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Johnson & Johnson キャリア

【Medical】 CMO Office, Clinical Lead (Manager)

千代田区, 日本
Clinical Research non-MD


仕事内容

Requisition ID: 1905767355W

[概要]

This position is accountable for all scientific discussion/deliverables, especially in case of the necessity of some clinical data, study design and outlines, study results and clinical data package in clinical studies (included company initiated studies (CIS) and Post Marketing Surveillance (PMS)) in the assigned projects, from early to post-marketing. This position is responsible to discuss the clinical data package and/or the necessity of clinical data, to execute designing, implementation and completion of clinical studies fulfilling clinical data package for appropriate submission and also to execute appropriate communication with Pharmaceuticals and Medical Devices Agency (PMDA) about clinical studies; e.g. PMDA consultation, submission, etc

 

And accountable to ensure input and support in the development of Evidence Generation strategy as representative from Clinical Research.

 
[具体的な業務例]
  1. Responsible for team’s interface and collaboration with Key Opinion Leaders(KOLs) and management.
 
  1. Lead clinical scientific discussions with PMDA, including proposed clinical investigations.
 
  1. Lead the confirmation for clinical data, study results, and essential documents for the clinical data package, and lead the regulatory inspection by PMDA
 
  1. Develop, revise and maintain study design and outlines, scientific rationale, Protocol Synopsis and full protocol of the local clinical studies/CIS/PMS.
 
  1. Lead to implement study protocol including knowledge transfer to clinical operation team, execution of clinical study oversight of clinical studies/CIS/PMS in Japan, and also to prepare for the following documents as applicable: Investigator’s Brochure (IB) – Japanese translated version
Case Report Form (CRF)

FAQ on patient eligibility or other medical issues and potential concerns

Major protocol deviation criteria, if any
Safety management plan, if any
Statistical Analysis Plan (SAP)
Analytical risk based monitoring plan

Related other documents to clinical studies

Training materials for clinical operation team involved and investigators

 
  1. Lead to execute medical monitoring while conducting independent clinical study in Japan (Local study).
 
  1. Lead to develop Clinical Study Report (CSR) of the Local study, relevant parts of Summary of Technical Documents (STED), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
 
  1. Lead to develop annual report of PMS and report to Health Authority
 
  1. Lead to develop publication plan with collaborative relationships with Medical Affairs.
 
  1. Lead to file relevant parts of STED as JNDA including labeling discussion.
 
  1. Contribute to package insert (J-labelling) development.
 
  1. Develop and maintain working relationships with others requiring interaction and mutual support
 
  1. Contribute the development and deliver appropriate Evidence Generation strategy to support New Product Development and Life Cycle management with collaborative relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs. HEMA, etc).


資格
<職務経験>
・医薬品・医療機器の臨床開発経験を8年以上有する
・クリニカルオペレーションのみのご経験である場合、治験実施責任者等のポジションで試験全体を俯瞰するご経験があることが望ましい
 
<必要とする能力・スキル>
・GCP及び薬事・薬機法等関連法規
・コミュニケーションスキル
・英語(reading、writing、speaking、TOEIC800以上、若しくは同等)

・日本語(reading、writing、speaking、Native Speaker level)

・パソコン操作(Word、Excel、PowerPointなど)
 
<資格/免許>
・医学、薬学、生物学系大学 学部卒業以上
 
<求める人物像>
円滑な業務遂行のため、社内外の関係者と良好な関係を構築する意識とコミュニケーション力を持っている人。
業務の成果達成に対して責任を持ち、常に前向きに取り組める人。


プライマリ場所
日本-東京都-千代田区-
組織
Johnson & Johnson K.K. (8235)
ジョブ
Clinical Research non-MD
Requisition ID
1905767355W