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Ashwini Tambe Email & Phone Number

Senior Specialist, Medical Devices at Medidata Solutions
Location: New York, New York, United States 12 work roles 2 schools
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Current company
Role
Senior Specialist, Medical Devices
Location
New York, New York, United States
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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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Email format at Medidata Solutions

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Medidata Solutions

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Profile bio

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.

Current workplace

Ashwini Tambe's current company

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Medidata Solutions
Medidata Solutions
Senior Specialist, Medical Devices
New York, NY, US
Website
Employees
2986
AeroLeads page
12 roles

Ashwini Tambe work experience

A career timeline built from the work history available for this profile.

Lead, Global Compliance And Strategy

Current

New York, NY, US

Apr 2024 - Present

Senior Specialist, Medical Devices

New York, NY, US

Jul 2021 - Apr 2024

Senior Specialist, Medical Devices

New York, NY, US

Apr 2021 - May 2021

Regulatory Affairs & Quality Assurance Intern

Redmond, WA, US

Aug 2020 - Mar 2021

Ra & Qa Intern At Usc International Consulting Center

Los Angeles, CA, US

  • 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
Aug 2019 - Sep 2020

Regulatory Affairs Intern

Micro Medical Devices Inc.
Jun 2020 - Aug 2020

Graduate Research Assistant

Los Angeles, CA, US

  • 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
Aug 2019 - Jun 2020

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
Jun 2017 - May 2019

Clinical Operations Specialist

Mumbai, Maharashtra, IN

  • 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
Nov 2016 - Jun 2017

Internship Trainee

Encore Healthcare Pvt. Ltd.

-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.

May 2015 - Jun 2015
Team & coworkers

Colleagues at Medidata Solutions

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2 education records

Ashwini Tambe education

Masters In Science, Regulatory Sciences

University Of Southern California

B.Pharmacy, B.Pharmacy

College Of Pharmacy, Solapur
FAQ

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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