The cleaned title is Assistant Manager Medical Writing

The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the delivery of quality products within agreed timelines. Collaboration with internal and external clients will be essential, along with tasks such as writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports, and other relevant documents. You will also be responsible for conducting science reviews of aggregate reports produced by PV Associates and ensuring that all document outputs and processes align with client specifications, templates, and style guidelines. Furthermore, the role requires attending project initiation meetings, maintaining awareness of current regulatory guidance and medical information techniques, updating Aggregate Report Tracker, carrying out cases reconciliation periodically, and conducting detailed searches on regulatory agency websites for safety alerts. Mentoring Associates, overseeing training plans, and enhancing the skills of existing team members will also be part of your responsibilities. The ideal candidate should hold a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience, although an advanced degree is preferred. Previous experience in the pharmaceutical/CRO industry is advantageous, along with additional qualifications in medical writing such as AMWA, EMWA, or RAC. Strong data interpretation, medical writing, and project management skills are essential, as well as excellent interpersonal, negotiation, oral and written communication skills. Proficiency in Microsoft Word, PowerPoint, and Excel, as well as the ability to work effectively in a team-oriented environment, are also required. This position may occasionally require working in different time zones as needed. There are no direct reports for this role, and the location will be in Gurgaon.,