Principal Medical Writer

Veristat•Quebec, ON

2d•Remote

About The Position

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.

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.

Nice To Haves

Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.

Responsibilities

Independently plan and prepare a range of regulatory documents and medical communications to support all phases of product development.
Organize, analyze, interpret, and present scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards.
Collaborate with cross-functional internal and external document production teams.