Ana Iglesias is a Director of Medical Writing at Intrinsik Corp. Ana’s primary responsibility is the strategic oversight, authoring, and review of clinical documents for a wide array of regulatory submissions. With nearly 20 years of experience, Ana specializes in managing the preparation of complex dossiers, including briefing packages, IND/CTA, NDA/NDS, and MAA filings, as well as other documents such as Orphan Drug Designations (ODD), Fast Track/Breakthrough, Pediatric Plans, and Investigator’s Brochures across diverse therapeutic areas. Ana brings a comprehensive understanding of the drug development process, from the conceptualization of clinical protocols to successful marketing applications. Ana has extensive experience developing CTD-compliant Module 2 summaries (Modules 2.5 and 2.7) and Integrated Summaries of Efficacy and Safety. Her expertise also extends to literature-based pathways, including 505(b)(2) submissions in the United States and Submissions Relying on Third-Party Data (SRTD) in Canada.
In addition to her technical role, Ana is involved in leading the Intrinsik Medical Writing and Proposals teams, where she contributes to business development by cultivating client relationships, managing partnerships, and preparing proposals.
Experience Highlights
Authors and reviews clinical sections of regulatory submissions (pre-IND, IND, pre-CTA, CTA, IB, NDA, NDS, MAA) for broad range of therapeutics.
Authors and reviews CTD-compliant Module 2 summaries (Modules 2.5 and 2.7), ISSs, and ISEs.
Authors and reviews Protocols and Clinical Study Reports.
Authors and reviews literature-based regulatory documents (e.g., 505(b)(2) submissions and SRTDs).
Prepares data gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.
Manages clients and subcontractors to oversee scientific integrity, timelines, and budgets.
Education and Professional Qualifications
B.Sc. (Honours), Biomedical Toxicology, University of Guelph
Professional Affiliations
American Medical Writers Association
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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