Principal Medical Writer (FHI Clinical)
FHI CLINICAL INC.
Summary of the Position: The Principal Medical Writer is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. Complete medical/scientific writing assignments, as required for clinical projects undertaken by the Company. Take a leading role in preparing assigned documents, which includes but is not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews and communicating directly with the client on medical writing-related issues as they arise. Coordinate information and data inputs from team members when preparing trial documents. Independently plan and organize workload for assigned projects and tasks, identify project needs, track timelines and implement customer requests. Essential Functions: Write, or coordinate the writing of appropriate sections of: Protocols and protocol amendments. Clinical study reports, addenda and synopses. Collation of finalized clinical study reports. Investigator’s Brochures. Safety update reports. Publications. Statistical reports (provide assistance to the...
South Africa : Western Cape
2022-12-02
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