GitHub, Nexus, Artifact Registry etc. Cloud service Google Cloud Platform ( GCP ), Compute Engine, GKE. Must have experience in design, build and… more
- Diverse Lynx (Louisville, KY)
- GCP Engineer having Azure, DevOps, Terraform, Kubernettes Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due ... consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse… more
- Insmed Incorporated (San Diego, CA)
- …and maintain a risk-based and scientific-based quality system to support GCP .Oversee regulatory agency inspections and vendor audits.Ability to ensure that a ... are conducted, and reports written according to SOPs and regulations.Oversee GCP activities (including internal or external audit observations and development of… more
- The University of Pennsylvania (Philadelphia, PA)
- …trials, ensuring compliance with institutional, FDA, and Good Clinical Practice ( GCP ) standards.The Department of Dermatology at the University of Pennsylvania makes ... to protocol and in accordance with Good Clinical Practice ( GCP ) (eg scheduling participant visits within the appropriate window,...all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and… more
- Cedent (Boston, MA)
- …framework while supporting sponsors and sites in meeting FDA, ICH, and GCP requirements. This role serves as the liaison between clinical operations, quality ... or sponsor. Certifications: RAC (Regulatory Affairs Certification) preferred. Current GCP training certification required. Regulatory Knowledge: Deep understanding of… more
- Diverse Lynx (Peoria, IL)
- The Program Manager will oversee the execution of projects related to GEN AI Testing and GCP Gen AI vision within a hybrid work model. With 8 to 10 years of ... results during day shifts. Top 3 Must Haves: 1. GCP Gen AI vision 2. GEN AI Testing 3....Testing 3. Project Management Experience: 8-10 yrs Required Skills: GCP Gen AI vision, GEN AI Testing, Commercial Gen… more
- Merck & Co. (North Wales, PA)
- …the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good planning, ... Communication, Data Analysis, Dermatology, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology,… more
- Merck & Co. (NJ)
- …operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesPreferredField-based medical experienceResearch ... Research, Clinical Studies, Clinical Trials, Communication, Good Clinical Practice ( GCP ), Immunoassays, Immunotherapy, Medical Affairs, Medical Teamwork, Parasitology, Pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage multi e competing priorities with good -planning , ... Critical Thinking, Data Analysis, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization,… more
- Merck & Co. (North Wales, PA)
- …Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good-planning, ... Cross-Functional Teamwork, Data Analysis, Drug Development, Ethical Standards, ICH GCP Guidelines, Identifying Risks, Life Science, Medical Writing, Motivation… more
- Merck & Co. (Chicago, IL)
- …field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities.Location: This is a remote ... Studies, Clinical Trials Operations, Dermatology, Gastroenterology, Good Clinical Practice ( GCP ), Inflammatory Bowel Diseases, Key Opinion Leaders, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …marketed products; required4 or More Years Knowledge of Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge ... databases; preferred4 or More Years Familiarity with Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP), PharmD, RN, or master's degree… more
- Boston Scientific (St. Paul, MN)
- …related regulations and guidelines (eg ISO, FDA medical device regs, GCP , etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership ... in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines or equivalent relevant experience Lead auditor certified in… more
- Eisai, Inc (Nutley, NJ)
- …Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and programs ... operations/ data management or related area. 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US,… more
- Eisai, Inc (Nutley, NJ)
- …the utmost compliance and quality consistent with Good Clinical Practice ( GCP ). This individual must effectively balance strategic vision with hands-on operational ... and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on… more
- Citigroup, Inc. (Irving, TX)
- …technologies in at least two public cloud environments including AWS. GCP and Azure. Responsibilities: Develop Cloud IAM strategies and security patterns ... record in the architecture, design and implementation of security solutions in AWS, GCP and Azure Demonstrated technical and team leadership skills Minimum of 7… more
- Alcanza Clinical Research (Roslindale, MA)
- …visits, documentation, and follow-up actions according to ICH/FDA guidelines, GCP , sponsor protocols, company SOPs, and policies. Key Responsibilities Under ... study protocol, company processes & procedures, and in compliance with FDA, GCP /GDP/ALCOAC, ICH regulations and guidelines: a. Screening of patients for study… more
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