Asst. Manager Medical Writing

Job Description: As a Medical-Regulatory Writer Assistant Manager, your main responsibility will be to plan and manage Medico-Regulatory Writing in accordance with relevant Regulatory Guidelines. You will be expected to deliver high-quality medical and scientific writing, provide technical consultation and advice on strategy and regulations, demonstrate subject matter expertise, effectively manage writing projects to meet deadlines, collaborate with internal and external clients, and produce various types of reports including CTD Modules, Safety Reports, and Aggregate Reports. Key Responsibilities: - 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 - Provide effective communication for operational excellence Qualifications Required: - Master's degree in Pharmacology/Pharmacy/Medicine with a minimum of 5 years of experience - Advanced degree preferred - Previous experience in the pharmaceutical/CRO industry - Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous,