As employee #18 at Biomarin, Cheri started in the lab in cell culture process development, eventually following her candidate’s progression by moving into clinical operations. “Having started in the lab it was remarkable to move along with the drug candidate through the development cycle, through phase 3 and approval.”
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Swiedler, S. J., Beck, M., Bajbouj, M., Giugliani, R., Schwartz, I., Harmatz, P., Wraith, J. E., Roberts, J., Ketteridge, D., Hopwood, J. J., Guffon, N., Sá Miranda, M. C., Teles, E. L., Berger, K. I. and Piscia-Nichols, C. (2005), Threshold effect of urinary glycosaminoglycans and the walk test as indicators of disease progression in a […]
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Giugliani R, Lampe C, Guffon N, Ketteridge D, Teles EL, Wraith JE, Jones SA, Piscia-Nichols C, Lin P, Quartel A, Harmatz P. 2014. Natural history and galsulfase treatment in mucopolysaccharidosis VI (MPS VI, Maroteaux–Lamy syndrome)—10-year follow-up of patients who previously participated in an MPS VI survey study. Am J Med Genet Part A 9999:1–12
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American Statistical Association annual meeting, Joint Statistical Meetings Roundtable topic: The transition to consulting statistician: how to successfully navigate the move and succeed. https://ww2.amstat.org/meetings/jsm/2020/onlineprogram/AbstractDetails.cfm?abstractid=309603
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I can build WordPress themes and plugins – MicrojobEngine – FreelanceEngine – DirectoryEngine
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Acted as a member of the CDM Leadership Team that addressed corporate CDM needs, strategies, and innovations, and subsequently implemented fit-for-purpose solutions across multiple companies within a large pharma/biotech organization.
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Extensive therapeutic area experience, including Anti-Infectives (bacteriology, mycology, virology – Hepatitis B and C), Oncology (solid tumor and hematological), Metabolic diseases, CNS, and Medical Device
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Developed and deployed an EDC global library of eCRFs to streamline study startup, development, testing, and cost while improving quality and consistency of trial data.
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As first Data Management hire at six companies, established entire DM strategy – assessed corporate needs, engaged vendors, hired staff, authored SOPs/Working Practices; established entire DM framework to support clinical development programs.
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• Lead 6 work teams to successful delivery of application • Met all deadlines in advance of application submission • Developed and Launched post submission team structure to support application defense
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• Lead three teams to right first time completion of remediation requirements • Received accolades from remediation guidance team for cohesiveness and timely completion • Completed one of three team projects early
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• Team member of successful launch at Wyeth- Right First Time • Team lead of successful launch at Novartis- Right First Time • Team lead for planning, warehousing, materials management and quality • System trainer, training developer, master data manager, troubleshooting • Lead change management improvements after initial launch leading to system upgrade
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• 2008 Best Practice award development and roll out of SAP BI reporting system. • Developed metric system using SAP BI tools • Developed training and corporate roll out plan • Streamlined three reporting tools into one reporting schema
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Experienced Regulatory Affairs Senior Associate, and strategist. Regulatory ANDA Filling and Review process, eCTD Review and publishing, resolving complex problems and maintain tracker and training for Regulatory affairs best practice guide line also for eCTD publishing tool.
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Integrated the TransCelerate Common Technical Protocol into sponsor’s eCTD templates. Used sponsor’s Starting Point templates as a base.
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Creation of over 200 instructional videos on common but thorny word problems such as Table Cell Alignment with Tabs & Indents, Header and Footer for Pages with Different Orientations, and Word Troubleshooting Numbered Headings.
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Team member for the establishment of a 500 staff operations hub in Tianjin China.
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Held leadership and success criteria roles for 4 enterprise level software development projects: CRFTrack (Boehringer Ingelheim) eCTDXPress (Novartis) ISIPublisher (J&J) Structured Content Authoring (Virtify) Each project included evidence-based user requirements, creative joint funding agreements, and close participation with product management and software development teams, including sprint schedules. Two of these four projects were wildly successful, […]
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