メディカルライティング | Japan

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

Apply Now

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!

Be updated, Subscribe to Raketera
For more job vacancies visit Hiring UAE | Hiring Dubai | Hiring Pinas | UAE Careers | Job Mega