医薬開発本部クリニカルディベロップメント＆オペレーションズジャパンメディカルライティング

職種

• 医薬品メディカルライター

仕事内容

Basic purpose of the job Independently writes and manages clinical documents, such as clinical trial reports, Investigation Brochures, Protocols and briefing documents, in both local and global cross-functional project- and study teams, as well as local clinical regulatory documents for submission to the Japanese Health Authority (HA) and other documents related to HA interaction. Provide critical input to the analysis and interpretation of clinical data in the assigned writing projects. Accountabilities Responsible for the preparation of clinical documents on study- and project-level required for advancing clinical development programs. This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines. Contribute to scientific and regulatory discussions within the study and project teams. Requires proactive and continuous cross-functional coordination to ensure timely and successful document finalisation.

求める能力・経験

Minimum Bachelor degree in Pharmacy, Medicine or Life Science. Advanced degree in Pharmacy, Medicine or Life Science preferred. Skills and Competencies: Ability to independently and effectively communicate complex clinical information in writing for the target audiences; scientific and analytical thinking; understanding of medical concepts, statistics, pharmacokinetics, and pharmacodynamics; ability to comprehend and interpret clinical data; understanding of the clinical development process and relevant global and local regulatory guidelines.

雇用形態

給与

700万円〜1,200万円

勤務時間

休日・休暇

社会保険

備考

配属先

転勤

住所

東京都品川区

制度

その他

制度備考