Senior Medical Writer

Role & Responsibilities
• Prepare and review clinical study outlines, feasibility synopses, and clinical trial protocols (Phase I–IV, BA/BE)
• Author and review Clinical Study Reports (CSRs) for regulatory submissions
• Prepare Common Technical Documents (CTDs) and subject-facing documents (ICD, IBs, diaries, etc.)
• Draft and review SAE narratives and regulatory submission documents (IND, NDA, BLA, MAA, 505(b)(2), biosimilar, hybrid applications)
• Develop Module 2.4, 2.5, 2.6, 2.7 summaries, Clinical/Non-clinical Overviews, ISS/ISE, and briefing documents
• Draft Pre-IND, Pre-NDA, SAM, orphan drug designation and expedited approval packages
• Support cross-functional teams with SAPs, TLFs, eCRF outlines and study-specific documentation
• Manage medical writing activities across studies and departments with minimal supervision
• Ensure compliance with internal SOPs and global regulatory guidelines
• Prepare and maintain departmental SOPs and quality documentation
• Collaborate with Biostatistics, Data Management, Regulatory Affairs, and Medical Leads
• Manage departmental administrative requirements and additional tasks as assigned

Qualification
PhD / MBBS / MD / M.Pharm / Pharm.D

Experience
Minimum 5 years of professional regulatory medical writing experience

Skills
• Expert knowledge of regulatory guidelines and submission requirements
• Strong proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat/PDF editors
• Understanding of publication processes and congress activities
• Excellent interpersonal and communication skills
• High attention to detail and scientific writing excellence
• Strong multitasking, prioritization, and teamwork abilities

About the Company
A growing clinical research organization delivering high-quality regulatory medical writing, clinical documentation, and submission support services to global pharmaceutical and biotechnology clients