Clinical Scientist - 製薬会社

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お問合せ Eureka Teramura
参照 JO-1910-427260
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Note: Applicants must have permission to work in Japan and Fluent ~ Native level Japanese

[事業内容・会社の特徴]
外資系製薬会社

[仕事内容]
Major Responsibilities:
Compound life cycle management:

  • Executes R&D KOL management.
  • Execute R&D publications based on the agreed R&D publication plan.

Development planning and execution:

  • Supports to create revise and maintain study design and outlines, scientific rationale, Protocol Element Document (PED) and full protocol of the clinical studies aligned with the clinical study plan.
  • Provides leadership to implement study protocol including knowledge transfer to JCOL, execution of clinical study oversight of clinical studies in Japan, in addition to supporting to create and update the following documents:
  • Investigator's Brochure (IB) - Japanese translated version.
  • Case Report Form (CRF)
  • FAQ on patient eligibility or other medical issues and potential concerns during execution of clinical study in Japan.
  • Summary of the compensation system for subject health injury in Japan.
  • Major protocol deviation criteria, if any.
  • Medical monitoring plan/medical review plan, if any.
  • Statistical Analysis Plan (SAP).
  • Analytical risk based monitoring plan.
  • Related other documents to clinical studies.
  • Training materials for JCOL and study operation team involved.
  • Provides leadership to execute medical monitoring of the Local study, including handling medical inquiries (secondary response) from JCOL, the study operation team or investigators, etc.
  • Provides leadership to execute risk and feasibility assessment of full protocol of the studies including impact assessment of unapproved in Japan, out of scope in J-labelling, imported drugs regardless approval in Japan.
  • Supports to create Clinical Study Report (CSR) of the Local study, relevant parts of Common Technical Document (J-CTD), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
  • Supports to file CTD as JNDA including labeling discussion.

Post marketing activities:

  • Supports to package insert (J-labelling) development.
  • Supports to develop risk management plan including post marketing surveillance studies led by JSS.
  • If post marketing clinical study in Japan is considered, practical support will be necessary.

[応募資格]

  • BS degree
  • Pharmaceutical experience
  • Experience in clinical development
  • Ability to communicate in English
  • Flexiblity

[雇用形態]
正社員

[勤務地]
東京

[給与]
600万円〜1300万円
(能力・経験を考慮し当社規定により決定します。)

[休日休暇]
完全週休2日制、夏季・年末年始休暇、年次有給休暇

[選考プロセス]
書類選考、面接数回を予定

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