Roles & Responsibilities:
• Prepare and review clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and other clinical trial documents in line with regulatory guidelines and industry standards
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure accuracy and completeness of deliverables
• Interpret and summarize clinical trial data from study reports, statistical analyses, and scientific literature
• Assist in preparation of regulatory submissions (INDs, NDAs, BLAs, MAAs) with high-quality medical writing support
• Participate in project meetings, provide updates on medical writing activities, and contribute to project planning and timelines
• Stay current with developments in medical writing, regulatory requirements, and therapeutic areas relevant to projects
• Mentor junior medical writers and provide guidance on best practices for document preparation
Qualifications:
• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree (MD, PhD, PharmD) preferred
Experience:
• Minimum 5 years of experience in medical writing within pharmaceutical, biotechnology, or CRO industry
• Proficiency in interpreting clinical trial data, including statistical analyses and safety reports
• Strong understanding of regulatory guidelines (ICH, FDA, EMA) for clinical trial documents and submissions
Skills:
• Excellent written and verbal communication skills
• Detail-oriented with strong organizational and time management abilities
• Ability to work independently and collaboratively in multidisciplinary teams
• Proficiency in Microsoft Office Suite and familiarity with document management systems (e.g., SharePoint)
About the Organization:
MS Clinical Research Pvt Ltd is a dynamic and innovative clinical research organization specializing in clinical trials and comprehensive medical writing services. The company is committed to advancing medical research, supporting regulatory submissions, and improving patient outcomes through high-quality, scientifically accurate documentation and collaborative project execution.
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