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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Strong laboratory skills and a high degree of attention to detail with the experience in following molecular biology and analytical techniques: PCR, gel electrophoresis, gel imaging, SDS-PAGE Mammalian cell culture, transfection, transduction (AAV) Nucleic acid preparation (DNA, RNA), ddPCR, qPCR and data analysis.
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This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
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Experience with mammalian cell culture, PCR, and related cell/molecular biology methods. Apply methods in cell biology, mammalian cell culture, molecular biology, and biochemistry to advance scientific projects.
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Performs clinical and research diagnostic and therapeutic molecular imaging protocols, inclusive of single photon and PET. The technologist must be able to perform diagnostic or attenuation correction Computed Tomography as ordered in conjunction with SPECT/PET exams.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. ·Identify and refer to community services, as indicated·Accesses and navigates the EMR to obtain essential information and documents CMRS progress notes and Resource Specialist Quick Notes per department standards.
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We're in search of a Scientist or Senior Scientist with expertise in synthetic biology, molecular biology, chemistry, or chemical engineering. A required PhD in synthetic biology, molecular biology, biochemistry, chemical engineering, or a related discipline, showcasing your strong academic background.
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As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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10-15 years experience with molecular imaging equipment: PET, PET/CT. CT, SPECT, and SPECT/CT required. Apply knowledge of mechanics, electronics, optics, computers, and products to the installation, preventive maintenance and repair of Imaging Equipment: PET, PET/CT, CT, SPECT, and SPECT/CT. You will cultivate superior customer relations to ensure contract stability and continued success.
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Job Title: Research Analyst Location: Cambridge, MA Duration: 12 months on Contract Top skills: Immunoassays experience and a working knowledge of virology, molecular biology, and/or immunology.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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Psivant is seeking a computational scientist with expertise in molecular simulations and drug discovery to join our dynamic, multidisciplinary team. Simulation and Analysis : Apply and analyze advanced molecular dynamics and free energy simulations to support drug design and biophysics experiments.
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Magnetic resonance imaging technologist, magnetic resonance imaging, MRI technologist, MRI tech, MRI equipment, magnetic resonance, MRI, allied, allied health. magnetic resonance imaging technologist, magnetic resonance imaging, MRI technologist, MRI tech, MRI equipment, magnetic resonance, MRI, allied, allied health.
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regulatory affairs specialist molecular imaging jobs Title: sr regulatory specialist in Cambridge, MA
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