Andrea Savio

Lead Medical Writer

Mississauga, Ontario

Email:
vCard: Download

Andrea Savio is a Lead Medical Writer at Intrinsik Corp. where she specializes in creating high-quality regulatory and scientific documents to support regulatory submissions. Andrea earned a PhD from the University of Toronto and completed postdoctoral training at the University of Toronto and brings this strong foundation in scientific research to her role at Intrinsik. As a Lead Medical Writer, Andrea is responsible for authoring and reviewing clinical sections of regulatory submissions, including INDs/CTAs and NDAs/NDSs. Her experience includes Clinical Study Protocols and Amendments, Clinical Study Reports, Module 2 summaries (Modules 2.5 and 2.7), and Investigator’s Brochures across a broad range of therapeutic areas. Andrea has also been responsible for systematic literature reviews in support of literature-based regulatory submissions, including Submissions Relying on Third-Party Data (SRTDs) for Health Canada.

Experience Highlights

Clinical sections of regulatory submissions (pre-IND, IND, pre-CTA, CTA, Investigator’s Brochures, NDA, NDS) for a broad range of therapeutic areas (e.g., infectious diseases, gastroenterology, genetic disorders, metabolism, neurology, pain management, rheumatology, vaccines, and rare diseases)

CTD-compliant Module 2 summaries (Modules 2.5 and 2.7)

Protocols and Clinical Study Reports
Product labelling (Product Monograph, Prescribing Information, Package Insert, Summary of Product Characteristics)
Risk Management Plans
Literature-based regulatory documents (e.g., SRTD-NDS)
Abstracts and manuscripts for publication

Education and Professional Qualifications

Postdoctoral Fellow, University of Toronto
Ph.D., Laboratory Medicine and Pathobiology, University of Toronto
B.Sc. (Honours), Biological Sciences, Brock University

Professional Affiliations

American Medical Writers Association

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).