●内科医や技師等顧客先における、導入時およびフォローアップトレーニングを実施する。 ●アンギオグラフィー装置、放射線医学装置及び放射線造影装置、透視台など、AXビジネスモダリティグループ（AXBMG）の担当製品全て及びDynaCT・ICD3等新製品についてのアプリケーショントレーニングを実施する。 ●システム操作に関する顧客満足の向上とシーメンス製の機器に関する深い理解 ●営業・サービス部門及びAXBMGメンバーに対して、顧客満足の状況およびシステム性能に関する正確なフィードバックを行う。 【職務範囲】 ●顧客（内科医および技師等）に対するAX関連装置の導入トレーニングの実施 ●フォローアップトレーニングの実施 ●学術会議の準備及びデモンストレーションに関する顧客サポート ●画像データ、三次元ワークステーション画像、ワークフロー図等のマーケティング資料作成 ●マニュアルの翻訳チェック、作成 【担当製品】アンギオグラフィー装置（心血管造影、脳血管造影、抹消血管造影）、放射線医学装置（透視台など）、および放射線造影装置 【組織】AXアプリケーションスペシャリストチーム（4～5名体制）の一員として、アプリケーションマネージャー、AXチームリーダーの下で業務を行う。 ※レポートライン：アプリケーショングループマネージャー 【その他】 AXBMGとの連携を密にとり、AXBMGマネージャーからの指示を受ける。

バイオサイエンス試薬を製造販売しております、外資系企業で、このたび画期的な体外診断薬を 初めて日本に上市いたしますので、大きなポテンシャルを持つ診断薬を導入していただける薬事申請のスペシャリストを募集しています。 ■　診断薬の許認可申請経験者 ■　製薬会社での勤務経験 ■　英語力あれば尚可

職務内容 ・ GCP監査業務－臨床試験が「医薬品の臨床試験の実施基準に関する省令(ＧＣＰ)」、「薬事法」、「治験実施計画書」、「標準業務手順書（SOP）」などを遵守して実施されているか否かを評価 ・ 内部監査－Globalの品質ポリシーと薬事法に従って卸売一般販売業務が適切に実施されていることを評価する　（出張有）　 ・ SOP作成業務

Key Responsibilities: Maintain and implement procedures and facilities that maintain the safety of all persons on and around the BST sites. Giving advice on a range of specialist areas such as fire regulations, occupational health and environmental health. Carry out regular inspections to check that policies and procedures are being properly implemented and meet statutory requirements. Keep records of findings and produce reports suggesting improvements for line management, Leadership Team and Board of Trustees. Carry out incident and accident investigations, liaising with relevant authorities. Report findings and recommendations, which are then monitored. Develop preventative and remedial programmes. Circulation of safety information Risk assessments - monitor and review both routine and one-off activities Schedule and monitor safety procedures, equipment, inspections and drills Keeping records of safety training mandating training as necessary Ensure that appropriate designated and/or qualified personnel in place to meet statutory requirements. Ensure that all personnel receive any safety codes of practice which are relevant to their work and all relevant documentation pertinent to their children is made available to parents either as hard copy or up-to-date on the website Ensure staff and parent communications chains are functional and accurate Incorporate full safety induction training for all new staff and students and run refresher sessions for current staff. Participate in Emergency Planning Meetings with the Board Subcommittee, and initiate and maintain regular cross-functional staff safety meetings ensuring that safety matters are a routine part of the whole school’s functional agenda

The Industrial Physician will perform the following duties: § Provide medical expertise in the Japan region as well as occupational health expertise. The Industrial Physician will ensure that the Firm’s program incorporates the most current medical and occupational hazards facing the region today. He will also be available to review difficult Occupational Health cases, and will oversee the on site nurses from a medical standpoint; § Provide management support to Firm -HCM on policies based on national leave absence policies specificities; § Acting as a resource to the Benefits group to address issues related to Worker’s Compensation; § Advise on health insurance and local labour law in relation to medical case management of an employee whenever possible. § Provide medical supervision for the entire program in Japan. He will facilitate recruitment, training and management of the on-site nurse. He will review the program to ensure that it meets all the medical objectives set out in the strategy, and the quality of service meets the levels expected by both Firm and Vendor. To accomplish this he will periodically conduct audits of the program and report the findings to the Firm. As the Occupational Health program expands, the Corporate Health Physician shall provide as and when required by the Firm additional activities as follows: § Liaise with the Firm’s Human Capital Management (HCM)/Employee Relation (ER) Teams in AEJ. Together with the Firm, he will develop a Health Strategy and Health Management System. By developing policies and procedures and direct management, the Physician will ensure this strategy and system are correctly distributed and implemented into the region by our Occupational Health nurse. The Physician will ensure that the program incorporates the most current medical and occupational hazards facing the region today.

To provide case coordination and medical support to the occupational/industrial doctor as regard to advice on the result of medical examination under the Japanese OSHA (JICOSH) regulations. To provide health guidance to the employee directly and/or under the guidance of the Occupational/Industrial doctor as are specifically deemed necessary to strive to maintain their health according to the results of a medical examination. To notify employees on behalf of the Firm for medical check ups related to work time exceeding regulatory limits, conduct initial assessment and organize medical follow up based on abnormal findings. Escalate fitness for work issues (i.e. under prohibition of Employment of the Sick such as communicable diseases and other diseases under the ordinance of the Ministry of Health, Labour and Welfare), travel health, vaccinations and prevention of illness to the Occupational/ Industrial physician. Provide health education, health counselling and/or other health services as required and appropriate. To ensure that record of results of medical examinations are appropriately kept in a confidential & safe manner on behalf of the employer. To help provide an efficient delivery of all agreed Health Services to clients. To participate as key member or as a guest to Health & Safety meetings organized by the employer. To liaise with employer and employees in a timely, proactive fashion regarding health issues. Provide support to the Intl.SOS Health Coordinator and other team members medically and administratively

Health Services includes: · Employee Health Risk Management · Disability Management · Occupational Health and related functions · Other Wellness related agenda. · Business continuity plan The health coordinator will work closely with the Wellness Manager, HCM Asia or delegate in Japan as well as the Intl.SOS program manager (based in Hong Kong). Managing Risk of Employee Health ·Process and manage short term disability (from inception to closure/resolution of the case file ·Work with GS Benefits group to file Worker’s Compensation Claims (including to liaise with Labor Dept) if necessary ·Manage maternity leave and promote parent initiatives (note this is currently not a priority, yet could be back in the core scope) ·Develop managerial tools (i.e. workflow, Standard Operating Policies and Procedures) as deemed and required to monitor efficiency of the health programs Management of Occupational Health programs and other Wellness Responsibilities ·Plan, manage and coordinate OH-related preventative care programs (i.e. annual vaccination programs, health checks, ergonomics, trainings, etc) ·Plan, manage and coordinate wellness initiatives ·Provide support on development of Wellness Crisis management toolkit ·Manage administrative tasks (i.e. utilization costing, disability trends) of the team in an effective and timely manner ·Understand and manage the related cost of the Occupational Health services delivered within a set budget. ·Create required reports (i.e. monthly report to the Firm) in a timely manner, adjusting work hours to complete for submission as deemed necessary ·Any other duties as requested from the Firm (through Intl.SOS) from time to time.

An international prescription pharmaceutical medicine company is seeking a Regulatory Affairs Associate Director for their Tokyo branch. The Regulatory Affairs Associate Director will be responsible for regulatory filing and operation management. Responsibilities also include ensuring quality document, filing of each assigned project and getting approval. ・ Preparation of quality document packages required for IND amendments, Master files, and other regulatory submissions ・ Reviews submission related documents such as safety reports, clinical protocols, Investigator’s Brochure, SOPs, process descriptions, change controls to ensure compliance with authority guidelines ・ Assists in the development and maintenance of organizational systems for the department’s operational functions. ・ Strategy and schedule planning of filing ・ Negotiation with administrative agencies

・ 製造受託業者との折衝・調整 ・ 製造販売業者として、製造を委託している各業者とフランス本社との調整業務 ・ 薬事生産動態統計調査 ・ 医薬品の新規申請・一変申請(同一性調査、キット製品申請含む) ・ 生データチェックに関する及び行政対応 ・ 医薬品の外国製造認定申請及び行政対応 ・ 医薬品のGMP適合性調査申請及び行政対応

・がん領域の動物での評価に関しての企画、実施。プロジェクトに応じた最適化 ・他部門との協力体制の確立