Kathleen Mulderrig
Director, Global Medical Writing Team Lead @UCB
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WORK HISTORY
Director, Global Medical Writing Team Lead @UCB
Raleigh-Durham-Chapel Hill, NC, US
EDUCATION
Drexel University College of Medicine
MS, Clinical Research and Organization Mgt
Fox School of Business at Temple University
MBA, Chemistry Business
University of Delaware
Certificate, Business and Technical Writing
University of Scranton
BS, Biochemistry
SKILLS
ABOUT KATHLEEN MULDERRIG
15+ years experience in planning, preparation, and delivery of pharmaceutical submissions—NDAs, MAAs, and other global submissionsLed cross-functional delivery teams in production of submission documentsRegulatory documents written: FDA Advisory Committee Briefing Documents, Clinical Overview, Clinical Summaries of Efficacy and Safety, Integrated Summary of Safety, International Clinical Overviews, ASEAN CTD documents, Clinical Study Reports (Phase 1-4), Clinical Study Protocols (Phase 2-4), Investigator Brochure, Pediatric Investigational Plan, Investigational Medicinal Product Dossier, 4 Month Safety Update, IND documents, and global briefing packages and regulatory defense documents (US, EU, and ROW).Participated in FDA Advisory Committee Meeting regarding CRESTOR rosuvastatin calcium as slide partner, as well as having authored the Advisory Committee Meeting briefing book.
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