Nicole Day, PhD
Medical Writer at MedVal Scientific Information Services, LLC- Claim this Profile
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Bio
Credentials
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GCP for Clinical Trials with Investigational Drugs and Medical Devices - U.S. FDA Focus
University of Miami Leonard M. Miller School of MedicineOct, 2015- Nov, 2024 -
SciPhD Business Training for Scientists
University of California, BerkeleyAug, 2015- Nov, 2024
Experience
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MedVal Scientific Information Services, LLC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Medical Writer
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Jan 2022 - Present
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Associate Medical Writer
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Nov 2020 - Jan 2022
Therapeutic area experience: epilepsy, nonalcoholic fatty liver disease, thyroid eye disease, myasthenia gravis, Cushing syndrome/disease, metastatic cancer, non-Hodgkins lymphoma, polycythemia vera, and myeloproliferative neoplasms.
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Self-Employed
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Greater Denver Area
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Scientific Consultant
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Aug 2016 - Oct 2020
NCS America, Inc: Assisted medical corporation with development of technical communications and protocols for evaluating biometric 3-D tracking technology platform used in orthopedic treatment. Novix Medical Inc, Puradigm: Developed clinical trial protocol for ion-cluster air purification system for medical application in university hospitals. NCS America, Inc: Assisted medical corporation with development of technical communications and protocols for evaluating biometric 3-D tracking technology platform used in orthopedic treatment. Novix Medical Inc, Puradigm: Developed clinical trial protocol for ion-cluster air purification system for medical application in university hospitals.
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University of Colorado Anschutz Medical Campus
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United States
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Higher Education
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700 & Above Employee
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Research Associate
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Feb 2017 - Jun 2019
Conducted translational research investigating the contribution of the brain's microenvironment to development and growth of breast cancer-to-brain metastases: specifically, evaluated the involvement of IL13Ra2 (interleukin-13 receptor alpha 2) in promoting metastatic tumor burden. Managed the daily operations of the laboratory, including training students and research staff, maintaining compliance with regulatory requirements, creating and updating databases, corresponding with collaborators, tracking drug usage for DEA logs and records, liaising with the Neurosurgery department for procurement of clinical samples, and filing SOPs for experimental drug use. Show less
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Nuventra Pharma Sciences
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Project Management and Clinical Pharmacology Specialist
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Nov 2015 - Jul 2016
Assisted in executing and analyzing nonclinical and clinical pharmacology studies. Regulatory affairs experience included work on NDAs, ANDAs, BLAs, INDs, and other regulatory documents. Medical/scientific writing experience included PK study reports, clinical study reports, and clinical protocols. Specifically: • Reviewed, formatted, and conducted QC on clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology sections of NDAs and BLAs, and Investigator Brochures. • Finalized PK/PD deliverables for clients • Managed deliverables and milestones for 40 projects, including personnel and resource allocation • Tracked project scope, budgets, and timelines • Maintained high-level timelines with input from functional departments and clients • Served as member of project teams to ensure that functional deliverables were supplied on time, on budget, and according to quality standards • Coordinated and led project team meetings both internally and externally • Sought timely progress for action items and resolution to issues identified on projects • Acted as a point of contact for clients and Nuventra team members across multiple projects • Assisted with proposal development for clients and management of budgets and contracts Show less
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University of California, San Francisco
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United States
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Higher Education
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700 & Above Employee
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Postdoctoral Scholar
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Dec 2014 - Oct 2015
Evaluated activation of the integrated stress response (ISR) following traumatic brain injury (TBI) in multiple injury models and determined the effects of a novel small molecule inhibitor of the ISR, ISRIB, on TBI-induced cognitive dysfunction. Collaborated within UCSF and externally with industry. Evaluated activation of the integrated stress response (ISR) following traumatic brain injury (TBI) in multiple injury models and determined the effects of a novel small molecule inhibitor of the ISR, ISRIB, on TBI-induced cognitive dysfunction. Collaborated within UCSF and externally with industry.
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University of Alabama at Birmingham
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Higher Education
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700 & Above Employee
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Doctoral Candidate
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2012 - Sep 2014
Elucidated the signaling mechanisms underlying neuroprotection in hippocampus and cortex conferred by administration of the G protein-coupled estrogen receptor 1 (GPER) agonist G-1 in models of traumatic brain injury.
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Graduate Research Assistant
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Mar 2009 - May 2012
Investigated the neuroprotective effects of administration of 17beta-estradiol (E2), Memantine (MEM), MEM + E2, and the specific GPER agonist G-1 in hippocampus and cortex in a rodent model of moderate-severe traumatic brain injury.
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Teaching Assistant, Science and Technology Honors Program
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2011 - 2012
Course: Disorders of the Nervous System *Facilitated course, graded assignments, mentored undergraduates in crafting NRSA-style proposals*Lectured on biomechanics and pathophysiology of brain injury, animal models, and grant writing
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Graduate Student, Cellular & Molecular Biology
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Jun 2008 - Feb 2009
Completed three lab rotations in the Department of Neurobiology: *Under Dr. Robin Lester: practiced technique of patch clamp electrophysiology in the medial habenula*Under Dr. Candace Floyd: characterized the C5 cervical hemicontusion spinal cord injury model*Under Dr. Linda Overstreet-Wadiche: used the gramicidin perforated-patch clamp technique in the context of studying GABAergic signaling in newborn granule cells of the dentate gyrus
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Student Research Assistant
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Aug 2007 - Jun 2008
*Undergraduate project: utilized flow cytometry to characterize the transmembrane receptor TLT2 in human peripheral blood.*Responsible for maintenance of lab equipment, supplies, and glassware, culturing hybridomas, antibody purification, phenotyping transgenic mice, managing chemical inventory, and supporting postdoctoral fellow and graduate students in meeting project milestones.
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Education
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University of Alabama at Birmingham
Doctor of Philosophy (Ph.D.), Neuroscience -
University of Alabama at Birmingham
B.S., Molecular Biology, minor in Chemistry -
University of Kansas
Bachelor of Arts - BA