The Clinical Documentation and Process Specialist works in partnership with Clinical Development study teams to maintain the eTMF and other clinical systems, optimize processes, track compliance and training activities, develop and report KPIs/metrics, and ensure audit readiness, reporting to the Vice President, Clinical Development.
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USD/year
USD/year
The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents that support the company's objectives. The writer independently writes most clinical and regulatory documents within their remit and works closely with teams on document authoring and content strategies to ensure alignment with project goals. The writer contributes to project management strategies driving toward submission objectives.