About this role
At GSK, the Senior Medical Writer supports bold ambitions to positively impact the health of 2.5 billion people by the end of the decade. The role focuses on R&D efforts that combine understanding of the immune system with cutting-edge technology to deliver vaccines and medicines. Writers operate within a culture that is ambitious for patients and accountable for impact.
The Senior Medical Writer authors clinical regulatory documents following defined templates, including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, and briefing documents. They interpret statistically analysed clinical research data and ensure high integrity of data presentation through negotiation with document teams. Multiple assignments are managed simultaneously while meeting global quality standards.
Work occurs in complex matrix organizations, requiring direct collaboration with Clinical Leads, Asset Leads, Study Delivery Leads, Biostatisticians, and other Medical Writers. The writer actively participates in planning, coordination, and review meetings while building networks that facilitate smooth partnerships across global teams.
This position offers the opportunity to drive document processes from draft through approval and to promote high medical writing standards by raising concerns and proposing alternatives. Writers contribute to accelerating significant assets that meet patient needs and have the highest probability of success.
Requirements
- Up to 5 years clinical regulatory writing experience in the pharmaceutical industry
- At least 4 years of clinical or safety medical writing experience in the pharmaceutical industry
- Proven experience preparing clinical or safety documents such as clinical study reports
- Good understanding of basic drug development
- Understands clinical trials design and interpretation of statistically analysed clinical research data
Responsibilities
- Complete assignments independently or for complex documents under guidance of a mentor
- Author clinical regulatory documents including protocols, clinical study reports, NDA/MAA CTD submissions, investigator brochures, and briefing documents
- Ensure high integrity of data interpretation following negotiation with the document team
- Ensure consistency and quality level of all documents issued
- Actively participate in planning, coordination, and review meetings
- Work on 2-3 assignments simultaneously while meeting global quality standards
- Proactively raise and discuss concerns in an open and timely manner to promote high medical writing standards
- Establish networks of communication and build collaboration across groups involved in delivery of writing assignments
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