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 ICH and other regulatory guidelines.
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.

Principal Medical Writer

Key skills