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Experience reviewing regulatory documents, DMPK and BA reports , and non-GLP/GLP data and notebooks. Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents.
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Familiarity with global GCP, GVP, GMP. and GLP regulations. Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS, TraceLink, Veeva Vault and/or regulatory systems.
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Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
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Vendor experience preferred (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable.
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Knowledge and understanding of drug development including regulatory requirements and quality standards applicable to nonclinical and clinical laboratories (e.g., GLP, GCP, ISO). At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
$159,375 a yearExpandUpdated Today - UpvoteDownvoteShare Job
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Support entire GxP Quality Management systems encompassing all GxP functional departments (GMP, GLP, GCP, GVP, GDP as appropriate) to ensure compliance with applicable regulations and Rocket procedures.
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Summary The Scientist in the Nonclinical Disposition and Bioanalysis (NDB) within Nonclinical Research and Development (NCRD) will be responsible for executing all phases/aspects of the toxicokinetics (TK) support of toxicity studies [ie, exploratory and definitive/Good Laboratory Practice (GLP)], serving as a contributor scientist/principal investigator of toxicity studies, and executing pharmacokinetic (PK)/TK strategies to support the development of small molecules and biologics.
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Preferred vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors). Create biospecimen trackers using various tracking tools (MS Excel, Spotfire, Tableau, or Polaris) with support.
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0-3 years of relevant GMP/GLP laboratory experience in regulated industry preferred. Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
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Ensure compliance with cGMP, GLP, and FDA regulations and guidelines. - Strong knowledge of cGMP, GLP, and FDA regulations. - Prepare and review analytical reports, SOPs, and validation protocols in accordance with GMP and GLP guidelines.
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Excellent knowledge of current Good Clinical Practices (GCP) and Good Laboratory Practices (GLP), research ethics and applicable statutes and guidances in the pharmaceutical industry. Responsible for generation of key study documents and medical oversight of clinical study conduct; Collaborates closely with internal stakeholders, (i.e. Regulatory Affairs, Product Development, Research and Development (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs, etc.
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Minimum of 2-year experience working in an environment subject to FDA GLP/GMP regulations. Work with the test facility manager to implement the quality management system for the GLP/GMP bioanalysis organization.
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Additional areas of support focus on Research & Development, R&D functional areas, including Drug Safety and Pharmacovigilance (GvP), pre-clinical research, Good Laboratory Practices (GLP), and involvement in cross-functional process improvement projects with Subject Matter Experts (SMEs) of multiple functions in clinical research and other departments.
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Familiarity with industry-standard laboratory practices and Good Laboratory Practices (GLP) preferred. A bachelor's degree in Chemistry, Chemical Engineering, Cosmetic Science, or a related field.
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Knowledge of GCP, ICH, GLP and GMP. The position will report directly to the Vice President, Project Management & Regulatory Affairs in collaboration with the Senior Vice President & Chief Medical Officer to execute clinical trials in a safe, ethical, high-quality and efficient manner.
$180,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
glp job in Plainsboro, NJ
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