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@Angiebiotech
Membre depuis le 27 juin 2018
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Angiebiotech

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I am a Regulatory Market Access and Medical Writing expert with 15+ years experience preparing pharmaceutical and combination product submissions. I am RAC certified, with multiple RAPS and AMWA publications, and a member of the government relations board for the American Society of Cell and Gene Therapy (ASGCT). I have experience in multiple therapeutic areas, with publications of my clinical trial work at ASCO (oncology), AJNR (neurology), and TCT (cardiovascular), and RSNA (radiology). I have extensive preparation experience in traditional and 505(b)2 NDA, MAA, IND, IDE, 510(k)/PMA/de novo, and recent experience in high demand fields like vitro diagnosstics and genomics, regenmed cell and gene, immunotherapy, and others. I have been leading FDA meetings/submissions and consulting on clinical development, regulatory issues, and commercialization/reimbursement for over 10 years.
$250 USD/hr
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Expérience

Regulatory Director

Nov 2017

Lead medical writing and regulatory projects

Senior Manager - Clinical Regulatory Medical Writing

Jun 2013 - Nov 2017 (4 years)

Medical and regulatory writing for a variety of clinical trials.

Senior Medical Writer

Jan 2010 - Jun 2013 (3 years)

Medical and regulatory writing for a variety of clinical trials.

Technical Writer

Jan 2007 - Jan 2010 (3 years)

Medical and regulatory writing for a variety of clinical trials.

Éducation

MSE

2003 - 2006 (3 years)

PhD

2013 - 2013 (1 month)

Qualifications

PMP Certification (2012)

Project Management Institute

Project Management Certification

RAC Certification (2012)

Regulatory Affairs Professionals Society

Regulatory consultant certification

Venture Capital Management Certificate (2010)

Università Bocconi

Certificate in venture capital market strategy

Publications

30+ Medical and Scientific Publications

See my Publication CV site

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