Karen Moretti
Highly experienced in regulatory affairs/strategy, medical writing, and project management
Expertis...
New York City Metropolitan Area, New York City Metropolitan Area, United States
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Karen Moretti’s Email karen.moretti@iovance.com
Social Media
Karen Moretti’s Location New York City Metropolitan Area, New York City Metropolitan Area, United States
Karen Moretti’s Current Industry Iovance Biotherapeutics
Karen Moretti’s Prior Industry Pfizer | Transcelerate Biopharma | Bristol Myers Squibb | Bristol Myers Squibb Princeton New Jersey | Hoffmann La Roche | Encysive Pharmaceuticals | Westat | Theradex
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Work Experience
Iovance Biotherapeutics
Vice President, Head of Medical Writing
2023-01-01 00:00:00 - Present
Pfizer
Senior Director, Oncology Therapeutic Area Medical Writing Lead
2019-01-01 00:00:00 - 2020-11-01 00:00:00
Transcelerate Biopharma
Clinical Study Report Template Team Author
2018-01-01 00:00:00 - 2018-11-01 00:00:00
Bristol Myers Squibb
Group Director, Global Scientific & Regulatory Documentation; Global Regulatory, Safety & Biometrics
2014-06-01 00:00:00 - 2018-01-01 00:00:00
Bristol Myers Squibb Princeton New Jersey
Associate Director, Global Scientific & Regulatory Documentation; Global Regulatory, Safety & Biomet
2011-10-01 00:00:00 - 2014-06-01 00:00:00
Hoffmann La Roche
International Documentation (Medical Writing) Manager
2006-09-01 00:00:00 - 2011-10-01 00:00:00
Encysive Pharmaceuticals
Manager, Medical Writing
2003-08-01 00:00:00 - 2006-09-01 00:00:00
Westat
Senior Medical Writer/Senior Regulatory Affairs Associate
1999-05-01 00:00:00 - 2003-08-01 00:00:00
Theradex
Medical Writer
1997-12-01 00:00:00 - 1999-05-01 00:00:00Skills
Languages
FAQ About Karen Moretti
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Karen Moretti is located at
New York City Metropolitan Area, New York City Metropolitan Area, United States -
Karen Moretti is a Highly experienced in regulatory affairs/strategy, medical writing, and project management Expertise in US accelerated regulatory designations and approval pathways (eg, Fast Track, Breakthrough Therapy Designations, Orphan Drug Designations, Priority Reviews, Accelerated Approvals, Real-time Oncology Reviews [RTOR] & FDA Assessment Aids) Leader of a diverse team consisting of in-house team members, independent contractors, and Contract Research Organization (CRO) partners I remain an active writer to this very day! I proudly served as the lead medical writer for the clinical portion of the Biologics License Application (BLA) for the first cell therapy to treat patients with a solid tumor (AMTAGVI, lifileucel). These documents included the pivotal clinical study report, Summary of Clinical Safety (SCS), Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), Clinical Overview, Assessment Aid, 90-Day Safety Update, clinical responses to FDA information requests, and the clinical portions of the United States Package Insert (USPI).
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Karen Moretti currently works in the Iovance Biotherapeutics |
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No Languages Available
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Karen Moretti has prior
experience in the following industries:
Pfizer | Transcelerate Biopharma | Bristol Myers Squibb | Bristol Myers Squibb Princeton New Jersey | Hoffmann La Roche | Encysive Pharmaceuticals | Westat | Theradex -
Karen Moretti has the following professional experience:
Iovance Biotherapeutics | Pfizer | Transcelerate Biopharma | Bristol Myers Squibb | Bristol Myers Squibb Princeton New Jersey | Hoffmann La Roche | Encysive Pharmaceuticals | Westat | Theradex -
You can view Karen Moretti’s LinkedIn profile at LinkedIn URL
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Karen Moretti’s work email
addresses are
karen.moretti@iovance.com -
Iovance Biotherapeutics |
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