キャリアクロス外資系求人サイト : バイリンガル向けの求人情報を毎日更新！外資系企業をめざすならキャリアクロス。 http://www.careercross.com/913199.xml Sun, 06 Jul 2008 22:18:22 +0900 CareerCross ・企業法務全般（契約業務、訴訟対応、M&A関連、取締役対応、知財関連、コンプライアンス対応など） ・社員教育－部内法務要員の教育・指導・管理 ・各種法律相談 http://www.careercross.com/0087889.html Fri, 04 Jul 2008 18:23:00 +0900 Duties: 1.Coordinate many functions of VP/ED in the dynamic environment of a new, international research and graduate training institute. Includes assisting with the preparation of plans, reports and meetings with institute staff, ministry officials, and public representatives. 2.Manage and schedule appointments, maintain calendars, coordinate correspondence, oversee travel plans. 3.Some translation and interpretation. 4.Take minutes and write reports in English and Japanese. 5.Carry out research online and in literature and prepare summaries. 6.Flexibility with working hours and some domestic and international travel Term This is a 3-year fixed term position with a 6-month probationary period with the possibility of promotion to a permanent staff, full-time position. Benefits Relocation, housing and commuting allowances, annual paid leave, summer holidays, national social insurance (shakai-hoken) includes health insurance, welfare pension insurance (kousei-nenkin-hoken), and worker’s accident compensation insurance (roudousya-saigai-hosyou-hoken). How to apply Please send resume and curriculum vitae in English and Japanese. http://www.careercross.com/0093111.html Wed, 02 Jul 2008 14:37:00 +0900 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 http://www.careercross.com/0078415.html Mon, 30 Jun 2008 17:31:00 +0900 With operations in nearly all 50 US states, our client is one of the largest providers of pharmacy and related services to long term care facilities in the US. Currently employing over 15,000 people worldwide. The Tokyo office is expanding rapidly and this role would incorporate a lot travel throughout the APAC area coordinating and monitoring clinical trials. Responsibility : Responsible for the day-to-day management of the statistical activities of the Biostatistics department. . Coordinate and/or conduct and/or participate, or manage, in any or all assigned biostatistical activities for the design, implementation, data summarization/statistical analysis and reporting of clinical trials http://www.careercross.com/0069649.html Mon, 30 Jun 2008 16:09:00 +0900 コンパウンディング工場において、製造プロセスの改善、品質改善、新規製品製造の立ち上げを行う。海外の工場や国内外の関連部門と協力し、グローバルの戦略に基づいた品質、生産性改善活動を推進。 ●品質、生産性の目標を達成する為、製造プロセスの改善計画の作成と実行 ●製品開発部門と協力し、新規製品の量産技術の確立と早期量産の立ち上げ ●顧客満足の観点より不良の対策、改善へのプログラムを実施。又、工程での品質不良対策 ●新規製造技術を開発、導入し、海外の工場に技術指導。　又、海外からの技術を積極導入し、自工場のプロセスを効率よく改善 ●品質システムの理解と生産現場への展開を図る http://www.careercross.com/00100063.html Mon, 30 Jun 2008 13:53:00 +0900 新規商品の太陽電池、建築、または自動車業界おける用途開発、市場開発を担当していただきます。 扱っていただく製品：　中間膜製品 ※詳細お気軽にお問い合わせください。 http://www.careercross.com/00100058.html Mon, 30 Jun 2008 13:50:00 +0900 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 http://www.careercross.com/0098936.html Mon, 30 Jun 2008 09:30:00 +0900 仕事内容///////////// ISO 13485、EC指令（93/42/EEC、90/385/EEC、98/79/EC)、米国要求事項または薬事法等、医療機器および体外診断用医薬品関連の審査・認証業務。 会社概要/////////// ドイツ系技術検査協会の日本法人で、125年以上の歴史を有するヨーロッパ最大級の公認機関のひとつです（世界拠点は300を超え、主要都市はほぼすべて網羅しております）。日本国内においても約100の民間ISO認証機関のうちトップ5に入る実績を持ちます。 世界に広がる各拠点には約8500名の社員が活動しており、年間売上高は7.3億ユーロです。50カ国以上に 80を越える子会社を有しており、したがって、ドイツ国外においても技術管理会社のトップに位置しています。世界に広がるネットワークで、お客様に納得のいくオールインワンのサービスを提供しています。 130年間に培われた伝統と実績で、インダストリアルエンジニアリングサービス、自動車・運輸、製品安全及び品質、教育コンサルティング、ITサービス・新技術の5つの分野で特に力をいれています。 http://www.careercross.com/0075588.html Sun, 29 Jun 2008 14:35:00 +0900 Our client, a group of companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life is seeking a Group Manager for their office in Hyogo. The Group Manager will be responsible for developing state of the art analytical methods (e.g., HPLC, GC) and conduct stability studies for new drug products in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) ・ Method development for new NCEs based on their phys. - chem. properties ・ Maintains and newly establish state of the art technology ・ Supports Pharmaceutical Research developing trial and final formulations ・ Designs and execute ICH and cGMP compliant stability studies applying newly developed analytical methods ・ Determines long-term stability and shelf-life of new drug products ・ Provides guidance to PHR wrt viable formulation approaches ・ Compiles stability reports ・ Summarizes all results and present all relevant data to the international R&D team ・ Communicates and implement all team decisions within the department (matrix management function) ・ Communicates and resolve conflict ・ Plans, prepares and conducts method transfers ・ Trains analytical staff and report results ・ Prepares submission documents for J-NDA and global MAA submissions ・ Interacts with DRA and CMC Experts on content and format of documentation ・ Contributes to establish proactive response strategies ・ Interacts with international regulatory bodies during the development (e.g, pre-NDA meetings, formal and informal discussions, etc.), submission, review and post marketing phase ・ Supports operations in performing quality investigations ・ Trouble shooting and problem solving for commercial products ・ Interacts with partners and customers ・ Coaches staff to acquire skills, help them to solve problems and develop their career plans ・ Provides staff with career development opportunities on-the-job and also off-the-job ・ Leads by example http://www.careercross.com/0081198.html Fri, 27 Jun 2008 17:50:00 +0900 The following are core activities for this position: - Train and mentor future product managers - Create, develop and execute marketing strategies that maximize market entry effectiveness - Be responsible for monitoring product performance and making plans for continual improvement - Develop promotional materials - Develop, maintain and expand network of KOLs - Organise effective symposiums - Work in a cross functional team both domestically and internationally http://www.careercross.com/0099859.html Fri, 27 Jun 2008 14:59:00 +0900