Asst. Manager Medical Writing

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specifications, attend project meetings, stay updated on regulatory guidance, maintain Aggregate Report Tracker, perform detailed searches on regulatory agency websites, mentor associates, and provide effective communication that leads to operational excellence. To qualify for this role, you should have a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience. An advanced degree is preferred, along with previous experience in the pharmaceutical/CRO industry. Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous. You should possess excellent data interpretation and medical writing skills, strong project management abilities, interpersonal and negotiation skills, and exceptional oral and written communication skills. Knowledge of global, regional, and national document development guidelines, along with proficiency in Microsoft Word, PowerPoint, and Excel, is essential. You should be able to work well in a team, handle pressure, and deliver quality work within tight timelines. Occasionally, you may need to work in different time zones. This position does not have any direct reports and is based in Gurgaon. If you meet the qualifications and possess the required skills and abilities, we invite you to apply for this challenging and rewarding role in the medical-regulatory writing field.,