Kelly Dixon
Medical Writer (Director) @Pfizer
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WORK HISTORY
Medical Writer (Director) @Pfizer
US
EDUCATION
The University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Cell and Developmental Biology
Michigan State University
Bachelor of Science (B.S.), Biochemistry and Molecular Biology
SKILLS
ABOUT KELLY DIXON
Regulatory Medical Writer with over 15 years of science communication and project leadership experience in both academic and pharmaceutical sectors.PhD in Cell and Developmental Biology; BS in Biochemistry and Molecular Biology.Regulatory Medical Writing Experience:Protocols, Phase Clinical Study Reports, Investigator Brochures, Risk Management Plans, Briefing Documents, Regulatory Queries & Responses, Module 1.20 (GIP), Module 2 Summary Documents (SCE, SCS, CO), Posters, Manuscripts, Slide Decks, and QC of documents. IND, CTA, EUA, NDA, MAA, BLA submissions experience.Medical writing experience spans multiple therapeutic areas (Vaccines, Rare Disease, Oncology, CNS, GI, Metabolic Disease, Pain)-Regulatory Affairs Certification (RAC) granted by the Regulatory Affairs Professional Society (RAPS)-Industry experience in a GMP-compliant biopharmaceutical development laboratory at Pfizer-Demonstrated ability to manage multiple complex workstreams and deliver projects on time-Significant experience publishing and presenting technical scientific research to diverse audiences.
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