Ashwini Tambe Email & Phone Number
Who is Ashwini Tambe? Overview
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Ashwini Tambe is listed as Senior Specialist, Medical Devices at Medidata Solutions, a company with 2986 employees, based in New York, New York, United States. AeroLeads shows a matched LinkedIn profile for Ashwini Tambe.
Ashwini Tambe previously worked as Lead, Global Compliance and Strategy at Medidata Solutions and Program Committee Chair at Usc School Of Pharmacy. Ashwini Tambe holds Masters In Science, Regulatory Sciences from University Of Southern California.
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About Ashwini Tambe
Experienced professional specialist skilled in Citrix, Oracle and Clinical Trial Management Systems (TMF), being compliant with Good Clinical Practices and Good Documentation Practices. Pursuing masters in Regulatory Science at University of Southern California to make my foundation of regulatory knowledge grow stronger and actively looking for internship opportunities in Clinical or Regulatory domain.
Listed skills include Citrix, Trial Management, Good Clinical Practice, Ich Guidelines, and 4 others.
Ashwini Tambe's current company
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Ashwini Tambe work experience
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Lead, Global Compliance And Strategy
Current
Senior Specialist, Medical Devices
Senior Specialist, Medical Devices
Program Committee Chair
Regulatory Affairs & Quality Assurance Intern
Ra & Qa Intern At Usc International Consulting Center
- Preparing a Pre-IND meeting package for Orthopedic Stem Cell Gene Therapy
- Development of regulatory strategy for a medical device to determine the product code & find out the predicates
- Designing a regulatory submission pathway for drugs and medical devices through 510k, de novo etc.
- Drafting Standard Operating Procedures (SOPs) about patent evaluation and filing
Regulatory Affairs Intern
Graduate Research Assistant
- Creating and implementing the audit training systems to support investigator-initiated clinical trials
- Content writing for clinical trial modules (Auditing of Clinical Trials Module)
- Creating scripts for trial procedures with reference to ICH-E6, CFR, ISO 14155 guidelines
- Developing the graphical illustrations for the modules with Articulate 360
Etmf Process Specialist- Clinical Operations
- Provided documentation support for oncology, immunology, inflammation, HIV studies
- Ensured inspection readiness for MHRA audits
- Interacted with Sponsors and Investigators for smooth conduct of the trial
- Coordinated regulatory submissions for MHRA UK
Clinical Operations Specialist
- Certified QC of the process
- Updated various portal and databases used for clinical trial management (e-Track, Oracle, CARS)
- Performed competency and quality reviews of clinical trial documents
Internship Trainee
-Explored all the technical aspects of a pharmaceutical industry.-Worked with QA and QC departments and performed different analytical QC tests.-Visited packaging and storage departments and learned and worked on the software used for pharmaceutical product label designs- Operated small scale tablet manufacturing machines. Explored the techniques and.
Colleagues at Medidata Solutions
Other employees you can reach at mdsol.com. View company contacts for 2986 employees →
Christopher Bound
Colleague at Medidata Solutions
Doylestown, Pennsylvania, United States, United States
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DP
Dina Patel
Colleague at Medidata Solutions
Brooklyn, New York, United States, United States
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SR
Sreelakshmi Reddygari
Colleague at Medidata Solutions
United States, United States
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SB
Simone Betito
Colleague at Medidata Solutions
New York City Metropolitan Area, United States, United States
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DR
Denise Richard
Colleague at Medidata Solutions
United States, United States
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JO
Julie O'Brien
Colleague at Medidata Solutions
Ireland, Ireland
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NS
Nohemi Santollo
Colleague at Medidata Solutions
Houston, Texas, United States, United States
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PG
Payal Goel
Colleague at Medidata Solutions
Jacksonville, Florida, United States, United States
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SL
Stephen La Monica, Ms, Pmp
Colleague at Medidata Solutions
Greater Philadelphia, United States
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JK
Jinsoo Kim
Colleague at Medidata Solutions
South Korea, United States
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Ashwini Tambe education
Masters In Science, Regulatory Sciences
B.Pharmacy, B.Pharmacy
Frequently asked questions about Ashwini Tambe
Quick answers generated from the profile data available on this page.
What company does Ashwini Tambe work for?
Ashwini Tambe works for Medidata Solutions.
What is Ashwini Tambe's role at Medidata Solutions?
Ashwini Tambe is listed as Senior Specialist, Medical Devices at Medidata Solutions.
Where is Ashwini Tambe based?
Ashwini Tambe is based in New York, New York, United States while working with Medidata Solutions.
What companies has Ashwini Tambe worked for?
Ashwini Tambe has worked for Medidata Solutions, Usc School Of Pharmacy, Perimetrics, Llc, University Of Southern California, and Micro Medical Devices Inc..
Who are Ashwini Tambe's colleagues at Medidata Solutions?
Ashwini Tambe's colleagues at Medidata Solutions include Christopher Bound, Dina Patel, Sreelakshmi Reddygari, Simone Betito, and Denise Richard.
How can I contact Ashwini Tambe?
You can use AeroLeads to view verified contact signals for Ashwini Tambe at Medidata Solutions, including work email, phone, and LinkedIn data when available.
What schools did Ashwini Tambe attend?
Ashwini Tambe holds Masters In Science, Regulatory Sciences from University Of Southern California.
What skills is Ashwini Tambe known for?
Ashwini Tambe is listed with skills including Citrix, Trial Management, Good Clinical Practice, Ich Guidelines, Project Management, Regulatory Affairs, Pharmaceutical Manufacturing, and Microsoft Office.
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