Salary: Open
Employment Type: Permanent
Languages: Japanese > Native, English > Business Level
Sub-industry: Biotechnology
Function: Healthcare R & D

Company Overview

デンマークに本社を持つ同社は癌の抗体医薬の開発に注力しており、日本でも既に3品目の臨床入りを果たす。
グローバルとの距離も近く、ビジネスの益々の拡大を図る。

Job Description

Overseeing and developing clinical projects including component studies

Providing not only strategic and scientific input but also development support for clinical plans and individual study protocols

Developing case report forms, performing medical monitoring, liaising with investigators and site personnel

Performing preliminary and exploratory data analyses clinical trials

Authoring clinical study reports; providing input on publication materials

Participating in the development of clinical operating guides, maintenance of secure study files and reviewing results of these evaluations with appropriate management prior to implementation

Lead and support regulatory submission documents such as briefing documents and relevant clinical modules in J-CTD

Participate and represent Japan at global Compound development Team and provide proactive scientific input related to Japan specific needs and/or requirements.

Collaborate cross-functionally with other R&D functions both at local and global level for clinical projects related to Japan development.

Requirements

Oncology experience
CTD & Protocol experience
Business level English

Additional Information


Probation Period: NA
Smoking Conditions: NA
Overtime: NA
Social Insurance: Available
Holidays: Available
Working Hours: 9:00 AM - 6:00 PM
Lunch Break: 12:00 PM - 1:00 PM
Benefits: 面接内の評価、並びに今までのご経験により応相談
Job reference: JO-210727-266328

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