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289 listing(s) available.

  • 16 Feb 2019

    【研究開発本部バイオメトリクス】 Project Statistician (担当/担当課長/専門課長)

    Japan

    Permanent Position
    アメリカ系製薬企業 - 1876年に創業、140年を超える歴史がある。米国インディアナ州インディアナポリスに本社を置く、革新を追求する医薬品のリーディング・カンパニーです。世界各国の自社研究施設や外部の優れた科学的研究機関との提携による最新の研究成果を用いて、各治療領域で最高レベルの豊富なポートフォリオの医薬品を開発しています。世界120ヵ国以上で事業を展開しています。

    Job Description

    【職務概要/Overall Job Purpose】
    Provide strong statistical leadership in the process of drug development.
    The Project statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.


    【主な職責/Primary responsibilities】
    Statistical Trial Design and Analysis
    ● Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
    ● Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
    ● Collaborate with data management in the planning and implementation of data quality assurance plans.
    ● Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
    ● Participate in peer-review work products from other statistical colleagues.

    Communication of Results and Inferences
    ● Collaborate with team members to write reports and communicate results.
    ● Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
    ● Respond to regulatory queries and to interact with regulators.

    Therapeutic Area Knowledge
    ● Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

    Regulatory Compliance
    ● Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training. 

    Expires on 18 Mar 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)

    Tel: 080 1118 4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須経験(Required Experience (mandatory for hiring)】
    ◆ M.S. or Ph.D. in statistics or biostatistics.
    or
    ◆ Rich experiences in healthcare field as a statistician with science background such as mathematics or epidemiology.

    ◆ Ph.D. more preferable


    【望ましい経験/Desirable Experience】
    ◆ Experiences of collaboration with team outside of Japan (preferred: overseas living experience)


    【必須応募資格/Essential skills and license (mandatory for hiring)】
    ◆ Statistical and methodological knowledge in clinical development, epidemiology or related field.
    ◆ Regulatory knowledge of clinical trial methodology and statistics. 
    ◆ Ability to build relationships with individuals and teams.
    ◆ Strong English and Japanese communication and presentation skills


    【望ましい資格/Desirable skills and license】
    ◆ Proficient in the SAS programming language 

  • 15 Feb 2019

    Sr. Mgr., Compliance Investigations

    Malaysia

    Permanent Position
    American medical equipment company specializing in artificial heart valves and hemodynamic monitoring. Now, the company has grown into a global company with a presence in approximately 100 countries and more than 11,000 employees around the world.

    Job Description

    The Compliance Investigations role is an integral component of the ethics and compliance program by identifying, examining and mitigating compliance risk to the company as well as evaluating and strengthening the effectiveness of the compliance program.  This role is also important in cultivating a culture of compliance at the company.

    • Lead and conduct internal investigations and review deviations from policies, procedures and the Titanium Book all of which are brought forward from the various avenues of the Speak Up program; work directly with internal and external legal counsel in complex investigations providing both subject matter expertise and management to ensure timely and thorough completion.
    • Develop and document relevant remediation action plans as coordinated with the business owners based on root cause analysis; follow-up on all action plans to ensure timely implementation.
    • Maintain all related case information in tracking systems used for case management and reporting; ensure data is timely input, accurate and consistent.
    • Develop content, analyze data and occasionally present, all interim and ad hoc reporting on investigations, metrics and analytics.
    • Assist/coordinate in monitoring compliance investigation activities as needed.
    Expires on 01 Mar 2019

    Posted By

    Jane Loh

    Tel: 03-2263 4815

    janeloh@pplefirst.com

    Requirements

    • Bachelor’s degree, or equivalent, in Accounting/Finance or a related field with 10 years of relevant professional experience in Internal Audit and/or Investigations and a CICPA or equivalent.
    • Able to solve diverse compliance issues while exhibiting sound judgment and objectivity; systematic approach to decision making; strong attention to detail; solid analytical/problem solving skills; determining root cause; and identifying viable and alternate solutions.
    • Proven successful investigation/project management in developing and executing all phases of an investigation plan including: collection, review and analysis of data, information and records; conducting interviews; documenting work completed; drafting findings and conclusions; accountability for successful completion.
    • Excellent verbal and written communication skills that are effective with the appropriate tact and diplomacy for all levels of the organization as well as for outside counsel.
    • Strong, independent ethical decision making with a demonstrated commitment to integrity and compliance; leads by example in cultivating the culture of compliance.
    • Must be highly collaborative with the ability to garner the trust of others, build productive internal and external professional relationships with the ability to influence others in a multi-cultural environment.
    • Ability to manage confidential information with discretion.
    • Ability to effectively coach and mentor diverse team members on investigation techniques and procedures.
    • Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) required; Experience in CONCUR, EthicsPoint, SharePoint, JDE a plus.
    • Fluent in English and Chinese
    • Travel 25% within Asia Pacific.
  • 15 Feb 2019

    Senior Systems Engineer, IT M&S, Information Technology

    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

    Please do not delete the headlines

    Description:

    The Senior Systems Engineer provides expert IT solution, consultancy and operational support to Sales and Marketing team in the global organization. In addition, the Senior Systems Engineer needs to execute critical projects under various programs and contribute to domain architecture capabilities. Through ongoing consultation with business clients, the Senior Systems Engineer identifies business needs, establishes scope and requirements, and provide innovative recommendations for process changes and/or technology-enabled solutions.

    The Senior Systems Engineer leads and manages IT projects from beginning to end, which includes defining technical scope and deliverables that support Business goals and strategies. The Senior Systems Engineer is responsible for engaging clients in analyzing, prioritizing and governing demand for IT services; accountable for all such IT services; and responsible for insuring that projects realize their intended Business benefits. Successful projects are expected to contribute to the overall performance of the Business.


    Duties & Responsibilities:

    •Provide ongoing operational support to Web Platform which includes Drupal, PHP, Veeva Vault and MySQL

    Act as a primary Subject Matter Expert (SME) for web platform, including application features and configurations, architecture, integrations and data. Should own the support model and play a key role in directing various levels of support teams to fulfill service requests and resolve incidents and problems. Additionally, Lead upgrades and enhancements task to the system, participate in defining solutions, manage development and be responsible for testing to ensure stable and successful releases on the website. The position also bridges the gap between local development vendor and global technical teams that support the platform.

    This includes vendor management in cases where a partner with vendor is required. Also work directly with business users and 3rd party partner users (e.g. brand agencies). It is essential that this position needs excellent communication skills and a high level of proficiency in

    English (speak, read and write). Additionally, it requires to work in an international environment and cultures.



    Provide expert IT consultancy and operational support

    Plan, design and build IT solutions to address business needs

    Take ownership of web platform support

    Administer services and application systems

    Prepare and maintain proper System Life Cycle documentation to ensure reliable support for our systems

    Actively collaborate with service teams in IT infrastructure (High Performance Computing, Networking, Data Center Operation, etc.) and liaise with external vendors for stable support and maintenance of our IT system landscape.


    Accountabilities:




    SME for Web Platform and All Applications Included in the platform

    Change Control: Assess, Approve, and Execute system changes (including release management)

    User Account Administration & Access Control

    Problem and Incident Management: Work with support team to resolve technical support tickets

    Maintain all Documentation (e.g. End user, support, system specs, etc.)

    Ensure the Security and Compliance of the System

    Provide business analysis service and act as technical project manager
    Expires on 15 Mar 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(MUST)】


    Required Capabilities (Skills, Experience and Competencies):

    •Bachelor’s or Master’s degree from an accredited institution required with a focus in Information Technology,or equivalent knowledge



    •Progressive IT and business experience of up to 5-7 years


    •Strong Technical experience in Drupal, PHP, MySQL up to 3 years


    •Strong knowledge is cache mechanism


    •Basic proficiency in SQL, XML, JavaScript, and HTML


    •Understanding of web analytics and tag management


    •Ability to communicate to business and IT contacts on a variety of topics


    •Understanding of relational database, client-server and data integration concepts


    •Demonstrated experience in working with cloud technologies and services


    •Experience in supporting and collaborating with an international technical and business analyst team.


    •Acting proactively with a strong sense of responsibility


    •Strong communication skills in English with a passion for working in a virtual, international and multicultural environment.


    Additional Preferred Capabilities:

    •Knowledge related to SentOS, Cache and server set up


    •Knowledge related to Virtualmin is a plus


    •ITIL certified


    •JIRA/Confluence experience


    Our Culture:

    人と動物のための革新的な医薬品に130年以上の歴史を持っていることは、研究主導型の製薬企業であることを象徴しています。当社は製薬業界においてトップ20社の一つで、今日までもファミリーカンパニーとしてあり続けてきました。 

    現在では、医療用医薬品、アニマルヘルス、そしてバイオ医薬品受託製造の3つの事業分野において、約5万人の従業員が革新的な価値を創造しています。当社は、2016年に約159億ユーロの純売上高を達成し、純売上高の19.6%に相当する、30億ユーロ以上もの資金を研究開発費に投資しております。

    給与:前職考慮のうえ決定します。
  • 15 Feb 2019

    東京モニター(経験者の方)

    Japan

    Permanent Position
    EPS - 日本のCROのパイオニアとして、1991年の創業以来、四半世紀にわたって、新薬開発支援等の多彩なソリューションを提供し、医療・ヘルスケア産業の発展に貢献してきました。

    Job Description

    《職務内容》

    医薬品開発に関る臨床試験、製造販売後臨床試験におけるモニタリング業務。

    Oneプロジェクト制により本質を深く本質的に理解し、
    Dr.と専門的なディスカションを重ねながら、高品質なモニタリング業務を行います。
    分業制ではなく、試験の立ち上げから終了までの一連の業務に携わることができます。

    ●リピートオーダー
    ●本質を捉えた、質の高いモニタリング
    ●Oneプロジェクト制
    ●チームワーク
    ●オンコロジー、再生医療
    ●人材育成
    ●バランスの取れたチーム構成
    ●豊富なキャリアパス
    ●仕事内容、ポジションにチャレンジできる

    Expires on 15 Mar 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

    【歓迎(WANT)】

    望ましい経験
    •質にこだわったモニタリング業務を行いたい方
    •新たな分野に積極的にチャレンジしていきたい方
    •プロジェクトリーダーやラインマネジメント等へのキャリアアップを目指したい方尚可


    給与は経験・能力・資格等考慮し、弊社規程に則して決定します。

  • 15 Feb 2019

    東京 医療機器開発モニター

    Japan

    Permanent Position
    EPS - 日本のCROのパイオニアとして、1991年の創業以来、四半世紀にわたって、新薬開発支援等の多彩なソリューションを提供し、医療・ヘルスケア産業の発展に貢献してきました。

    Job Description

    《職務内容》

    ・医療機器臨床試験(治験を含む)におけるモニタリング業務
    ・医療機器の品質管理に関連した手順書作成・必須文書の確認等の文書管理(Document Control)業務等
    ・新医療機器の治験計画届(製品概要書、プロトコール等)の作成
    ・治験実施に関わる書類および資料の作成

    Expires on 15 Mar 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(MUST)】

    望ましい経験
    【いずれも必須】
    ・医療機器または医薬品の臨床開発経験。
    ・意欲的に能動的に取り組める方。
    ・プロジェクトリーダーやマネジメント経験のある方、キャリアアップを目指したい方歓迎。


    給与は経験・能力・資格等考慮し、弊社規程に則して決定します。

  • 15 Feb 2019

    薬事【医療機器】

    Japan

    Permanent Position
    EPS - 日本のCROのパイオニアとして、1991年の創業以来、四半世紀にわたって、新薬開発支援等の多彩なソリューションを提供し、医療・ヘルスケア産業の発展に貢献してきました。

    Job Description

    《職務内容》
    医療機器開発における薬事業務

    1.治験計画届、承認申請書、その他治験実施や承認申請に関わる書類や資料の作成
    2.薬事戦略立案・調査業務
    3.薬事に関するコンサルティング業務

    Expires on 15 Mar 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(MUST)】

    【必須条件】
    ・薬事業務経験(医療機器または医薬品) 
     

    【歓迎(WANT)】

    【歓迎スキル、経験】
    ・臨床開発経験(医療機器及び医薬品)
    ・臨床現場での医療機器取り扱い経験
    ・英語力、コミュニケーション能力、文章作成力 

    給与は経験・能力・資格等考慮し、弊社規程に則して決定します。

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