●肌と髪に関する応用研究　　 ●日本、アジア、世界各国向けの製品開発 ●マーケティング部との協力による処方開発　　 ●世界各地のＲ＆Ｄとの企画運営 ●原料・競合製品の研究　　　 ●特許分析

【 このポジションの魅力 】 半導体工程等の新規用途分野において、顧客ニーズを先取りし、製品仕様及び材料設計から実際の開発業務及び生産立ち上げのサポートを行うなど自分自身で開発プロジェクトを推し進めることができます。 【 職務内容 】 　ドライフィルムフォトレジスト材料の要素技術開発及び製品開発 ＜具体的には＞ 　●プリント配線板や半導体後工程などで用いられるドライフィルムフォトレジストの組成開発 　●上記フォトレジストに用いられる新要素技術開発 　●上記フォトレジストの新規用途開発のサポート 　●上記フォトレジストに用いられる組成材料の評価、認定作業 　●開発製品の量産立ち上げと工場への生産移管（国内、海外）サポート 　●上記フォトレジスト材料の製造エンジニアリングサポート

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

主な職務内容 グローバルの研究開発チームの一員として海外担当者とのインターフェースを担い、日本その他アジア地域における当社商品の処方開発を担当する。原料処方のエキスパートとして、他部門（マーケティング、サプライサービス、薬事、品質管理部門等）と協力し、消費者のニーズや要望を取り入れながら高品質かつコストセービングな商品を開発してビジネスに貢献する。東南アジア地域のR&Dディレクターへレポート。

＜通常で行われる業務＞ ・受託プロジェクトの治験実施計画書に基づいた業務 ・治験チームで作成するモニタリング管理計画書（GCP）モニタリング業務を実施 ・タイムラインに合わせた業務の品質基準プロジェクトの遂行 ・新GCPや治験実施計画書、標準業務手順書などに準じた監視と適切な実施、記録、報告 ・治験実施施設の治験進行状況や、治験実施報告書の内容把握し、治験実施施設での情報収集 ＜その他の関連業務＞ ・治験実施前に治験を行う医療施設や治験責任医師の選定を行ったり、治験薬の搬入業務

Clinical development for one of the world’s leading pharmaceutical companies are seeking a clinical specialist for Vaccines Responsibilities: Clinical development for vaccines (excluding clinical monitoring) ・Drafting and reviewing of trial protocols, trial journals, etc. ・Take the initiative in corresponding with the authorities in regard 　to planning of organization consulting strategies, etc. ・Act as a Japanese contact for franchise trams of each overseas 　　　product. ・Take the initiative in tasks related to clinical part application 　　materials, handling of correspondence, etc. ・Responsible for clinical tasks of a project team. ・Staff training with long-term perspective.

- PKDM Manager (for both preclinical and clinical) - PKDM organization builder

MAIN RESPONSIBILITIES : Create, implement and maintain complaint handling systems, ensuring accuracy in report data as well as trend analysis Support regulatory compliance and optimize quality system procedures relating to product complaint handling Put in place guidelines and proactively steer team to comply to PAL, GMP, GQP and the Global Quality System Provide key knowledge as a resource and support the development, implementation and maintenance of complaint handling processes, quality metrics etc. to drive improvement in complaint handling Work closely with, and communicate with key managers, in the R&D, Sales & Marketing, Manufacturing, SCM etc. to provide complaint data to further push for higher productivity, and high product quality Put in place tracking metrics and lead team in strategizing and driving processes for increasing productivity levels in current complaint handling procedures and processes Coach team and drive change initiative across the board to push for complete adherence to quality issues Build growth oriented environment and steer team towards achieving quality targets Identify key personnel to invest and further develop

You will be responsible of: -Project Manager in planning and execution of global clinical project -Liaise between Global Project Team and Japan Business Unit, including Clinical, Pre-Clinical, RA, Sales & Marketing -Overall coordination of clinical development projects areas -Communication with global project team members, leading meetings and presentations, project plan implementation, time-line coordination, scope and budget coordination and reporting project status to Senior Management

US based manufacturer and distributor of pharmaceuticals, consumer products and nutritional around the world. It is crucial for the company to continue to grow its strong business in Japan by bringing new products to market continuously and quickly. To facilitate its efforts, the company is seeking physician to play a key role in its clinical development team in Japan. - Provide detailed counsel on documentation on both Japanese and English to facilitate effective approval by the authorities. - Serve as an active participant in the management team and Japan Brand Development Committee for helping to set strategy and direction for driving the business. - Develop and communicate a compelling vision for the clinical strategy that is aligned with the overall business strategy and driven by a strong personal "teachable point of view" that motivates the team. - Build a high performance team by training and developing the staff, providing ongoing coaching and counseling, retaining the best talent through motivation and recognition, and making tough decisions on non-performers, with focus on quality and urgency. - Interface effectively with headquarters and the regional office and exert influence with authority to ensure allocation and mobilization of resources into the most appropriate areas. - Implement clinical / registration trial programs from the headquarters whose outcomes will accelerate registration of the company’s new drug entities worldwide and locally. - Develop Japanese protocols and clinical trials that are relevant to Japanese business needs and within time, budget and good clinical practice (GCP) requirements. - Build and maintain a strong relationship with Regulatory, Clinical Operation, Medical Affairs and Pharmacovigilance and other functions in the Japan organization, and with headquarter support staff, so as to capitalize on opportunities to enhance performance. - Establish and maintain excellent working relationships with opinion leaders, academic professional and government centers, organizations involved in new drug development in order to create a positive impact on the Company image and business goals. - Leverage in regulatory activities to achieve regulatory approval in a timely manner. - Facilitate publication of clinical trial results in reputable Japanese and international journals to ensure universal acceptance of data by the medical community and support for product launches and registration. - Provide support, advice and quality assurance to the sales and marketing departments.