Principal Medical Writer

Site Name:

Bengaluru Luxor North Tower, Mississauga Milverton Drive

Posted Date:

Dec 19 2025

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.Find out more:Our approach to R&D

Job Purpose :

The Medical Writing Manager is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analysed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement. He/she has the ability to plan and prioritize without supervision.

Key Responsibilities:

Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.

• Proven track record in writing a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, Informed consent forms (ICF), clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents (BD), and responses to regulatory authority questions.
• Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Demonstrated effectiveness in management of projects of increasing scope and complexity.
• Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
• Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
• High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
• Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
• Review reporting and analysis plans and provides critical input on the content and display of tables.
• Familiarity with approaches to expedite document preparation such as review tools and automation.
• Can mentor junior writers
• Demonstrated ability and willingness to adjust behaviours and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
• Effectiveness in both oral and written communications. And invite you to tell us
  

Knowledge/Education Required :

PhD or equivalent expertise (e.g., a master's degree with relevant experience)Life sciences PhD is the minimum post graduate entry qualification required for this grade. The role will require a good understanding of complex regulatory writing processes including data interpretation & skills to communicate information to target audiences. The post graduate qualification should reflect experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience.