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Currentwww.greyscaling.comRegulatory Consulting for Drug Development
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@pfizer.com
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4 phones found area 212 and 201
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Diane Shoda is listed as Senior Advisor at LedgerDomain, based in Las Vegas, Nevada, United States. AeroLeads shows a work email signal at pfizer.com, phone signal with area code 212, 201, and a matched LinkedIn profile for Diane Shoda.
Diane Shoda previously worked as CEO at Greyscaling Llc and Clinical/Regulatory Consultant at Unlearn.Ai. Diane Shoda holds Bs, Chemical Engineering (X) from Massachusetts Institute Of Technology.
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* Building consensus amongst regulators & key stakeholders for development pathways* Leading cross-functional initiatives spanning clinical, safety, clinical supply, data management, project management and quality
Listed skills include Clinical Trials, Clinical Research, Pharmaceutical Industry, Clinical Development, and 12 others.
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www.greyscaling.comRegulatory Consulting for Drug Development
Las Vegas, Nevada, Us
LedgerDomain is an enterprise blockchain company working to bring fast, personalized, and secure transactions to the pharmaceutical supply chain. Their technology drives powerful mobile applications and executive dashboards that help deliver the right medications to the patients who need them.
San Francisco, California, Us
Unlearn.AI leverages AI-generated prognostic digital twins to enable smaller, more efficient pivotal clinical trials.
Cambridge, Ma, Us
New York, New York, Us
Global Regulatory Lead Lyrica. Responsible for developing and executing regulatory strategies for Lyrica, Pfizer’s top selling medicine. Leads regulatory subteam covering US, EU, Emerging Markets, Japan and Canada. Successes include:-Developed and executed creative regulatory strategy for pediatric epilepsy program valued over $1B. -Multiple 1st cycle Approvals for new indications (spinal cord injury, pediatric epilepsy) and controlled release formulation. -Gained agreement with ex-US health authority on a regulatory path forward to submit an application with a study that failed its primary endpoint.
New York, New York, Us
Global Regulatory Lead for Detrol LA, Toviaz, Viagra, Neurontin-Managed all regulatory aspects including lifecycle strategy, global advertising & promotion review, and compliance. Successes include overcoming multiple regulatory hurdles that led to industry's first virtual clinical trialUS Regulatory Lead for Cox-2s-Responsibilities included product defense and evaluating licensing opportunities
New York, New York, Us
Served on cross-divisional informatics board that oversaw a $200M budget and retired/consolidated 54 IT systems as part of the Pfizer/Pharmacia Integration.Led Clinical Supply Chain Integration leading to a Service Level Agreement resulting in improved planning and on-time performance for both the supply chain and clinical operations.
New York, New York, Us
Managed Clinical Data Operations process re-engineering projects through the deployment of new technology and related procedures. Successes include -Clearing backlog of closing out over 2500 studies utilizing CROs. Closed out more studies in 3 years than in the previous 10. -Established quality standards and processes that reduced Quality Assurance observations for clinical study reports by 60%.
New York, New York, Us
Oversaw development of Standard Operating Procedures (SOPs). Created more than 30 SOPs covering monitoring, data management, safety reporting and regulatory submission
New York, New York, Us
Developed and maintained clinical project plans. Responsibilities included negotiating timelines and resources.
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Diane Shoda works for LedgerDomain.
Diane Shoda is listed as Senior Advisor at LedgerDomain.
AeroLeads has found 2 work email signals at @pfizer.com for Diane Shoda at LedgerDomain.
AeroLeads has found 4 phone signal(s) with area code 212, 201 for Diane Shoda at LedgerDomain.
Diane Shoda is based in Las Vegas, Nevada, United States while working with LedgerDomain.
Diane Shoda has worked for Greyscaling Llc, Ledgerdomain, Unlearn.Ai, Massachusetts Institute Of Technology, and Pfizer.
You can use AeroLeads to view verified contact signals for Diane Shoda at LedgerDomain, including work email, phone, and LinkedIn data when available.
Diane Shoda holds Bs, Chemical Engineering (X) from Massachusetts Institute Of Technology.
Diane Shoda is listed with skills including Clinical Trials, Clinical Research, Pharmaceutical Industry, Clinical Development, Regulatory Affairs, Strategy, Cross Functional Team Leadership, and Creative Problem Solving.
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