Lalitha Jonnavithula, Mba

Lalitha Jonnavithula, Mba Email and Phone Number

Driving solutions using expertise, process improvement, collaboration and a sprinkling of humor @ Criterion Edge
san luis obispo, california, united states
Lalitha Jonnavithula, Mba's Location
San Francisco Bay Area, United States
Lalitha Jonnavithula, Mba's Contact Details

Lalitha Jonnavithula, Mba personal email

n/a
About Lalitha Jonnavithula, Mba

Criterion Edge began with a simple yet powerful vision: to deliver unparalleled regulatory writing services that enhance the quality of healthcare products through rigorous compliance and scientific excellence. We pride ourselves on a foundation built upon the pillars of expertise, collaboration, quality, and scalability, ensuring that we not only meet but exceed the evolving needs of our clients. Founded in response to the increasingly challenging regulatory environment within the pharmaceutical, in-vitro diagnostic device and medical device industries; Criterion Edge has established itself as a leading provider of medical, scientific, and regulatory writing services. Our founders, equipped with decades of industry experience, recognized the growing need for specialized expertise to navigate stringent global regulations and developed a unique approach to providing industry leading regulatory writing and safety services.

Lalitha Jonnavithula, Mba's Current Company Details
Criterion Edge

Criterion Edge

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Driving solutions using expertise, process improvement, collaboration and a sprinkling of humor
san luis obispo, california, united states
Website:
criterionedge.com
Employees:
33
Lalitha Jonnavithula, Mba Work Experience Details
  • Criterion Edge
    Chairman Of The Board
    Criterion Edge Jul 2018 - Present
    San Luis Obispo, California Area
    Leads a global group of talented medical, regulatory and safety writers. Our clients are Fortune 500 companies across the health care sector- pharmaceutical, medical device and biotech. Our unique approach provides state of the art solutions in a changing regulatory landscape. Experience in analyzing complex clinical data powers our output.
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  • Morphes, Llc
    Clinical Research Consultant
    Morphes, Llc Jan 2018 - Jul 2018
    San Jose, Ca
    Provided clinical operations and financial services to small and mid size companies in the medical device, pharmaceutical and financial sectors.
  • Abbott
    Global Regulatory Operations
    Abbott Oct 2016 - Jan 2018
    Santa Clara, Ca
    Post marketing surveillance activities focused on Regulatory, Risk Management and Clinical Evaluations-RML, CEP, CER, PSUR, PMCF, SSCP, etc. Extensive training on MedDev 2.7/ 1 Rev 4, MDR, ISO 13485, ISO 14971.
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  • Abbott Vascular Devices
    Associate Director
    Abbott Vascular Devices Jul 2010 - Oct 2016
    Santa Clara
    Managed global safety group supporting the entire clinical trial portfolio in endovacscular and cardiovascular. Successfully achieved regulatory approvals in North America, EMEA, Asia Pac and Japan.Created innovative outsourcing solutions.
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  • Abbott
    Senior Manager
    Abbott Jan 2009 - Jul 2010
    Santa Clara, Ca
    Managed a global safety group of RNs, MDs and operations staff focused on cardiovascular trials.
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  • Abbott
    Principle Project Manager
    Abbott Feb 2006 - Dec 2008
    Santa Clara, California
    Managed, and delivered a pivotal RCT DES trial through FDA approval. This stent has an unmatched safety profile. Product was subsequently approved in 35 + countries and is still the leader in its class world wide.
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Lalitha Jonnavithula, Mba Skills

Clinical Development Pharmaceutical Industry Gcp Fda Clinical Trials Ctms Cro Medical Devices Biotechnology Edc Project Management Oncology Cardiology Regulatory Affairs Life Sciences Regulatory Submissions Good Clinical Practice U.s. Food And Drug Administration Clinical Trial Management System Cro Management Electronic Data Capture

Lalitha Jonnavithula, Mba Education Details

Frequently Asked Questions about Lalitha Jonnavithula, Mba

What company does Lalitha Jonnavithula, Mba work for?

Lalitha Jonnavithula, Mba works for Criterion Edge

What is Lalitha Jonnavithula, Mba's role at the current company?

Lalitha Jonnavithula, Mba's current role is Driving solutions using expertise, process improvement, collaboration and a sprinkling of humor.

What is Lalitha Jonnavithula, Mba's email address?

Lalitha Jonnavithula, Mba's email address is lj****@****ant.com

What schools did Lalitha Jonnavithula, Mba attend?

Lalitha Jonnavithula, Mba attended Mcgill University.

What skills is Lalitha Jonnavithula, Mba known for?

Lalitha Jonnavithula, Mba has skills like Clinical Development, Pharmaceutical Industry, Gcp, Fda, Clinical Trials, Ctms, Cro, Medical Devices, Biotechnology, Edc, Project Management, Oncology.

Who are Lalitha Jonnavithula, Mba's colleagues?

Lalitha Jonnavithula, Mba's colleagues are Emily Garcia, Phd, Janice Odell, Sandesh Krishna Katar, Sara Baldridge, Alexis S., Nunavath Lakshmi, Suraj Pasunoori.

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