募集要項
- 仕事内容
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【Main Responsibilities】
- Both IVD and medical device MAH Quality responsible person (Hinseki).
- Both IVD and medical device MAH manufacturing manager (Seizou Sekininsha).
- Lead and support for collaborating with BU and SU stakeholders to manage quality issues including support for the administration of field actions (Recall) and reporting in complaint system.
- To update QMS documents based on local regulation modification/new release.
- To lead regular internal QMS meeting and management review meeting.
- To support all related company license (MAH IVD/medical device, poisonous substance import, medical device maintenance etc.)
- To support medical writing regarding both IVD and medical device STED.
- To support PMDA consultation document preparation and preparation for answers of queries from PMDA.
- 応募資格
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- 必須
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- Minimum of 7 years’ work experience in medical or life science market.
- Pharmaceutical license holder (Government certified Pharmacist License)
- Excellent cross functional communication skills.
- Strong business acumen in understanding commercial aspect of healthcare business.
- Organized individual with strong self and project management disciplines, including the ability to lead, facilitate, influence and organize across groups and according to timelines.
- Knowledge of MS Excel, Word, PowerPoint for business presentation and knowledge of PMDA DTD system will be highly advantageous.
- Business level of English
- <10% of Traveling
- Internal responsibilities: Operation, CS Department
- External responsibilities: LBS BU, Regulatory authority (MHLW, PMDA, JACRI etc.)
- 歓迎
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- >5 years People Management experience (Preferred)
- Effective communication skills in English and a client service orientation
- Teamwork, Self-starter, Integrity, Goal oriented
- 募集年齢(年齢制限理由)
- 長期的勤続によりキャリア形成を図るため (長期勤続によりキャリア形成を図るため)
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 900万円 ~ 1199万円