■ Creation of clinical study protocols ■ Creation of clinical study reports ■ Preparation of pharmaceutical approval application documents (CTD: Common Technical Document) (non-clinical or clinical part) ■ Preparation of investigational drug summaries ■ Review of the above-created documents ■ Regulatory correspondence (document creation, review, or consulting for clinical parts, etc.) ■ General consulting for document creation that meets regulatory requirements ■ Appropriate guidance for less experienced members and contribution to members' growth * For Principal Medical Writer/Senior Medical Writer positions, leading the Medical Writing part of the project team is also expected.
The above information is a public job ad. This job ad is neither an offer nor a contract.
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