About the job Job Title Medical Writer Company MS Clinical Research Pvt Ltd Location Indiranagar Bangalore Job Type Full-time Experience 2-4 years About MS Clinical MS Clinical is a dynamic and creative company dedicated to advancing medical research and improving patient outcomes We specialize in conducting clinical trials and providing comprehensive medical writing services to pharmaceutical biotechnology and healthcare organizations worldwide We are seeking an experienced Medical Writer to join our vibrant team The successful candidate will be responsible for creating high-quality scientifically accurate medical documents in support of our clinical trial activities and regulatory submissions The ideal candidate will have a strong background in medical writing excellent communication skills and the ability to work both independently and collaboratively in a fast-paced environment ResponsibilitiesPrepare and review clinical study protocols clinical study reports CSRs investigator brochures IBs and other clinical trial documents in accordance with regulatory guidelines and industry standards Collaborate with cross-functional teams including clinical operations regulatory affairs and biostatistics to ensure the accuracy and completeness of medical writing deliverables Interpret and summarize clinical trial data from various sources including study reports statistical analyses and scientific literature Assist in the preparation of regulatory submissions including INDs NDAs BLAs and MAAs by providing high-quality medical writing support Participate in project meetings provide updates on the status of medical writing activities and contribute to project planning and timelines Stay current with developments in the field of medical writing regulatory requirements and therapeutic areas relevant to our projects Mentor junior medical writers and provide guidance on best practices for medical writing and document preparation QualificationsBachelor s degree in life sciences pharmacy or related field advanced degree e g MD PhD PharmD preferred Minimum of 3 years of experience in medical writing within the pharmaceutical biotechnology or contract research organization CRO industry Proficiency in interpreting and summarizing clinical trial data including statistical analyses and safety reports Strong understanding of regulatory guidelines e g ICH FDA EMA governing the preparation of clinical trial documents and regulatory submissions Excellent written and verbal communication skills with the ability to communicate complex scientific concepts clearly and effectively Detail-oriented with exceptional organizational and time management skills Ability to work independently and collaboratively in a multidisciplinary team environment Proficiency in Microsoft Office Suite and familiarity with document management systems e g SharePoint Benefits MS Clinical offers a competitive salary and benefits package including health insurance retirement plans and opportunities for professional development and advancement
📌 Medical Writer (Karnataka)
🏢 MS Clinical
📍 Karnataka
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