PMSオペレーションマネージャー/ PMS Operations Manager
給与 ¥7,000,000 - ¥10,000,000 per annum
担当コンサルタント Sarah Arshad
掲載日 2018/10/22 2018-10-222018-12-07 pharmaceuticals 3-12-18 Shibuya, Shibuya-ku Tokyo, 150-0002 Robert Walters
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.
- 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
- 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
About the Company:
One of the largest biotechnology and pharmaceutical group, this company utilizes its scientific to develop medicine and medical devices. This company also runs a successful educational outreach program giving university students research opportunities.
バイオ製薬, 製薬, 製薬業界, 医薬品, 生医学, ライフサイエンス, 生命科学, 医療, メディカル, ヘルスケア, 法務, 法律, コンプライアンス, リスク