Ossie Carmi-Nir
Managing Director Regulatory Medical Writing at TLR Tech, LLC
- Role
- Managing Director, Medical Writing Department at Tlr Tech Ltd
- Location
- San Diego County, CA, US
- LinkedIn followers
- 500 followers
About Ossie Carmi-Nir
Service provider:* Regulatory Medical Writer* Clinical Research ConsultantHas >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 designationsSpecialties: 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.
Experience
Managing Director, Medical Writing Department
Sep 2005 — Present
Provide professional medical writing services (regulatory, pharmacovigilance, clinical research) to pharma, biotech, medical device, CRO and medical centers (investigator-initiated studies).
Education
University of California, Riverside
BSc, Psychobiology
UC Irvine
PhD, Neurobiology and Behavior
1996
Skills
- Hematology
- Medical Writing
- Endocrinology
- Dermatology
- Regulatory Submissions
- Immunology
- Cardiology
- Clinical Development
- Neuroscience
- Clinical Trials
- Biotechnology
- Regulatory Affairs
- Therapeutic Areas
- Pharmacology
- Protocol Development
- Ich-Gcp
- Neurology
- Oncology
- Protocol
- Drug Development
- Cancer
- Gcp
- Biopharmaceuticals
- Study Design
- Good Clinical Practice (Gcp)
- Regulatory Requirements
- Risk Management Plans
- Ind
- Respiration
- Gastroenterology
- Protocol Writing
- Pharmacovigilance
- Eu Rmp
- Vaccines
- U.s. Food and Drug Administration (Fda)
- Medicine
- Biologics
- Rheumatology
- Clinical Study Design
- Central Nervous System
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