As Director, Medical Writing, Robert Berger’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.
Experience Highlights
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
Professional Affiliations
American College of Toxicology
Society of Birth Defects Research and Prevention
Society of Toxicology
Join Our Team
Intrinsik Corp., is a dynamic science-based consulting firm. We are eagerly interested in professionals to add to our accredited staff base. Intrinsik is strongly committed to our employees by ensuring mentoring, training and advancement for those with a drive to succeed. Our areas of expertise include and are not limited to toxicology, human health and environmental risk assessment, biology, multi-media exposure modeling, environmental science, and risk management.
Diversity is not only part of our company’s culture, it is a core business strategy. We are building a workforce that is representative of our society, and our programs and policies are designed to foster diversity and inclusion.
AODA Declaration
Our goal is to create an environment that is inclusive to all members of the community. Intrinsik Corp., focuses on identifying, removing, and preventing barriers for persons with disabilities, and our policy complies with the Accessibility for Ontarians with Disabilities Act, 2005 (AODA).
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