Job Description
Join our Regulatory Affairs department as a Medical (Scientific) Writer. Position is in any EU country.
Medical (Scientific) Writer is responsible for the preparation of various documents used in clinical research and marketing authorization of medicinal products.
Role responsibilities:
Prepare documents for marketing authorization of medicinal products (CTD modules 2.4, 2.5, 4, 5) and clinical research across all phases (study protocols and reports, Informed Consent Forms, Investigator’s Brochures, etc.), including writing, QC, resolving reviewers comments
Write manuscripts for scientific journals
Research on topics relevant to assigned projects
Communicate and co-operate with other team members and clients
Contribution to process improvements
Master or higher degree in Medicine, Pharmacy, Public Health or Life Sciences
Fluent written and spoken English
+2 years previous regulatory medical writing experience (including writing for clinical studies)
Knowledge of EMA and ICH guidelines relevant to clinical research and marketing authorization
Good understanding of basic human anatomy and physiology
Basic knowledge of biostatistics
Continuous professional learning and development
Analytical skills to understand, analyze, interpret, and present scientific data
Attention to details
Ability to prioritize and work to deadlines with high quality
Ability to work independently and within the team
International team and environment
Professional growth and career opportunities
Bonus based on annual performance
Additional bonus system – Instant reward and Recognition program
Personal accident and business trip insurance
Additional health insurance
Workplace establishment allowance (only fully home-based)
Influenza vaccines
Rewarding referral policy
Remote work possibility & flexible working hours
