Senior Regulatory Medical Writer Clinical trials

Roles & Responsibilities
• Act as regulatory lead on assigned projects and collaborate with cross-functional teams (Clinical, Data Management, Biostatistics, Operations)
• Prepare Clinical Study Reports (CSRs), clinical summaries, protocol summaries, and regulatory responses
• Interpret and understand clinical trial protocols, study design, data analysis, timelines, and patient recruitment
• Coordinate document review, approvals, QC, and submission activities
• Arrange and lead internal and external document review meetings
• Independently resolve content and scientific issues during document development
• Develop scientific publications including manuscripts, abstracts, posters, and oral presentations
• Provide project and timeline management support for ongoing programs
• Ensure timely delivery of regulatory submissions and updates to leadership
• Communicate progress, milestones, risks, and resource needs to management
• Ensure compliance with ICH, CDSCO, and applicable regulatory guidelines and SOPs
• Identify and implement process improvements
• Mentor junior writers and oversee internal teams or external vendors

Qualification
• Bachelor’s degree in Life Sciences with significant writing experience
• Advanced degree (MS Pharmacy / PharmD / PhD / MD) preferred
• Certification in Regulatory Affairs and/or Medical Writing preferred

Experience
• 2–4 years of industry experience in regulatory or medical writing
• Experience in healthcare, CROs, academia, or related areas such as clinical research, regulatory, quality, or R&D

Skills
• Strong knowledge of clinical development processes and ICH-GCP guidelines
• Expertise in regulatory and clinical document writing
• Working knowledge of statistical concepts and data interpretation
• Excellent written and verbal communication skills
• High attention to detail with strong editing and peer-review abilities
• Experience with CTD templates and electronic document management systems
• Proficiency in MS Word, PowerPoint, Excel, and Adobe Illustrator
• Strong project management, coordination, and mentoring skills

About the Organization
Jeevan Scientific Technology Limited is a global life sciences services company delivering integrated solutions across clinical research, regulatory affairs, pharmacovigilance, and medical writing, supporting pharmaceutical and biotech organizations throughout the product lifecycle.