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189 listing(s) available.

  • 18 Dec 2018

    臨床薬理医師

    Japan

    Permanent Position
    創業当時から最新技術を取り入れ、米国の基礎研究所を中心に日本を含む世界9カ国に大規模なR&D(研究開発)設備を持ち、約8,800人の開発スタッフを雇用する。また、この会社は『Working Mothers magazine』2004年度の働く母親のためのベスト10において、1位の会社に選ばれている。 研究開発に投じる費用は22億ドル超、売上高に占める開発費の比率において、米国の製薬会社の中ではトップクラスの研究開発重視の企業である。 これまでに医薬を数多く創り出してきており、代表的なものでは糖尿病の治療に用いられるインスリン、細胞内寄生菌に有効なマクロライド系抗生物質、感染症治療に用いられるセファロスポリン系抗生物質、遺伝子組み替えインスリン等がある。

    Job Description

    【職務概要/Overall Job Purpose】
    臨床薬理の専門家として、日本の臨床薬理戦略のみならず、グローバル臨床薬理戦略の立案に参画し、化合物ごとに適切な臨床開発を効果的に行い、患者様に届けること。
    As a clinical pharmacology (CP) expert, contribute to the CP strategy development for Japan and also for global, for compound specific appropriate clinical development in order to effectively develop pharmaceutical drugs and deliver them to patients.

    【主な職責/Primary responsibilities】
    • 臨床薬理戦略の立案/Develop CP strategies
    • 臨床薬理試験の計画立案、プロトコール作成、試験実施の医学的面での監視、報告書作成/For CP studies, design studies, develop protocols, medical monitoring of studies, and complete study reports
    • 臨床薬理試験における安全性、薬物動態・薬力学の評価/Assess safety, PK and PD in CP studies
    • 薬事文書を含む臨床薬理関連の文書作成に関与/Contribute to reporting of CP data including regulatory documents


    【その他/Secondary responsibilities】
    • その他の臨床薬理に関連する業務/Other CP related tasks

    Expires on 17 Jan 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレス(nagai.m@pplesearch.com)までご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@pplesearch.com

    Requirements

    【必須経験/Required Experience (mandatory for hiring)】
    • 臨床経験1年以上/At least one year of clinical experience
    • 第Ⅰ相試験や臨床薬理試験の経験、または、臨床薬理分野の教育1年以上/ experience in Phase 1 or other CP studies, or at least one year of education in CP field


    【望ましい経験/Desirable Experience】
    • 製薬企業での臨床開発経験2年以上/At least two years of clinical development experience in a pharmaceutical company
    • 製薬企業又は臨床薬理施設での臨床薬理試験経験2年以上/At least two years of clinical pharmacology experience in a pharmaceutical company or clinical pharmacology site


    【必須応募資格/Essential skills and license (mandatory for hiring)】
    • 医師免許/Medical license
    • 臨床薬理および基礎的又はそれ以上の薬物動態学の知識/Knowledge of CP and basic or advanced knowledge of PK
    • 英語による業務が遂行できる程度の英語力、例えばTOEIC 850点以上/Fluent in English enough to conduct business in English, for example TOEIC score of at least 850 points
    • 日本語NetiveLevel

    【望ましい資格/Desirable skills and license】
    • ロジカルシンキング、クリティカルシンキング/Logical thinking, critical thinking
    • 問題解決能力/Problem solving skills
    • アクティブリスニング、アサーティブネス/Active listening, assertiveness 

  • 18 Dec 2018

    CDC(Clinical Development Consultant)(担当課長/課長)

    Japan

    Permanent Position
    創業当時から最新技術を取り入れ、米国の基礎研究所を中心に日本を含む世界9カ国に大規模なR&D(研究開発)設備を持ち、約8,800人の開発スタッフを雇用する。また、この会社は『Working Mothers magazine』2004年度の働く母親のためのベスト10において、1位の会社に選ばれている。 研究開発に投じる費用は22億ドル超、売上高に占める開発費の比率において、米国の製薬会社の中ではトップクラスの研究開発重視の企業である。 これまでに医薬を数多く創り出してきており、代表的なものでは糖尿病の治療に用いられるインスリン、細胞内寄生菌に有効なマクロライド系抗生物質、感染症治療に用いられるセファロスポリン系抗生物質、遺伝子組み替えインスリン等がある。

    Job Description

    職務内容   【職務概要/Overall Job Purpose】
    • 日本イーライリリー臨床開発本部のコンタクトパーソンとして、臨床試験の実施において協働する医療機関や医療関係者と、良好な関係を構築および維持する。
    • 臨床開発に関する専門的な知識と経験・疾患知識を通じて、国際共同試験及び日本単独試験において、日本の施設における成果物並びにスケジュールに責任を持つ。
    • 医療現場におけるニーズや患者さんのニーズを将来の臨床開発/臨床試験につなげる。


    【主な職責/Job Responsibilities】
    • 実施医療機関との良好な関係を構築し、Lilly/CROと医療機関の間で試験が円滑に進むようリードする。
    • 開発計画の初期段階において、日本における試験デザインおよび実施可能性へのインプットを行う。
    • 試験計画に沿って多くの症例登録が可能な実施医療機関を探索し、その施設におけるポテンシャルの維持・開拓を行う。
    • 臨床試験計画毎、および 実施医療機関毎における 正確な症例登録計画を立案し、確実に遂行する。
    • 実施医療機関における治験データの質を適切に担保する。
    • 医療現場におけるニーズや患者さんのニーズを収集し、社内医師や社内臨床試験実施チームに確実にフィードバックする。
    • 日本イーライリリー臨床開発本部の代表として、リリーブランドの構築に貢献する。
    Expires on 17 Jan 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレス(nagai.m@pplesearch.com)までご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@pplesearch.com

    Requirements

      【Required Experience: (mandatory for hiring)】
    •大学卒業
    •5年以上の臨床開発経験かつ3年以上のモニター経験(施設選定及び立ち上げ、症例登録経験を含む)
    •CROのみ経験の場合は、5年以上のモニター経験かつ3年以上のモニタリングのリード経験



    【Desirable Experience】
    •モニタリングのラインマネジメント経験
    • キーオピニオンリーダーとの協働を担当した経験
    • 第三者機関(CRO)との協働経験
    • 英語を用いたコミュニケーション(例:メール、電話、プレゼンテーション)が必要となる環境での業務経験
    • プロジェクトマネジメントに関する知識


    【Essential Skills/license: (mandatory for hiring)】
    • 社内外メンバーと自発的に協働して臨床試験を推進するリーダーシップ
    • 社内外メンバー、臨床医師等の外部顧客と円滑に協働することができるコミュニケーションスキル
    • 問題発見・解決能力
    • 英語力(英語プロトコル、手順書等を理解して業務できる基礎的な英語力を有すること:TOEIC 600点程度を目安)
    • PCスキル(Excel、Word、PowerPoint)


    【Desirable Skills/license】
    • 糖尿病、中枢神経系疾患、自己免疫疾患、癌領域疾患の専門知識
    • 英語力(日本以外の社員・関連担当者と意思疎通が図れるだけの基礎的な英語力を有すること:TOEIC700点程度を目安)
    • プロジェクトマネジメントに関するツール(例:リスクアセスメント、リスクマネジメント [ミチゲーションプラン、コンティンジェンシープランの設定] )を活用して業務を前に進めることができる能力
    • 複雑な組織の中で、複数のタスクを同時に前に進めることができる能力 
  • 18 Dec 2018

    Associate Clinical Operations Manager

    Japan

    Permanent Position
    150ヵ国以上で革新的な医薬品、栄養製品、診断用製品および医療用製品を人々に提供する製薬会社です。

    Job Description

    Purpose :

    To enable AbbVie’ s emergence as a world class R&D organization, the position is accountable for all activities of site related study execution directly or by leadership of assigned CRAs involving start­up, execution, and close­out.

     

    Responsibilities :

     

    •Accountable for all activities of site related study execution of assigned studies / Monitors involving start­up, execution, and close­out. Accountable for the on­time and within budget study execution of assigned projects, including but not limiting to country and site feasibility.

    •Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.

    •Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country / district, and provide impact analysis of significant changes affecting conduct of Clinical studies.

    •Ensure audit and inspection readiness of assigned sites. Advise on pre­audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.

    •Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.

    •Responsible for the acquisition and retention, performance management, and growth and development of talent. May be responsible for being the country point of contact for CROs for an assigned study / studies. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.

    •If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.

    •If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country­level information: Country­level planning timelines, LSR assignments, etc.

    •If assigned; Global Representative for single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.

    •If assigned; Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies. Responsible for the direct/functional management, as applicable, of the assigned Remote Monitors including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development.

    Expires on 17 Jan 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレス(nagai.m@pplesearch.com)までご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@pplesearch.com

    Requirements

    Qualifications :

    •Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred

    •Site Monitoring Experience: Minimum 3 years.

    •Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.

    •Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.

    •Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading(within country) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases.

    •Drives continuous improvement and simplicity in process and approach and enhances agility.

    •Demonstrated business ethics and integrity.

  • 18 Dec 2018

    Associate Logistics Manager (Order Management)

    Japan

    Permanent Position
    150ヵ国以上で革新的な医薬品、栄養製品、診断用製品および医療用製品を人々に提供する製薬会社です。

    Job Description

    PRIMARY FUNCTION/OBJECTIVE:

    The Associate Logistics Manager is responsible for order management activities for customers and transportation management working closely with third-party logistics service providers and BPO partner located in Dalian, China. Serves as the country customer’s point-of-contact regarding product availability, scheduling, delivery status; strives to maintain customer goodwill by providing responsive customer service.

     

    CORE JOB RESPONSIBILITIES:

    Order Administrations 

     Manage the entire ordering process from order entry to shipment, incl. good issue booking to the consigned stock at 3PL, and until delivery to the supplier

     Ensure Customer Service Performance meets Key Performance Indicators 

     Establish and maintain good working relationships with internal cross-functional teams and external partner and customers 

     Handle escalation and customer issues when needed

     Ensure proper documentation of all Delivery processes, which are in compliance with Corporate Policies on Revenue Recognition, Pricing, Business Ethics and Best Practices

     Ensure timely reporting of orders, sales, inventory and backlog performance 

     Coordinate, develop and implement all relevant ordering and shipping processes within a company and external customers/suppliers

     Work Instruction to Logistics Assistant pertaining to Order Administrations 

     Optimize all processes within the Supply Chain Management structure and establish a continuous improvement culture through a lean agile management. 

     Monitor and analyze efficiency, costs, quality and effectiveness of all order management processes to ensure well balanced results between customer requirements and cost/service structures. 

     

    Transportation Management

     Direct activities related to dispatching, routing, and tracking transportation vehicles, such as chartered and less-than-truckload carriers. 

     Direct investigations to verify and resolve customer or shipper complaints.

     Implement schedule and policy changes.

     Develop criteria, application instructions, procedural manuals, and contracts for outbound transportation collaborative with 3PL 

     Monitor spending to ensure that expenses of local transportation are consistent with approved budgets.

     Lead all distribution and transportation planning and strategic activities.

     Assist in the identification and implementation of continuous improvement opportunities and customer satisfaction opportunities.

     

    Master Data Maintenance

     Accountable for gathering information requirements and working with BPO partner to maintain Customer Profile and Material data pertaining to customer delivery in SAP.

     Responsible to ensure data quality and integrity for customer profile maintained in SAP.   

    Others

     Initiate or drive best practices through continuous improvement projects to improve customer satisfaction level, delivery lead time, productivity and cost effectiveness  

     Perform additional duties as assigned by Manager 

    Expires on 17 Jan 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレス(nagai.m@pplesearch.com)までご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@pplesearch.com

    Requirements

    PREFERRED :

     

     Bachelor’s Degree in any discipline with minimum 5 years of relevant working experience

     Previous Customer Service and/or Distribution/Logistics working experience in Healthcare Industry is preferable but not essential

     Strong ERP systems and computer software experience e.g. SAP, Oracle, Excel and Power Point. 

     Experience in day-to-day management of a geographically dispersed team including the various partners. 

     Good leadership, negotiation, presentation and problem solving skills.

     Excellent communication skills both in Japanese and English which include the ability to articulate and transfer information.

     Knowledge and experience managing 3PL’s will be highly regarded.

     The ability to work in a fast paced and changing environment and adapt order Management and Supply Chain skills to achieve Customers requirements.

     Strong problem solving and analytical skills with a demonstrated ability to handle Multi-tasking Supply Chain events. Candidate must possess a sense of urgency.

     Strong Excel, analysis, communication and presentation skills.

     Travel requirement: Some local and global travel required – typically not to exceed 10%.

  • 18 Dec 2018

    Clinical Research Associate

    Japan

    Permanent Position
    150ヵ国以上で革新的な医薬品、栄養製品、診断用製品および医療用製品を人々に提供する製薬会社です。

    Job Description

    Purpose :

    To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study­related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving start­up, execution, and close­out of studies. 

     

    Responsibilities :

    • Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. 

    • Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1­4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.

    • Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.

    • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow­up for all safety events by site personnel.

    • Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.

    • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. 

    • Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.

    • Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

    Expires on 17 Jan 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレス(nagai.m@pplesearch.com)までご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@pplesearch.com

    Requirements

    Qualifications :

     

    • Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.

    • Minimum of 1 year of clinically­related experience, of which a period of 6 months is preferable in clinical research monitoring. Experience in on­site monitoring of investigational drug or device trials is required

    • Current in­depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials. 

    • Current in­depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.

    • Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.

    • Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.

    • Demonstrated business ethics and integrity.

  • 18 Dec 2018

    Digital Customer Engagement Manager

    Japan

    Permanent Position
    150ヵ国以上で革新的な医薬品、栄養製品、診断用製品および医療用製品を人々に提供する製薬会社です。

    Job Description

    Major Responsibilities:

    The DCE role is a key multichannel management role that enables the marketing teams to effectively engage the customers of AbbVie Japan. DCE is dedicated to driving Digital Excellence across all functions of the affiliate in order to provide a superior customer experience.

     

    The candidate is responsible for providing strategic direction and tactical planning for AbbVie Japan and will support the development of AbbVie Japan into a Digital Leader in the Japan market. This will include supporting the Cross Functional Brand Teams with their multichannel planning, execution and assessments to ensure a continuous process of improvement.  This includes both front end and back end support for the teams.

    Expires on 17 Jan 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 下記のメールアドレス(nagai.m@pplesearch.com)までご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@pplesearch.com

    Requirements

    Essential Skills & Abilities:

    Strategic Planning

    ・  Understand the Affiliate Digital Strategy and provide key insights and guidance to the future developments of the strategy to ensure AbbVie’s leadership in the market.

    ・  Work with the Brand Teams to develop plans that are aligned with the Affiliate Digital Strategy. 

    ・  Ensure that Brand Plans integrate the channels that best engage our HCPs (and Patients) and provide guidance with the necessary information that will enable the Brand Teams to engage their customers effectively to meet their objectives.

    ・  Ensure that clear tracking measurements are identified and included in the Brand Plans.

     

    Tactical Implementation

    ・  Work cross-functionally to support the execution of the Brand Plans.

    ・  Support the execution of the digital activities of the Brand Team including establishing the channel mix, KPIs, and assessments of the results.

    ・  Utilize data to drive decisions.

     

    Internal and External Partner Management

    ・  Partner with the Brand Teams, BTS (IT), Customer Excellence, and agencies/vendors to identify the solutions that will achieve the Brand Teams’ objectives.

    ・  Provide guidance and support for the implementation of the multichannel plans, ensuring strict compliance with promotional guidelines.

    ・  Partner with and manage Agencies/Vendors.

    ・  Train and develop the multichannel competencies of the Brand Teams as needed.

     

    Education/Experience Required:

    ・  Strong cross functional communication skills, including presentations and negotiations in English and Japanese

    ・  Ability to work effectively as part of a team

    ・  Project management of cross functional teams

    ・  An understanding of digital channels with planning and implementation experience

    ・  Agency and vendor management

    ・  An understanding of DATA and the ability to drive the PDCA cycle

    ・  Experience with Multichannel solutions and/or applications such as; Veeva, Websites, Portals, Mobile Apps, eMail, Marketing Automation

     

    ・  Experience with various systems’ back office operations

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