Completes assignments independently or for more complex documents, under guidance of a mentor
Authors a range of clinical documents, including regulatory documents following defined templates
Ensures high integrity of data interpretation, following negotiation with document team
Actively participates in all planning, coordination and review meetings
Ability to work on 2-3 assignments simultaneously
Proactively raises and discusses concerns/issues in an open and timely manner

Requirements

Up to 5 years clinical regulatory writing experience in the pharmaceutical industry
Possesses a good understanding of basic drug development
Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)
Possesses necessary computer skills and general computer literacy
Excellent English language skills (verbal and written)

Benefits

Private healthcare
Additional paid days off
Life insurance
Private pension plan
Fully paid parental leave & care of family member leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical regulatory writingdata interpretationscientific methodologystatistical principlesdrug developmentGood Clinical Practice (GCP)International Committee for Harmonisation (ICH)computer skillsgeneral computer literacyEnglish language skills

Soft Skills

independent workplanningcoordinationreview meetingsmultitaskingproactive communicationissue resolution