Ossie CarmiNir Email & Phone Number | Service provider: * Regulatory Medical Writer * Clinical Research Consultant Has >27 years progressive experience in regulatory medical writing and clinical research with variety of products (drugs, biologics, immunotherapies, gene therapies, combination products and diagnostics) Expertise in the following therapeutic indications: CNS, oncology (solid tumors and hematological malignancies), metabolic/gastrointestinal disorders, respiratory and allergy (including food allergy), anti-infective/vaccines, nephrology, dermatology, endocrinology, women's health, wound management, CVS , etc., including orphan drug designations Specialties: Regulatory medical writing - clinical study protocols (all study phases and variety of designs), clinical study reports (full and abbreviated formats), investigator's brochures, FDA briefing packages, clinical modules of regulatory submissions (IND/NDA/MAA in CTD format), IND annual updates, Orphan Drug Designation applications (US and EU), Breakthrough designation applications, FastTrack applications, DSURs, RMPs (EU, Canada, Australia and Japan), etc.

Ossie CarmiNir

Service provider: * Regulatory Medical Writer * Clinical Research Consultant Has >27 years progress...
San Diego County, California, United States

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Ossie CarmiNir’s Email ossie@tlr1.com

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Ossie CarmiNir’s Location San Diego County, California, United States

Ossie CarmiNir’s Current Industry Tlr Tech

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Managing Director, Medical Writing

2016-06-01 00:00:00 - Present

Clinical Operations Manager

2000-01-01 00:00:00 - 2005-09-01 00:00:00

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Ossie CarmiNir is a Service provider: * Regulatory Medical Writer * Clinical Research Consultant Has >27 years progressive experience in regulatory medical writing and clinical research with variety of products (drugs, biologics, immunotherapies, gene therapies, combination products and diagnostics) Expertise in the following therapeutic indications: CNS, oncology (solid tumors and hematological malignancies), metabolic/gastrointestinal disorders, respiratory and allergy (including food allergy), anti-infective/vaccines, nephrology, dermatology, endocrinology, women's health, wound management, CVS , etc., including orphan drug designations Specialties: Regulatory medical writing - clinical study protocols (all study phases and variety of designs), clinical study reports (full and abbreviated formats), investigator's brochures, FDA briefing packages, clinical modules of regulatory submissions (IND/NDA/MAA in CTD format), IND annual updates, Orphan Drug Designation applications (US and EU), Breakthrough designation applications, FastTrack applications, DSURs, RMPs (EU, Canada, Australia and Japan), etc.