Medical Writer

Job Description:

We are looking for an experienced and motivated Medical Writer to join our expanding team. As a medical writer at NoyMed, you’ll play a significant role in participating in vendor audits by presenting company work processes, participate in core process steps for clinical research documents’ development and systematic literature reviews, ensuring high quality and timely submission of all deliverables to clients, and more.

Responsibilities:

• Planning and execution of general medical writing activities/projects and systematic literature reviews for the assigned therapeutic area
• Researching, writing, and editing clinical research documents including but not limited to investigator’s brochure, study protocols, informed consent forms, clinical study reports, and scientific publications
• Participating in core process steps for clinical research documents’ development and systematic literature reviews including search, screening, data extraction, analysis, and synthesis of the literature and applicable materials
• Summarizing and interpreting results, including statistical parts, from the medical and scientific literature and clinical research materials and presenting them in a clear, concise, and scientifically accurate manner
• Organizing all medical writing activities in strict compliance with FDA/EMA or other regulations and guidelines and following their specific content/format/style requirements
• Demonstrating an understanding of assigned therapeutic areas, providing expertise, and interpreting clinical research methodology and study design, ensuring compliance with global regulations
• Ensuring high quality and timely submission of all deliverables to the client and acting as a contact person with the project manager or directly with the client for assigned medical writing activities/projects
• Develop/update company SOP/POL/WIs
• As an SME participating in vendor audits by presenting company work processes according to company SOPs
• Participate in technical interviews by evaluating candidates’ knowledge, experience, and compliance with position requirements
• Working in strict compliance with department and client policies and SOPs

Requirements:

• Medical Doctor/Pharmacist with practical and theoretical knowledge of fields of interest
• 3+ Years of relevant work experience
• Deep understanding of clinical trial processes and requirements (ICH GCP, Regulatory, etc.)
• Strong organizational, prioritizing, negotiating, analytical, and problem-solving skills
• Excellent interpersonal and leadership skills. Ability to work within the team and under pressure
• Strong verbal and writing communication skills, including public speaking ability
• Excellent knowledge of the English language, both written and verbal
• Excellent presentation skills
• Quick learner and self-starter, eager to learn and grow is an absolute MUST