(Senior) Medical Writer

(Senior) Medical Writer

Biomapas

Remote, Europe

Medical 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.

Requirements:

• 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.

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