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Principal Medical Writer

Virtual Vocations Inc

To support clinical-stage programs, the full-time Principal Medical Writer will independently author and oversee the development of high-quality submission-ready documents while collaborating with cross-functional stakeholders in a remote environment. Key Responsibilities Plan, author, and deliver submission-ready documents including protocols, INDs, and briefing documents Lead cross-departmental document development by collaborating with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams Establish and refine medical writing processes and manage efficient document workflows and timelines Required Qualifications Bachelor's degree in a life science or health-related field required; advanced degree preferred Minimum 10 years of relevant medical writing experience with demonstrated experience in IND submissions Strong understanding of FDA/EMA regulations and ICH guidelines Highly skilled in Microsoft Office suite, particularly MS Word, with experience in electronic document management systems preferred Ability to thrive in a fast-paced environment and collaborate effectively across teams Virtual Vocations Inc

Vacancy posted 2 days ago
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