Hybrid Medical Writer Job at GSK, Bengaluru
Ready to take your medical writing career to the next level with a global biopharma leader? If you have extensive experience in clinical regulatory writing and are passionate about transforming scientific data into impactful regulatory documents, this Hybrid Medical Writer Job at GSK Careers could be your ideal career move. GSK is hiring a Principal Medical Writer to lead the development of high-quality clinical and regulatory documents while collaborating with global cross-functional teams. This hybrid role offers the chance to contribute to innovative drug development programs and advance your career in medical writing.
About the Company:
GSK is a leading global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. The company aims to positively impact the health of 2.5 billion people by the end of the decade through the development of innovative vaccines and specialty medicines. GSK focuses on key therapeutic areas, including respiratory diseases, immunology and inflammation, oncology, HIV, and infectious diseases. The company promotes an inclusive culture that values innovation, collaboration, accountability, and continuous learning.
Position Summary:
The Principal Medical Writer independently leads the preparation of complex clinical and regulatory documents, ensuring high quality, scientific accuracy, and compliance with applicable standards and regulatory requirements.
Responsibilities:
- Lead development of key clinical and regulatory documents, including protocols, informed consent forms, clinical study reports, submission documents and regulatory responses.
- Interpret clinical and statistical data and present clear, accurate scientific messages in this Hybrid Medical Writer Job in Bengaluru.
- Collaborate with cross-functional matrix teams and manage writing assignments with minimal supervision while ensuring the documents meet GSK and global standards at GSK Careers.
- Support process improvement initiatives, and mentoring of junior writers.
Basic Qualification Required for the Hybrid Medical Writer Job:
- PhD or equivalent expertise with relevant experience; preferably at least 5 years of clinical regulatory writing experience in the pharmaceutical industry.
- Strong knowledge of regulatory writing, drug development, clinical research methodology, statistics, ICH-GCP.
- Excellent ability to interpret clinical data and communicate clearly in written and verbal English.
- Strong computer literacy and ability to use relevant document preparation and review tools.
Key Skills and Capabilities:
- Strong stakeholder management and cross-functional collaboration skills.
- Ability to lead document planning and development and review discussions.
- Proactive, quality-focused approach with commitment to continuous improvement.
Benefits of the Hybrid Medical Writer Job:
You will join a team that values respectful collaboration, continuous learning and accountability. You will gain exposure to global teams and complex clinical programs. You will have clear opportunities to broaden your technical skills and take on increasing responsibility.
