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.

• 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.

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.

• Medical Writing Experience
• Regulatory Document Preparation
• Advanced ICH Knowledge
• Microsoft Office Suite Proficiency
• Interpersonal Communication Skills

• Regulatory Document Preparation
• Medical Writing
• Statistical Analysis
• Scientific Interpretation
• Attention to Detail

• Interpersonal Skills
• Communication Skills

• Contract Research Organization
• Pharmaceutical Research
• Biotechnology Research
• ICH Guidelines

• Microsoft Office Suite
• Microsoft Word