Job Description We are seeking experienced Medical Writers (Regulatory & Clinical) to support U.S.-based biotech and pharmaceutical clients . This is a remote opportunity involving the preparation of regulatory and clinical trial documentation for global development programs. You will work on high-impact deliverables supporting IND, NDA, BLA, and EU submissions , collaborating with cross-functional clinical, regulatory, and biometrics teams. This role is ideal for candidates with strong scientific writing skills and direct experience in clinical research and regulatory documentation . Key Responsibilities Author and review clinical trial protocols, IBs, and ICFs Prepare Clinical Study Reports (CSRs) Draft ISS/ISE sections and regulatory summaries Support FDA and EMA submission modules (CTD format) Write safety narratives and clinical summaries Ensure documents comply with ICH, GCP, FDA, and EMA guidelines Collaborate with biostatistics, data management, and clinical teams Manage timelines and deliverables across multiple projects Required Qualifications Master’s or PhD in Life Sciences, Pharmacy, Medicine, or related field 3+ years of experience in regulatory or clinical medical writing Hands-on experience with CSRs, protocols, and regulatory submissions Strong understanding of ICH, GCP, FDA, EMA guidelines Excellent written English and attention to detail Ability to work independently in a remote environment Preferred Experience Oncology, rare disease, or specialty therapeutics Experience supporting IND/NDA/BLA submissions CRO or global pharma/biotech experience Familiarity with document management systems (Veeva, Vault, etc.) Work Model 100% Remote Based in India Long-term engagement for strong performers Exposure to U.S. and EU regulatory programs Compensation Competitive compensation based on experience Paid monthly Growth opportunities into Senior or Lead Medical Writer roles How to Apply Please email your résumé to: [email protected] Job Types: Full-time, Contractual / Temporary Pay: ₹12,785.51 - ₹41,483.54 per month Work Location: Remote
Job Description We are seeking experienced Medical Writers (Regulatory & Clinical) to support U.S.-based biotech and pharmaceutical clients . This is a remote opportunity involving the preparation of regulatory and clinical trial documentation for global development programs. You will work on high-impact deliverables supporting IND, NDA, BLA, and EU submissions , collaborating with cross-functional clinical, regulatory, and biometrics teams. This role is ideal for candidates with strong scientific writing skills and direct experience in clinical research and regulatory documentation . Key Responsibilities Author and review clinical trial protocols, IBs, and ICFs Prepare Clinical Study Reports (CSRs) Draft ISS/ISE sections and regulatory summaries Support FDA and EMA submission modules (CTD format) Write safety narratives and clinical summaries Ensure documents comply with ICH, GCP, FDA, and EMA guidelines Collaborate with biostatistics, data management, and clinical teams Manage timelines and deliverables across multiple projects Required Qualifications Master’s or PhD in Life Sciences, Pharmacy, Medicine, or related field 3+ years of experience in regulatory or clinical medical writing Hands-on experience with CSRs, protocols, and regulatory submissions Strong understanding of ICH, GCP, FDA, EMA guidelines Excellent written English and attention to detail Ability to work independently in a remote environment Preferred Experience Oncology, rare disease, or specialty therapeutics Experience supporting IND/NDA/BLA submissions CRO or global pharma/biotech experience Familiarity with document management systems (Veeva, Vault, etc.) Work Model 100% Remote Based in India Long-term engagement for strong performers Exposure to U.S. and EU regulatory programs Compensation Competitive compensation based on experience Paid monthly Growth opportunities into Senior or Lead Medical Writer roles How to Apply Please email your résumé to: Farhan@NaseejConsulting.com Job Types: Full-time, Contractual / Temporary Pay: ₹12,785.51 - ₹41,483.54 per month Work Location: Remote