Job Position: メディカルライティング
Job Description: Tokyo – 外資製薬メーカー 業務内容 ■概要 – Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for filing regulatory dossiers in Japan as planned by the R＆D Development Teams. – Establish cooperative partnership with other functions within BMKK and GRD to maintain fully integrated and standardized processes and systems. – Fulfill the role of Japan Documentation Lead. ■役割 – A senior level scientific writer who creates basic clinical/regulatory documents (e.g. CTD M2.7.6)， complex clinical/regulatory documents (e.g. CTD M2.7.3/2.7.4， CSR) and high level clinical/regulatory documents (e.g. CTD M2.5， responses to Health Authority) independently， ensuring the coordination and integration of the scientific， medical， and regulatory input from development team members. – Coordinate translation of IBs to Japanese. – Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for clinical/regulatory docu…see more details
Note: This advertisement for メディカルライティング maybe valid for one month from the date it was posted, so don’t miss the chance and apply now!
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