Senior Medical Writer
Phone: +1 905-364-7800
Robert Berger has over 6 years of experience as a Regulatory Toxicologist at Intrinsik Corp., specializing in reproductive health. As a Senior Clinical/Nonclinical Writer, Robert’s primary responsibility is 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. Robert also has experience authoring and reviewing CTD-compliant Module 2 summaries (i.e., Modules 2.4, 2.5, 2.6, and 2.7), Integrated Summaries of Safety and Efficacy, Protocols, and Clinical Study Reports. Robert has also been responsible for systematic literature reviews to support the preparation of literature-based regulatory documents, such as 505(b)(2) submissions in the United States and Drug Submissions Relying on Third-Party Data (SRTD) in Canada.
Robert has been involved in the design, implementation, monitoring and review of nonclinical studies (toxicology, safety pharmacology, genotoxicity, reproductive and development toxicity, carcinogenicity) in support of regulatory applications. He has also monitored nonclinical studies at CROs for quality and compliance with GLPs. He has submitted successful applications for several provincial and federal grants and has been a lead and co-author on a number of scientific publications.
- Authoring and reviewing clinical and nonclinical sections of regulatory submissions (pre-IND, IND, pre-CTA, CTA, IB, NDA, NDS) for a broad range of therapeutics (e.g., anticancer, corticosteroids, opioids, amphetamines, vaccines).
- Authoring and reviewing CTD-compliant Module 2 summaries (2.4, 2.5, 2.6, 2.7), ISSs, and ISEs.
- Authoring and reviewing Protocols and Clinical Study Reports.
- Authoring and reviewing literature-based regulatory documents (e.g., 505(b)(2) submissions).
- Monitoring nonclinical studies for scientific integrity and compliance with Good Laboratory Practices.
- Analyzing and interpreting toxicological data.
- Completion of nonclinical gap analyses.
Education and Professional Qualifications
- Ph.D., Psychology, McMaster University
- B.Sc. (Honours), Science, McMaster University
- American College of Toxicology
- Society of Birth Defects Research and Prevention
- Society of Toxicology