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
