Senior Medical Writer

Role Overview: As a Senior Medical Writer at Bengaluru Luxor North Tower, you will work largely independently on assignments or for complex documents under the guidance of a mentor. Your role involves facilitating the delivery of written assignments through proactive coordination of stakeholders to build content. You are expected to have a strong understanding of clinical trials design and interpretation of statistically analyzed clinical research data. It is crucial for you to drive and coordinate the process to draft, review, and approve written assignments while meeting the quality standards of the global organization. Working in complex matrix organizations is an essential part of your responsibilities. Key Responsibilities: - Complete assignments independently or for more complex documents under the guidance of a mentor - Author a range of clinical documents, including regulatory documents following defined templates - Ensure high integrity of data interpretation and negotiate with the document team - Maintain consistency and quality level of all issued documents - Actively participate in planning, coordination, and review meetings - Ability to work on 2-3 assignments simultaneously - Proactively raise concerns/issues within the global team and promote high medical writing standards - Collaborate with different roles within GSK such as Clinical Leads, Asset Leads, and Biostatisticians - Establish a network of communication and build collaboration to facilitate smooth partnerships and interfaces Qualification Required: - PhD or equivalent expertise (e.g., a master's degree with a minimum of 2 years relevant experience) - Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry - Good understanding of basic drug development and scientific methodology - Knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP) - Necessary computer skills and general computer literacy - Excellent English language skills (verbal and written),