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427 listing(s) available.

  • 05 Mar 2019

    Site Manager (non-line manager)

    Japan

    Permanent Position
    アメリカ系製薬企業 - 深刻な病気を抱える患者さんを助けるための革新的な医薬品を開発し、提供することを使命とするグローバルなバイオファーマ製薬企業です。

    Job Description

    Demonstrates a thorough understanding and knowledge of all steps in the clinical research process. 
    Knowledge of GCP, ICH as well as local regulations.
    Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
    Site Manager – 2-3 years industry related experience as study team leader
    can manage basic discussion in English within the responsible job-related topics, can join discussions in a global meeting, either in face-to-face or through phone. 

    概要
    臨床試験に係る規制要件であるICH/GCP、ガイドライン、標準業務手順書(SOP)、Site Monitoring Plan(SMP)、治験実施計画書、その他適応される規制要件およびガイダンスに従い、臨床試験を実施する。
    スタディチームメンバーと協働し、臨床試験実施における担当業務の進捗状況を自己管理する。
    治験実施医療機関レベルの全般的な問題/課題を自ら予測/特定、解決する。
    予算およびリソースを最大限に活用する方法を策定し、シニアサイトマネジャー、サイトマネジャーおよびラインマネジャーと協働し、目標達成に導く。
    業務の価値を高めるような業務プロセスまたは役割の変更等に取り組み、業務効率化を推進する。

    役割
    プロジェクトの目的を達成するために、社内のステークホルダーと密に連携し、試験の進捗を管理する。
    治験を適切に実施できる医療機関/治験責任医師の情報を収集、選定する。
    Clinical Trial Management Systemを用いて、治験情報を管理する。
    シニアサイトマネジャーおよびサイトモニターと協働し、タイムラインに沿った症例登録の戦略を構築、進捗を管理する。
    スタディチームメンバーと治験実施医療機関における情報を共有し、担当医療機関における問題を事前に特定、解決案を提案、実行する。
    スタディチームメンバーと協働し、治験開始に必要なドキュメント、資料を作成する。
    治験実施医療機関からの問い合わせ、質問に対して自主的に回答し、解決を図る。
    サイトモニターと協働し、治験実施医療機関またはCountryレベルの潜在的なリスクを特定し、解決策を提案する。
    試験関連文書、必須文書が適切に管理、保管されていることを定期的にレビュー、確認する。
    GCP、ガイドライン、社内/治験実施医療機関のSOPに従った治験依頼、手続き書類作成、治験費用および契約の交渉、契約締結において、サイトモニターをサポートする。
    SMP、SOP、GCP、ガイドラインおよび規制要件に従い、被験者の安全性を確保する。
    モニタリングを含む臨床開発業務の効率化/標準化を図ることで業務を簡素化するとともに、求められる質を維持するためのツール作成やトレーニングの実施等の方策を講じる。
    予算およびリソースの有効活用を最大化し、目標達成に向けて革新的なアイディアを提案し、目標達成に導く。
    スタディチームメンバーをメンタリングする。
    組織内で求められるワークキンググループ、タスクフォース、SME(Subject Matter Expert)に貢献する。
    必要に応じ、規制当局による調査に対応する。
    CROおよび社内ステークホルダーと協働し、Outsource試験を管理する(実施する場合)。
    ラインマネジャーより任命されたその他業務を遂行する。

    Expires on 13 Apr 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 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    学士(ライフサイエンス、保健、薬学、看護の分野が望ましい)または臨床分野における同等の経験。
    ICH-GCP、ガイドラインおよび日本の規制要件に関する知識。
    2-5年以上の臨床開発業務経験。
    担当プロトコールおよびその対象疾患に関する知識を習得する能力。
    効果的な計画立案および物事をまとめるスキル、効果的かつ効率的に業務を遂行する能力。
    社内(グローバルレベル)およびすべての関連する外部関係者と良好なコミュニケーションが取れる。
    英文メールの読解・作成およびモニタリング報告書作成ができる程度の英語力。
    高い水準の柔軟性を示し、部門のために模範となる。
    他部署や部門横断的な役割に関する洞察と知識。
    関係者とのオープンかつ頻繁なコミュニケーションのための、種々テクノロジー(e-mail、teleconference 等)を活用できる。
    出張費用等のコスト管理意識。

    Job Requirements/Education:
    Experience of global studies in I/O area is preferable

    A University degree in Life Sciences, Pharmacy, Nursing or equivalent. 

    給与:前職考慮

  • 05 Mar 2019

    Medical Affairs TA Metabolism Diabetes 1 CDMA / 医薬開発本部CDMA代謝内分泌領域糖尿病第1グループ

    Japan

    Permanent Position
    ベーリンガーインゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    <Basic Purpose of the job> 

    To contribute to execute CDMA activities in Japan according to TA strategy between start of preclinical development and late stages of commercialisation.



    <Accountabilities>

    1. Contribution to CDPs after proof of concept and late stages of commercialisation

    ・Make contributions to the CDP based on medical need, TA strategy and insights obtained from FBMA



    2. Prepare local Integrated Brand Plan & Detailed Annual Operational Plan to include Japan specific needs, together with Marketing and Market Access & aligned with global IBP

    ・Timely availability of local IBP and timely execution of local IBP activities



    3. Budget control

    ・Adhere to effective cost management according to budget



    4. Contribution to benefit/risk evaluations of products

    ・Availability of adequate benefit / risk evaluations at all documents for product



    5. Ensure external expert engagement aligned with MSL and according to IBP

    ・Identify and classify individual customers

    ・Interact with and engage scientific external experts and societies.

    ・Maintain close contact with key scientific external experts and societies

    Expires on 13 Apr 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 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    <Required Skills>

    Special Skills

    ・In-house coaching skill (社内コーチングスキル)

    ・TA experience in clinical or research setting. 

    ・Strong negotiation and communication. 

    ・Leadership. 

    ・English speaking



    <Language Skills & Proficiency>

    Japanese: Native level

    English: Business 

  • 05 Mar 2019

    Statistician Biostat & Data Science JP Dept, Medical Div. / 医薬開発本部データサイエンス部統計解析グループ

    Japan

    Permanent Position
    ベーリンガーインゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    《Basic Purpose of the job》

    Act as Trial Statistician (TSTAT) or Trial Statistician-Translational Medicine and Clinical Pharmacology (TSTAT-TMCP) for routine phase I-IV clinical trials

    or

    Act as associated TSTAT or TSTAT-TMCP for complex phase I-IV clinical trials

    or

    Act as associated Project Statistician (PSTAT) supporting the responsible T/PSTATs or T/PSTATs-TMCP or PSTATs-Medical Affairs (PSTATs-MA) for projects with established BI experience

    or

    Act as PSTAT-Asia for projects with established BI experience

    《Accountabilities》

    1.Act as TSTAT or TSTAT-TMCP for routine clinical trials with existing statistical standards.

    The responsibilities cover, e.g.:

    - writing the statistical section of the clinical trial protocol

    - reviewing case report forms

    - specifying/reviewing the randomization

    - presenting critical statistical aspects at investigators meetings

    - preparing the trial statistical analysis plan

    - supervising the analyses

    - interpreting and communicating the results

    - participating in the writing of an accurate, high quality clinical trial report and of publications thereof.

    ・Timely availability and quality of trial deliverables as outlined in the TSTAT task list. 

    ・Feedback from other team members within function and across functions.

    2.Support other TSTATs or TSTATs-TMCP in their responsibilities. 

    Support PSTATs, PSTATs-TMCP or PSTATs-MA in their respective responsibilities.

    ・Feedback from supported functions.

    3.Act as PSTAT-Asia for projects with established BI experience.

    The responsibilities of a PSTAT-Asia cover, e.g.:

    - collaborate with PSTAT, TMM, TMM Asia (if appointed), PCPK Asia (if needed) in developing the clinical development plan and core project elements to approach Asian regional issues in line with regulatory requirements/recommendations 

    - collaborate with PSTAT to the project statistical analysis plans from regional perspectives

    - collaborate with PSTAT-TMCP and PCPK Asia to plan and supervise all meta-analyses/pooled analyses of PK, PD and biomarker data to support submissions in China and Japan

    - take on key statistical responsibility in the planning and preparation of regulatory submissions in Asian countries 

    - participate in the writing of the integrated summary documents for submissions in Asian countries and of publications thereof

    - participate in internal presentations for management decisions on further development steps in Asia

    - provide and organize statistical support for regulatory meetings, questions and submissions in Asian countries

    - represent the company in negotiations with regulatory agencies in Asia or other external decision making bodies on statistical-methodological issues relevant to Asian development/submissions

    - actively contribute to the MSTs 

    - support the lead PSTAT or PSTAT-TMCP on the project by keeping him/her informed constantly and by contributing to the submission; OR 

    - collaborate with PSTAT-MA and TM-MA in developing the market access strategy in Asian countries

    - collaborate with PSTAT-MA on continued safety surveillance and monitoring of the benefit-risk balance of product in Asian countries 

    - collaborate with PSTAT-MA and Global Epidemiology to identify real world data gaps and needs as well as to plan and analyze non-interventional studies in Asia.

    ・Timely availability and quality of project deliverables according to internal and formal timelines.

    ・Feedback from other team members within function and across functions incl. outside experts and regulatory authorities.

    ・Availability and use of efficient standards.

    ・Acceptance of development plans and submissions by regulatory authorities.

    ・Acceptance of publications by journals.

    4.Prepare specifications for data analyses of routine clinical trials by outside vendors. Assure compliance with the specifications by reviewing the vendors' products. Release of vendor’s product.

    Assist other statisticians in preparing specifications for data analyses of complex clinical trials by outside vendors. Assist other statisticians in assuring compliance with the specifications by reviewing the vendors' products.

    ・Timely availability and quality of specifications as well as level of compliance of vendor’s product with the specification.

    5.Provide necessary statistical and programming support needed for data mining and ad-hoc analyses within one or across several trial(s).

    ・Timely availability, quality and adequacy of data mining, ad-hoc or exploratory analyses.

    6.Support management in resource planning and tracking for assigned trials.

    ・Quality of data in the respective Clinical Trial Management System. 

    ・Level of pro-activity in sharing resource deviations from planned versus actual dates

    7.Supervise contract research organizations (CROs) for all statistical tasks with emphasis on analysis related processes. Prepare oversight plan. Assure compliance with the specifications by reviewing the CRO's products.

    ・Timely availability and appropriateness of oversight plan as well as level of compliance of CRO’s product with the specification.

    Expires on 13 Apr 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 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    <Required Skills>

    Special Skills

    - Good oral and written communication skills

    - Sound knowledge of statistical methodology, design of clinical trials and on processing clinical trial information

    - Ability to pro-actively identify data issues and solutions and to interact with internal and external bodies (specialists and non-specialists) on routine statistical/methodological issues at the trial level

    - Ability to supervise scientific/technical work at the trial level

    - Ability to write publications (as joint author) of clinical trials or on relevant statistical topics

    In addition for PSTAT-Asia:

    - Ability to successfully plan and conduct submissions for Asian countries including China and Japan for projects with established BI experience

    - Ability to successfully plan and conduct statistical activities to support market access activities, continued safety surveillance and monitoring of the benefit-risk balance of product, and non-interventional studies in China and/or Japan


    <Special working experiences>

    General work experience:

    - Doctoral degree: None

    - Masters degree: Three years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions

    Specific experiences:

    - Demonstrated ability to conduct and analyze a routine clinical trial under the supervision of a more senior statistician

    - Experience with communication and presentation of statistical information to non-statisticians

    - Evidence of strong teamwork at trial level

    <Language Skills & Proficiency>

    Japanese: Native level

    English: Business

    <Required education>

    Degree / education:Masters degree (e.g. MBA, MSc) or Doctoral degree (e.g. PhD, MD)

    Major, focus:Statistics or Mathematics or related field 

  • 05 Mar 2019

    医薬開発本部メディカルインフォメーションスタッフ/Medical Information Staff, Medical Div

    Japan

    Permanent Position
    ベーリンガー・インゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    <Basic Purpose of the job>

    1.To manage Medical Information activities in Japan in a compliant and sustainable manner, considering the overarching Japan strategy with specific focus on:

    - Respond to Medical Information inquiries

    - Manage Product Information

    - Provide scientific support related to Medical Information

    - Manage relevant digital channels and databases


    <Accountabilities>

    1.Develop and maintain high-quality, balanced and timely standard responses and frequently asked questions. Deliver responses to medical information inquiries upon the request of customers and internal stakeholders.

    ・Relevant KPIs and results from audits and inspections

    2.Manage product information, such as Interview Forms and Internal Databases and ensure that thein formation is accurate and up to date

    ・Quality checks

    3.Perform database searches for e.g. Clinical trial sand analyze publications to support Expert identification and Competitor intelligence

    ・Feedback from stakeholders

    4.Role as Key editor of Book and System Owner of Internal Databases relevant for Medical Information.

    ・Feedback from stakeholders

    5.Provide training on therapeutic areas, products and systems to DI center staff

    ・Quality checks and feedback from steak holders

    6.Provide reports and insights from Medical information databases to internal stakeholders

    ・Feedback from stakeholders

    Expires on 13 Apr 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 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    <Required Skills>

    Special Skills

    Knowledge of medical information processes and industry standards. Understands the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts. Understands drug development, health authority regulations and reporting requirements for adverse events and medical communications. Understands core IT infrastructure components and service concepts. Knowledge of interactive website development, implementation and optimization, data analytics tool utilization (e.g. Google Analytics or Adobe Analytics) and data visualizations. In-house coaching skill (社内コーチングスキル)

    <Special Work Experience>

    Medical science liaison or equivalent role experience

    <Language Skills & Proficiency>

    Japanese:Native level /Fluent (Read・Wright・Speak)

    English:Native level /Fluent (Read・Wright・Speak)

    Prior experience working with medical information or medical communication systems / databases. Demonstrated ability to work in a fast-paced, ambiguous environment while prioritizing and managing multiple responsibilities. Demonstrated experience communicating effectively across organizational structures and multiple management levels. Ability to successfully collaborate across multiple functions and departments. Excellent verbal, written, and overall communication skills for communication with global and local stakeholders. Business level Japanese and English in writing, reading, speaking and listening are mandatory.

    <Required education>

    Degree / education:Bacheloes Degree 学部卒
    Major, focus:Biochemistry 生化学、生物(生理)化学
    Bachelor’s Degree from an accredited university within life science.

    or equivalent knowledge 

  • 05 Mar 2019

    M&S Group Staff, Controlling Dept., Finance Div.

    Japan

    Permanent Position
    ベーリンガー・インゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    Description:



    Principle objective is to support/coordinate budgeting process and making financial reports/analysis,

    propose productivity improvements in responsible area. 



    Role and Responsibility:役割と責任

    医療用医薬品ビジネスの管理会計全般を支援する


    Ø 予算策定業務の支援

    Ø 各種予算会議資料の作成

    Ø 予実分析及び改善提案の策定

    Ø 標準原価管理、原価改善業務の支援

    Ø 月次、年次決算業務の支援

    Ø 各種レポ-ト、分析資料の作成

    Ø 各種プロジェクトへの参加及び支援

    Ø ドイツ本社のIncome Statement Guidelineや各種規定の遵守、日本の各種法令、規則の遵守
    •Budget & Forecast
    ◦Coordinate and develop the budget for responsible area, and support preparation for Annual Discussion. 
    ◦Closely monitor the changes in actual and planning to reflect them into Outlook 
    ◦Pursue savings opportunities by reviewing the process and alternative approach in the business 
    ◦Ensure accurate, timely, concise and readily understandable reporting of HP Business Unit status. 
    •Financial Analysis
    ◦Provide the risks and opportunities analysis for HP Business Unit.
    ◦Provide concise/timely financial analysis of projects/products/others in responsible areas.
    •Accounting Closing
    ◦Conduct monthly and yearly accounting closing in timely manner ensuring compliance with both German and Japan GAAP. 
    •Compliance

    ◦Ensure financial statements are prepared in compliance with the local and the Corporate guidelines and regulations.


    ◦Ensure proper use of accounting systems and software.


    •Communication


    ◦Communicate with business partners on a regular basis for budgeting/monitoring of actual.


    ◦Ensure accountability for financials deviations.

    Expires on 13 Apr 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 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    •2-3年の管理会計の経験 

    At least 2-3 year experience in Accounting and/or Budgeting 

    (preferably Controlling experience) 



    •日商簿記検定2級または同等の経験・スキル保有者

    Book keeping 2nd grade or similar accounting degree

     

    【歓迎(WANT)】

    •経営学・経済学などの4年大卒もしくはそれと同等の知識・経験

    Bachelor Degree in Business Administration, Economic, etc. or equivalent knowledge

  • 05 Mar 2019

    Local Infrastructure Manager (LIM), IT Infrastructure Services, Information Technolog

    Japan

    Permanent Position
    ベーリンガー・インゲルハイム - 全世界に145の関連会社と、約50,000人の社員を擁しています。 世界で3つの主要な研究開発拠点と、サポート拠点(日本)を持つ研究開発主導型企業として、グローバルに創薬活動を展開しています。

    Job Description

    End to end accountability for the overall management of the Local Infrastructure Management function (cross IT INF L3 functions) in the respective OPU. This includes responsibility for the stability, cost efficiency and local delivery of all IT INF processes and services. The Local Infrastructure Management function will be responsible to ensure appropriate implementation and operation of all local Infrastructure activities in the defined OPU. This includes general IT INF local projects(cross L3 functions) and the execution of global/regional projects on local level. Assumes responsibility for all Infrastructure activities performed in the defined OPU, as well as to ensure local demand alignment to global process. Increase efficiency and effectiveness of IT processes by providing direction in use of state-of-the-art IT technologies and methodologies.

    Drives strategic alignment with other IT INF departments/L3 functions and supports global harmonization of IT services and IT processes.

    Improve the overall IT INF customer satisfaction of defined OPU with excellent stakeholders management/engagement & local awareness event/training eg: Experience IT event, Training & Key User Meetings...etc. Seek for Innovation in the field of responsibility and beyond and implements them to create business value.

    Duties & Responsibilities:

    Contribute to improvement of efficiency and effectiveness of IT INF operational & processes by applying adequate IT Strategies and technologies in the defined OPU, with good alignment with respective IT INF function.
    Local support for all program/project management activities in the defined OPU in compliance with all PMO guidelines.
    Act as a main point of contact between the local IT demands and the Global/Regional IT INF organization. Responsible for proper communication between global/regional and local IT functions as well as local businesses.
    Act as administrative manager of IT INF team in the defined OPU and proactively communicate/align with the respective functional managers in the INF organization.
    Promote a culture of innovation to foster a competitive advantage in Infrastructure Enabling Services via technologies.
    Accountable in the defined OPU for: 
    -Act as main point of contact for Infrastructure Domains 
    -Operational Execution of global standards in the assigned countries 
    -Audit remediation 
    -Patching Compliance 
    -Technology migration 
    -New platforms incorporation 
    -Infrastructure support and delivery of local IMAC/R services 
    -Back up, archival and DRP for local INF indispensable systems support

    Expires on 13 Apr 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 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    Must have an good understanding of IT Infrastructure technologies and implementation experience. (eg: ITIL, PC, mobile, Windows platform, Cisco technologies, cloud & data center environment)
    Must have a good track record in implementing mid to large scale IT INF projects.
    At least 2-4 years of leadership & people manager experience is required.
    A motivator with excellent people management & conflict management skill.
    Good understanding of both IT and business with strong customer focus & vendor management skill.
    Able to demonstrate strongly in Accountability, Agility & Intrapreneurship 
    Global communication sklil : Japanese Fluent, English Fluent 

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