Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
7 Years
Description
The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
The primary responsibilities of the position are 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.
The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.
Qualifications
Highest qualification: University
- 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. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
- 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.