GSK
Pharmaceutical
PrincipalMedicalWriter
“Principal Medical Writer at GSK. Skills: Medical writing, Regulatory writing, Clinical documentation. Author clinical regulatory documents. Deliver clinical regulatory documents”
Industry & Context.
Interpret complex data; Identify key trends; Identify key messages
What They're Looking For.
Must Have
PhD or equivalent relevant experience, Advanced clinical regulatory medical writing experience, Independently author complex regulatory documents, Lead or contribute to CTD submission dossiers, Understanding of clinical trial design, Understanding of regulatory requirements, Understanding of statistical concepts, Understanding of clinical data interpretation, Proven leadership capability, Experience influencing and collaborating globally, Working knowledge of ICH guidelines, Working knowledge of Good Clinical Practice, Written English communication skills, Verbal English communication skills
What You'll Do.
Author clinical regulatory documents
Deliver clinical regulatory documents
Lead planning of clinical dossier documents
Contribute to clinical dossier documents
Deliver clinical dossier documents
Partner within cross-functional teams
Produce fit-for-purpose documents
Manage complex writing projects
Coordinate multiple contributors
Adapt plans to evolving priorities
Interpret complex clinical information
Interpret complex statistical information
Translate data into regulatory narratives
Review reporting plans
Review analysis plans
Provide input on tables
Provide input on data presentation
Apply efficient document development approaches
How You'll Work.
Team & Collaboration
Cross-functional, matrix teams; Global, multicultural, matrixed environments
Communication Scope
Written English; Verbal English
Process & Methodology
Manage complex writing projects
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