Senior Medical Writer

As a Senior Medical Writer at MS Clinical Research Pvt Ltd, you will be responsible for creating high-quality, scientifically accurate medical documents to support clinical trial activities and regulatory submissions. Your role will involve preparing and reviewing clinical study protocols, reports, and other trial documents in compliance with regulatory guidelines and industry standards. Additionally, you will collaborate with cross-functional teams, interpret clinical trial data, assist in regulatory submissions, and contribute to project planning and timelines. Key Responsibilities: - Prepare and review clinical study protocols, reports, and other trial documents following regulatory guidelines. - Collaborate with cross-functional teams to ensure accuracy and completeness of medical writing deliverables. - Interpret and summarize clinical trial data from various sources. - Assist in preparing regulatory submissions such as INDs, NDAs, BLAs, and MAAs. - Participate in project meetings, provide updates on writing activities, and contribute to project planning. - Stay updated with developments in medical writing, regulatory requirements, and relevant therapeutic areas. - Mentor junior medical writers and provide guidance on best practices. Qualifications: - Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred. - Minimum of 5 years of experience in medical writing within pharmaceutical, biotechnology, or CRO industry. - Proficiency in interpreting and summarizing clinical trial data, including statistical analyses. - Strong understanding of regulatory guidelines (ICH, FDA, EMA) for clinical trial document preparation. - Excellent written and verbal communication skills for clear scientific communication. - Detail-oriented with exceptional organizational and time management skills. - Ability to work independently and collaboratively in a team environment. - Proficiency in Microsoft Office Suite and document management systems (e.g., SharePoint). MS Clinical offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development and advancement.,