Description
The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. He/she has the ability to plan and prioritize without supervision. This role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.
Specifically for this position:
7+ years of advanced regulatory medical writing experience (protocol, CSRs, briefing books, summary modules), prior experience in oncology and understanding of clinical pharmacology concepts will be an advantage.
Proven expertise in completion of a multiple-document projects including functioning as the lead medic...
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