💊 Medical Writer (Pharmaceutical) | Remote | $30–$60/Hour | Remote Openings 30

💊 Medical Writer (Pharmaceutical) | Remote | $30–$60/Hour | 30 Openings Posted by micro1 micro1 is engaging experienced Medical Writers / Clinical Document Authors to participate in a customer project focused on developing advanced AI-assisted writing tools for clinical documentation. This remote contractor opportunity is designed for professionals with strong experience in regulatory medical writing, clinical study reports, pharmaceutical documentation, and clinical data interpretation. 🤖 No prior AI experience is required. Your medical writing and clinical documentation expertise will be used to help train and evaluate next-generation AI systems. 📌 Job Overview Job Detail Information 🏢 Company micro1 💼 Position Medical Writer (Pharmaceutical) 📋 Job Type Contractor 🌍 Location Remote 👥 Openings 30 💰 Pay $30–$60/hour 🤖 AI Experience Not required 🎯 Experience 5+ years preferred 📝 About the Role As a Medical Writer (Pharmaceutical), you will apply your regulatory medical writing expertise to help develop and evaluate AI-assisted clinical documentation tools. You will work with documents such as Clinical Study Reports (CSRs), DSURs, PSURs/PBRERs, and related clinical documents. Your role will involve assessing AI-generated content for scientific accuracy, regulatory structure, source-data support, and overall quality. Your expert feedback will help improve how AI systems draft, review, and interpret clinical regulatory documentation. 🔍 Scope of Work 1. ✍️ Clinical Document Authoring & Review Author and review realistic evaluation tasks based on: Clinical Study Reports (CSRs) Development Safety Update Reports (DSURs) Periodic Safety Update Reports (PSURs) Periodic Benefit-Risk Evaluation Reports (PBRERs) Related clinical and regulatory documents 2. 📑 Clinical Structure & Regulatory Assessment Evaluate AI-generated documents against clinical and regulatory requirements, including: ICH E3 organization Section sequencing Clinical document structure Cross-referencing Appendix management Template requirements 3. 🧪 Scientific Accuracy Assessment Review narrative sections such as: Efficacy summaries Safety summaries Discussion sections Conclusions Clinical interpretations You will distinguish genuine scientific or interpretive errors from differences that are primarily stylistic. 4. 📊 Source Data Verification Trace narrative claims back to their supporting source records, including: Tables Figures Listings Clinical protocols Clinical study data The objective is to verify that statements and conclusions are appropriately supported by the underlying data. 5. 📝 Structured Feedback Provide clear and detailed written rationales explaining your assessments. Your feedback will help project teams identify: Scientific errors Data inconsistencies Regulatory structure issues Unsupported claims Areas where AI-generated content needs improvement 6. 🤝 Framework Development Collaborate with project leads to refine: Evaluation frameworks Regulatory writing standards Clinical documentation best practices AI evaluation criteria Quality assessment processes 🎓 Preferred Qualifications 💼 Professional Experience Minimum 5 years of regulatory medical writing experience. Experience working for a pharmaceutical sponsor, CRO, or as an independent consultant. Experience independently authoring or leading the authoring of full Clinical Study Reports (CSRs). 📚 Regulatory Knowledge Strong knowledge of: ICH E3 ICH E2F ICH E2C eCTD (Electronic Common Technical Document) Regulatory medical writing conventions Clinical documentation requirements 📊 Clinical Data Skills Experience reading and interpreting: Tables Figures Listings (TFLs) Clinical protocols Clinical study data Applicants should be able to identify situations where the written narrative does not accurately reflect the underlying source data. ✍️ Communication Skills Excellent written and verbal communication skills, particularly the ability to provide: Structured feedback Clear explanations Actionable recommendations Detailed clinical content assessments 🎓 Educational Background An advanced degree in a relevant field is preferred, including: PhD PharmD MD MSc Life Sciences Pharmacy Medicine Equivalent depth of professional authoring experience may also be considered. 🩺 Therapeutic & Clinical Experience Experience across multiple: Clinical phases Therapeutic areas Clinical documentation types is preferred. ⭐ Particularly Valuable Experience 🧬 Oncology 🩸 Haematology 💻 Work Environment This is a remote contractor position supporting a customer project focused on AI-assisted clinical documentation. Previous AI experience is not required. The role is centered on applying your existing expertise in regulatory medical writing, clinical documentation, scientific accuracy, and clinical data interpretation. 💰 Compensation $30–$60 per hour 👥 30 openings available Compensation and project details are subject to the terms and requirements provided by micro1/customer. 👤 Who Should Apply? This opportunity may be relevant to experienced professionals working in: 💊 Pharmaceutical Medical Writing 📑 Regulatory Medical Writing 🧪 Clinical Documentation 📊 Clinical Study Reports 🛡️ Drug Safety Documentation 🏥 Clinical Research 🔬 Life Sciences 🧬 Oncology 🩸 Haematology CROs and Pharmaceutical Sponsors Applicants should carefully review the official job requirements before applying. 🚀 How to Apply Interested candidates can apply through micro1 using the application link below: Apply Now