クリニカルオペレーションズジャパンメディカルライティング/メディカルライティング 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2018年 09月 19日

求人情報

メディカルライティング

求人管理No.008261

会社概要

クリニカルオペレーションズジャパンメディカルライティング

Plan, write, and manage clinical trial reports and contribute to other clinical documents essential for obtaining marketing approval worldwide. Provide critical input to the analysis and interpretation of clinical data.

募集要項

・Be responsible for clinical documents on study level or project level, as assigned. 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 trial teams.
・Quality and timeliness of clinical documents. Compliance of documents with international guidelines and corporate SOPs. Successful and efficient interaction with teams.
・Ensure quality of clinical documents (study-level, or project level as appropriate) assigned to external providers by appropriate oversight and training. Contribute to appropriate budget planning and cost control.
・Quality of CTRs and compliance with relevant SOPs. Stay within timeline and budget.
・Adhere to and improve medical writing standards.
・Knowledge of and compliance with CTR standards. Extent and quality of contribution.
・Contribute to the organizational development of Clinical Operations Japan as a member of the organization- participate in different initiatives within COJ as appropriate
・feedback of stakeholders

募集条件

  • <Required Skills>
    Special Skills
    Skills and Competencies Ability to effectively communicate complex clinical information in writing for the target audiences; capacity to structure text and data in a clear and concise fashion; ability to convey data patterns in text, tables, or graphs. 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. Project management skills including time management; ability to manage projects effectively across regions; strong interpersonal and social skills; ability to communicate effectively in international cross-functional teams; diplomacy; cultural and political sensitivity; presentation skills; ability to achieve results in complex matrix environments; proficiency in word

    <Special Work Experience>
    Leadership experience (1-3 years leading projects) and international experience (international exposure in daily business> 3 years or worked abroad > 1.5 years).

    <Language Skills & Proficiency>
    Japanese:Native/Fluent(Read・Wright・Speak)
    English:Native/Fluent(Read・Wright・Speak)

    <Required education>
    Degree / education:Bacheloes Degree 学部卒
    Or Masters Degree eg MBA or MSc 博士修了
    Or Doctoral Degree eg. PhD or MD 博士修了
    Major, focus:Medicine 薬学、Life Science

勤務開始日

  • 応相談

採用人数

  • 1

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • なし

給与

  • 年齢経験により応相談