Principal Medical Writer

The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. Works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams. Requirements Bachelor’s degree required; science-related field preferred. Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. Advanced knowledge of ICH and related regulatory guidelines. Excellent written English and keen attention to detail. Strong interpersonal and communication skills. Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency. Core Competencies Demonstrates expertise in regulatory document preparation and medical communications, with a strong focus on ICH guidelines and advanced proficiency in Microsoft Word. Capable of analyzing and presenting scientific information while collaborating effectively with cross-functional teams. Highest-signal resume keywords Medical Writing Experience Regulatory Document Preparation Advanced ICH Knowledge Microsoft Office Suite Proficiency Interpersonal Communication Skills ATS Optimization Keywords Hard Skills Regulatory Document Preparation Medical Writing Statistical Analysis Scientific Interpretation Attention to Detail Soft Skills Interpersonal Skills Communication Skills Industry Keywords Contract Research Organization Pharmaceutical Research Biotechnology Research ICH Guidelines Tools & Technologies Microsoft Office Suite Microsoft Word #J-18808-Ljbffr