募集要項
- 募集背景
- A large biotechnology and pharmaceutical group is looking for a candidate with pharmaceutical background for the role of PMS Operations Manager. In this position, you will enforce compliance with internal and local regulations and standardizing the PMS operational processes.
- 仕事内容
-
A large biotechnology and pharmaceutical group is looking for a candidate with pharmaceutical background for the role of PMS Operations Manager.Responsibilities:
* Create and maintain business procedure documents, including SOPs and work instructions, pertaining to the operational aspects of PMS activities
* Develop standard templates for protocols and forms, data management plans and statistical analysis plans for PMS activities in line with Japanese conventions
* Execute data management and statistical analysis and report results of such activities, in collaboration with PMS Project Leads.
* Monitor progress of PMS activities, internal functions and external parties, including business partners
* Prepare reports for regulatory submission
* Enforce operational compliance with internal business procedures and local regulations, including compliance related to interactions with medical institutions and healthcare professionals
Requirements:
* Bachelor's degree in Pharmacy, Medicine or a related discipline in addition to 7+ years' relevant work experience or Master's degree in Pharmacy, Medicine or a related discipline in addition to 5+ years' of relevant work experience
* Competency in Microsoft Office Outlook, Word, Excel, PowerPoint and Project
* Advanced verbal and written proficiency in English
* Skills in project management
* Knowledge of data management, statistical analysis, GPSP, GVP and GCP
- 応募資格
-
- 必須
- Knowledge of data management, statistical analysis, GPSP, GVP and GCP
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY7,000,000.00 - JPY10,000,000.00 per annum
