Overview

“NoyMed LLC” is looking for a “Medical Writer”.

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
- Required qualifications

Required Qualifications:


- 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

About NoyMed LLC

NoyMed is a Contract Research Organization providing Data Management, Statistical Programming, Biostatistics to Pharma, Biotechnology and Medical Device Industries worldwide and a part of Margasoft company.
Having many years of experience processing