Site Name:
Bengaluru Luxor North Tower
Posted Date:
Nov 28 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 Associate Director, Safety Writing, is responsible for leading the safety writing team and ensuring accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans (RMP). They will provide essential oversight and input into all aspects of aggregate reports and RMP preparation. They will participate in process improvements and foster an environment for idea generation.Key Responsibilities (suggested no more than 10 bullet points)
- Manage a team of 8-10 in-house medical writers to develop aggregate reports and RMPs in scope to support delivery of the portfolio. Identify needs for development and for team members to expand their competence and capability in generating documents and working effectively with colleagues in the central teams. Set annual objectives to meet writers capabilities, development potential and business needs (People Management/Development).
- Ensure medical writers are trained in relevant procedures, policies and standards to be applied for safety writing activities. Lead development of training materials for safety documents, and provide mentoring, coaching and/or training to individuals or teams. Promote best writing practices and build capability (ICH, GCP/GVP standards, process development, application and alignment).
- Evaluate resources required for safety writing activities to ensure alignment with the organizations strategic and operational objectives (Setting priorities and resource management). Provide project updates to leadership and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements.
- Interface with the cross-functional safety teams, and third parties, as required, to ensure appropriate input and alignment with stakeholders for the resourcing and generation of safety reports in scope (On-time delivery with quality).
- Drive and implement key organizational process improvement initiatives. Proactively generate ideas for improvement and promote an empowering environment for others to generate ideas (e.g., for accelerated, simplified processes); champion improvements in technology and ways of working.
- Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall project performance.
- In collaboration with the MW leadership team and the Safety leadership team, measure and monitor efficiency and quality of the team's output, collect and evaluate metrics to identify the need for improvement in processes, staff educational activities, etc.
Education Requirements (minimum expected)Minimum qualification required would be a master's degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in a hospital-based environment, would be an advantage.
Job Related Experience (minimum Requirements)
6-8 years experience in safety writing, including leading the development of safety reports in a post-market setting within the pharmaceutical/ Contract Research Organization industry.
