Medical Writer

Main activities may include but are not limited to:

• Writing, editing and review of clinical documents, including, clinical development plans, study synopses, investigator brochures, study protocols, informed consent forms, patient information, interim and final clinical study reports, safety update/aggregate reports, and other project-specific clinical documentation;
• Ensuring quality and compliance of essential study documents with applicable QSDs, pertinent regulatory requirements, and client specifications;
• Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues;
• Consulting study team on the study protocol related questions;
• Collaboration with statisticians and data managers regarding sample size estimation, data issues and data analysis, review of SAPs and TFLs, participation in data listings review;
• Reviewing scientific literature pertinent to medical writing activities;
• Coordinating production and distribution of draft and final documents to project team and client;
• Participation in local and international medical writing conferences and trainings.

Requirements:

• Degree in Medicine or Life Sciences; PhD or Dr of Medical Sciences;
• Experience in writing scientific or clinical study documents: articles, scientific works, protocols, IBs, ICFs, clinical study reports;
• Experience in oncology projects is a plus;
• Basic knowledge and understanding of statistics;
• Excellent interpersonal, verbal and written communication skills;
• Client focused approach to work;
• Understanding of clinical research, the drug development process, and applicable regulatory guidelines;
• Fluency in English (written and spoken) is required.

We offer:

• Challenging job in a highly qualified team;
• Employee-friendly work environment;
• Competitive salary;
• Professional growth in clinical research field.