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メディカルコンプライアンスオフィサー

年収:800万 ~ 1500万

ヘッドハンター案件

部署・役職名 メディカルコンプライアンスオフィサー
職種
業種
勤務地
仕事内容 Accountabilities for company compliance management
• To be familiar with the rules in the pharmaceutical industry and advises all departments in business from the viewpoint of legal affairs and compliance.
• Bridging the Global SOP and regional rules to create and update the appropriate SOP for them.
• Catching trends in rule changes at authorities and industry groups promptly and reflect them in the internal SOP.
• Audit and supervise information provision activities for internal and external stakeholders.
• Participate in the in-house approval flow and examine each project from the viewpoint of
compliance.
• Create a violation prevention program by actively verifying in-house compliance violations.
Perform regular verification, report to management and prevent recurrence by the program.
• Conduct regular compliance training for internal companies and partner companies in collaboration with the internal training department.
• Requesting advice from external advisors for maintaining appropriate compliance within the company.
Medical information management
• Create or review materials appropriate for information provision activities, based on the product material creation rules instructed by Japanese authorities and HQ.
• Be familiar with the information about company product and provide scientific advice to external and internal stakeholders.
• Verify scientific evidence from in-house materials and articles. Reflect appropriate information on sales and medical materials.
• Support Field Medical activities by providing appropriate information for medical activities based on the latest evidence and guidelines announced at academia and societies.
• Support for publication of papers written in-house or by the Investigator.
• Properly provide information according to information required from external stakeholders (Q
& A at call center and reception of external complaints regarding information provision activities and their response).
応募資格

【歓迎(WANT)】

Over 3yrs experience in the pharmaceutical compliance field •

• Familiar with legal rules in the pharmaceutical industry, code of practice, and MHLW guideline for activities of information provision
• Tertiary health/science related qualification
• Outstanding communication, writing, and presentation skills
• Ability to learn and effectively convey clinical and non-clinical information and international
scientific/medical publications information in Japan
• Ability to work in teams and autonomously.
• Strong business acumen


更新日 2021/03/09
求人番号 1679663

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