Completes assignments independently or for more complex documents, under guidance of a mentor
Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Ensures high integrity of data interpretation, following negotiation with document team
Ensures the consistency and quality level of all documents that are issued
Actively participates in all planning, coordination and review meetings
Ability to work on 2-3 assignments simultaneously
Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives
Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers)
Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments

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 (for example, clinical study reports)
Possesses a good understanding of basic drug development
Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
Demonstrates understanding of how to interpret, describe and document clinical data
Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)
Possesses necessary computer skills and general computer literacy
Excellent English language skills (verbal and written)

Senior Medical Writer

Key skills