Inés Abela Hofbauerová
Medical Writer Ii @Certara
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WORK HISTORY
Medical Writer Ii @Certara
Experience as the lead medical writer: CSRs, Investigational Brochures, IB updates, Protocols, Protocol Amendments, Patient Safety Information (PSI) updates, Experience as the support medical writer: Meeting requests, Briefing Packages, Submission documents (2.7.1, 2.7.2, 2.7.3, 2.7.4).• Leaded the planning, coordinating, and writing of clinical and regulatory documentation.• Authored documents and guided client teams through the document creation process, per client specifications, templates, style guides, regulatory guidelines and requirements.• Acted as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents.• Practiced problem solving, taking broad perspectives in resolving issues to prevent negative impact to work.• Managed budget for low to high complexity projects, including all contributors.• Ushered documents through the review process, conducted comment resolutions meetings (CRMs), and successfully lead a project team to consensus.• Leaded and participated in project-related meetings.• Regulatory Services Employee Council member.
EDUCATION
Charles University
Master's degree, Ecology
Universidad de Jaén
Bachelor's degree, Biology, General
Universitat de Barcelona
Ph.D., Plant ecology
Charles University
Ph.D., Plant ecology
ABOUT INÉS ABELA HOFBAUEROVÁ
Dr. Inés Abela Hofbauerová, PhD from Charles University in Prague, brings over 18 years of expertise in medical writing, publishing, and research.She has extensive expertise in the pharmaceutical industry, working as both a medical writer and regulatory/start up specialist. Her medical writing portfolio includes over five years of professional experience with protocols, protocol amendments, investigator brochures (IBs) and updates, clinical study reports (CSRs), submission-level documents (2.7.1, 2.7.2, 2.7.3, 2.7.4), patient narratives, and post marketing safety reports.Inés also brings editorial leadership as the managing editor of a bimonthly, open access scientific journal. Published in peer reviewed journals and presented at international conferences, her biology research results are complemented by fellowships in the USA and Spain.She began her academic journey in Spain and continued her studies in the Czech Republic. After completing her studies, she built a solid professional career across Spain, the Czech Republic, and Germany, which provides her with a strong international background that enriches her scientific perspective and adaptability in diverse professional environments.With 23 years of international experience, she is fluent in Spanish, English, Czech, and Catalan. She has demonstrated strong skills by delivering regulatory documents under tight deadlines, applying analytical thinking to resolve client requests, and maintaining clear communication with clients to align project expectations and outcomes.Her blend of scientific expertise and client focused communication ensures the smooth execution of international projects and outstanding deliverables.
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