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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
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The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products (mainly investigational) throughout their lifecycle.
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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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This is an exciting opportunity as we combine the best of physics-based modeling with data analytics and machine learning to accelerate drug discovery and bring benefit to patients. In this role, the selected candidate will use cutting edge techniques to accelerate the drug discovery process from hit identification through candidate nomination and will actively participate directly on therapeutic projects.
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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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As an Associate Director, Biostatistician , you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development, including clinical development plan and regulatory submission strategy.
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Actively counsel members of R & D such as Clinical Development, CMC and other departments to identify new inventions as well as devise and implement strategies for patent protection and publication throughout all phases of drug development and commercialization.
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Provide strategic CMC regulatory expertise for development project teamsProvide strategic input to development & GO teams to mitigate drug supply issues. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.
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A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters.
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Significant experience in pharmaceutical/biotechnology and extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical trials.
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Experience with a Call Center and Drug Safety database preferred. Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety information.
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Prime Benefits: First Day Medical, Dental, Vision and Rx benefits Housing and Meal stipends 401(k) Savings plan after 90 days Travel/Licensure Reimbursement Referral Bonus Plan Weekly Direct Deposit Qualifications: Current BLS (AHA Preferred) Active State License Supervisory Professional References Must complete Drug Screen and Background Screen Submit your resume and experience the Prime difference or call for more details.
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Understanding of the digital health field and clinical drug development. Liaise with Regulatory Affairs, Legal, Patient Engagement, Drug Development IT, Clinical and Medical teams on developing endpoint qualification strategy.
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drug screen jobs Title: associate Company: Fuyao Glass America in Monmouth Junction, NJ
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