・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

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

外資系ジェネリック医薬品メーカー　薬事担当マネージャーを募集。 【 職務内容 】 　医薬品の製造販売業および医薬品開発において、関係当局との折衝や申請書類の作成、承認申請業務等、薬事関係業務一般を行うとともに、薬事法を遵守し、関係業務がスムーズに遂行できるようにご活躍いただきます。 【 詳細 】 　薬事グループ業務（下記）のマネジメント 　◆ 開発に関する薬事業務 　　− 承認申請書のチェック 　　− 薬価等の申請、作成 　　− 当局とのコンタクト、ネゴシエーション 　　− 安全管理部門の薬事サポート 　　− 海外関係グループ会社と薬事分野での対応 　◆ 薬事一般 　　− 業許可等の申請、届出等 　　− 社内他部門と薬事業務の調整

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.

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

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。

Responsibility: Functions as Sales Manger for assigned Japanese Pharmaceutical Companies to obtain business for preclinical studies (Genetic Toxicology, Metabolism, Toxicology and Regulatory Consultation) and Phase I and IIa trials to be carried out in the US, UK or Germany. - Negotiates quotes, content of contracts and payment schedule. - Manages contract signing as well as invoice schedule and payment, and updates all of financial information to appropriate laboratories. - Oversees and coordinates and manages preclinical studies carried out in theUS , UK and Germany as a local contact in Japan. - Arranges for scientific visits and seminars in Japan for specialists from the US, UK and Germany.

- Develop current and future business process models or procedures. Formulates needs assessment reports, requirement analyses and technical/functional specifications for new and enhanced systems. In addition, authors relevant validation documentation, including Standard Operation Procedures, in support of enterprise validation requirements. - Provides support for systems and processes by responding promptly to end-user inquiries and reported problems. Retrieves necessary information from or about systems to fulfill end-user requests. Seeks solutions by interacting with internal or external experts. - Proposes potential solutions or changes to existing processes or systems using knowledge of new technologies. Identifies new opportunities for enhancement utilizing prototyping, benchmarking and other proofs of concept. Keeps current on technology advances in industry. - Interacts with clients across departments and external contacts. Creates and encourages cross-functional relationships.

Our Client is a Global leader and innovator headquartered in Europe. Strong Industry reputation with leading products, people and working conditions. Sales growth has been ahead of the market average the last 5 years. Responsibilities: Manage a cross functional Project team to develop key pipeline products in Japan Plan and Manage the study group for successful results Training team (DM’s, Biostats, CRA’s, Project Leaders) when necessary High-Quality monitoring for compliance of GCP and SOP

Responsibility: - Member of the legal department in Japan. - Advise internal clients and counsel across the full range of legal and business areas. - Manage legal aspects of complex cross-border transactions in a team. - Liaise with business management and operational staff.