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And minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility.
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This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.
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Chemistry is a core capability in Small Molecule & Drug Discovery (SMDD) with innovative scientists working in medicinal chemistry, radiochemistry, analytical chemistry, and large-scale synthesis.
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This Co-Op Associate Scientist will be exposed to a wide variety of phsiochemical assays (U/HPLC, Capillary Electrophoresis, DLS, DSC, subvisible particle analyses) and drug product development processes (including clinical in-use studies, photosensitivity studies, protein deep characterization, and drug product stability studies), and work on sample testing, method transfer, optimization and development.
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Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational, Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines.
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Qualifications & Experience:MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Incumbents with a Master's degree in counseling or social work not possessing any of the qualifications specified in (a) above shall obtain LCADC status by December 1, 2022, or another health professional license that includes diagnostic and supervisory authority for work of an alcohol and drug counseling nature.
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For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Strong command of the drug development process, regulatory environment, and legal and compliance regulations governing Medical Affairs activities is required.
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NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing.
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NRG is seeking a VP, Data Privacy to join our legal team and lead the management of our Data Security across the organization, including customer privacy. The ideal candidate will be a lawyer with expertise in privacy, security, and financial services that is familiar with the evolving law and regulations around the country, can draft and negotiates data processing and security agreements, as well as think strategically around data usage across our businesses.
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Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as global regulatory guidelines as they pertain to drug safety/pharmacovigilance (PV.
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The candidate will be charged with understanding the observational data needs and opportunities to enhance drug development with the mRNA platform, and build expertise as needed within the Rare Disease portfolio.
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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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The scientist in this role will establish a preclinical immunoscience focused Quantitative Systems Pharmacology (QSP) capability to support discovery and early drug development efforts. Demonstrate high proficiency in the development and application of Quantitative Systems Pharmacology (QSP) models to address drug discovery and development questions.
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drug screen jobs Title: security guard in Monmouth Junction, NJ
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