Robert Berger
Senior Clinical Nonclinical Writer at Intrinsik Corp. - Pharmaceuticals & Biotechnology
Based in Mississauga, Canada
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Seniority
Staff
Department
Other
Location
Mississauga
Industry
Pharmaceutical Manufacturing
Company size
48
Contact information
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r•••••••@intrinsik.com
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Background
About Robert Berger
I am currently a Regulatory Toxicologist and Clinical/Nonclinical Writer at Intrinsik. My primary responsibilities include authoring and reviewing clinical and nonclinical sections of regulatory submissions, including pre-IND/pre-CTA, IND/CTA, NDAs/NDSs, and investigator’s brochures for a broad range of therapeutics. I have experience in authoring and reviewing eCTD-compliant Module 2 summaries (i.e, Modules 2.4, 2.5, 2.6, and 2.7), as well as Integrated Summaries of Safety and Efficacy. I have a strong scientific writing background, having authored/co-authored over 20 peer-reviewed publications.
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