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Latest Jobs

427 listing(s) available.

  • 20 Feb 2019

    オンコロジーメディカルアフェアーズ メディカルアドバイザー

    Japan

    Permanent Position
    MSD - グローバルヘルスケアリーダーMerck & Co., Inc., Kenilworth, N.J., U.S.A.の一員として、日本の皆さまに医療用医薬品やワクチンをお届けし、革新的なヘルスケア・ソリューションを提供しています。強固なパイプラインと世界140カ国以上で事業を展開するグローバルなネットワークを活かし、未だ満たされていない日本の医療ニーズに積極的に応えていきます。

    Job Description

    Role Overview:
    Oncology Medical Affairs
    The Medical Advisors(MA) is responsible for the medical strategy of the product, provides medical and scientific expertise to maximize medical communications.
    The MA is the responsible person to lead the indication team and develop/execute Country Medical Affairs Plan (CMAP).
    The MA is the Scientific expert and Key person to manage the complete products life cycle management by proactively involving all required stakeholders (Science Hub)

    Key Accountabilities:
    Medical Strategy
    Identify Medical Needs and Data Gaps and lead the preparation and implementation of the medical strategy (including launch strategy) in alignment with all stakeholders (Marketing, Global Medical Affairs, Development, Oncology Scientific Affairs) documented in the country medical affairs plans (CMAP). 
    Communicate with the global functions in regards of the product lifecycle management and global alignment of the medical strategy
    Insights evaluation and management through Scientific Leader (SL) interaction 
    Develop and Manage the CMAP and SL engagement List in collaboration with Medical manager, MSL and MI.
    Build and maintain relationships with important SLs (Local and Global) through scientific interactions (Scientific discussion) and peer-to-peer communication.

    Data Generation
    Plan data generation (DG) strategy to maximize the scientific value of products in line with the local medical and brand strategy.
    Lead local DGs from scientific and strategic viewpoint , as well as execute non-intervention post-marketing studies as the responsible person in collaboration with working-level colleagues as needed.

    Internal Expert & Collaboration
    Educate and inspire medical affairs staff to have the highest scientific standards
    Give proactive scientific and medical direction to MI and MSL: lead the Medical Affairs product related scientific activities
    Support Sales force training upon request from Oncology Business Unit.
    Act as a bridge between clinical development and commercial teams: lead the cross-functional medical activities.
    Review external documents on their clinical/scientific adequacy to deliver a balanced message based on scientific evidence

    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

    必須条件:
    Medical Affairs部門にてMedical Strategy立案・実行の経験を有する方
    英語ビジネスレベル

    望ましい条件、資質: 
    Medical Affairs部門にてMedical Strategy立案・実行の経験を有する方(Oncologyの経験があることが望ましい)

  • 18 Feb 2019

    Site Activation Lead

    Japan

    Permanent Position
    ICON - 世界でも5本の指に入るほどの規模と実績を誇るCRO。世界23ヶ国に拠点を持ち、約3600名の社員を抱え、その日本法人である当社は海外オフィスと協力し、海外での治験データを活用して日本での治験を簡略化させる今注目の「ブリッジング」や「グローバル試験」を実践。効率的な治験の実施に向け、戦略的に取り組む製薬メーカー様より大きな信頼を得ています。

    Job Description

    Role Summary
    Our Study Start-up Services are building for a bright future. Site activation is currently one of the most challenging aspects within the project lifecycle. Due to the fast nature of the business Study Start Up works within, we’re looking to develop our team to reach for new frontiers of performance and quality. You will be responsible for the coordination and lead of the country Study Start Up teams for multi-country studies; Driving the teams’ efficiency and adherence to study procedures and timelines; Establishing regulatory requirements and site contracts to ensure a smooth start-up process; Liaising and coordinating with Project Manager to facilitate consistent communication for start up. The Site Activation Lead be the team motivator for the Study Start Up team.

    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

    Roles and Responsibilities

    •Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.

    •Attend BID Defence meetings, as directed, to provide strategic study start up advice.

    •Attend Kick Off Meetings, for all assigned studies, to provide strategic input into the study start up discussions

    •Draft CA, EC and contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines.

    •Work with key parties to draft mitigation plans against contractual targets for key milestones.

    •Responsible for the inclusion of the Study Start Up Plan in to the Project Management Plan to be shared and agreed with the sponsor.

    •Fully accountable for the implementation of the Study Start Up Plan for all assigned studies .

    •Responsible for the harmonization of processes and procedures during start up across the region and appropriate training of the team members.

    • In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent “Road Block” situations.

    •Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including

    •Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies in all countries for assigned studies.

    •Accountable for the development, finalisation and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs).

    •Accountable for providing sponsor advice on the content of drug labels including the review and translations of drug labels where costed for.

    •Accountable for ensuring all submission packages receive an independent quality review prior to submission.

    •Accountable for co-ordinating the timely negotiation of contracts and budgets with sites.

    •Accountable for the co-ordination of translations for documents required for submission for assigned studies.

    •Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system.

    •Accountable for the timely follow-up for queries made by CA/EC on assigned studies.

    •Accountable for the collection of critical documents required for IP Release on assigned studies.

    •Where necessary, ensure implementation of an escalation plan as agreed in the study communication plan.

    •Work directly with PM and ICG legal group to establish a defined Clinical Trial Agreement (CTA) process from fallback text to site execution of the CTA. The sponsor may directly be involved in this process or the ICG legal team may discuss directly with the sponsor.

    •Ensure adherence to the SOW and the site activation budget as per the costing model.

    •Manage study resources as appropriate per SOW at any phase of the study. Identify out of scope activities and negotiate changes required to SOW and budget as necessary with the PM.

    •Responsible for establishing format of the standard status report with PM to ensure the sponsor and study management needs are achieved, providing the reports as agreed, to the study management team. •Provide regular communication to the project manager identifying issues/targets/resolutions. Innovate, motivate and empower the site activation team to deliver on the timelines milestones with clear. measurable objectives. Inform site activation Regional/Country Management teams to mitigate risk as appropriate.


    Experience and Qualification

    · Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharmaceutical company.

    · Minimum of 7 Years of experience in a clinical trial lead environment, preferably with Study Start Up Lead experience

    · Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)

    · Good organizational skills and the ability to manage multiple tasks

    · Meticulous attention to detail

    · Good written and verbal communication skills. Proficient in English and language required for country assignments

    · Highly developed problem solving skills

    · Strong people management and effective communication skills

    · Strong project management skills

    · Customer service focused

    · Competent computer skills 


    給与は前職考慮の上で決定いたします

  • 18 Feb 2019

    Study Start Up Associate II

    Japan

    Permanent Position
    ICON - 世界でも5本の指に入るほどの規模と実績を誇るCRO。世界23ヶ国に拠点を持ち、約3600名の社員を抱え、その日本法人である当社は海外オフィスと協力し、海外での治験データを活用して日本での治験を簡略化させる今注目の「ブリッジング」や「グローバル試験」を実践。効率的な治験の実施に向け、戦略的に取り組む製薬メーカー様より大きな信頼を得ています。

    Job Description

    This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Working within a highly qualified team our Study Start up Associates coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate and public sponsored human clinical trials for clinical studies in phases II – IV ensuring adherence to applicable regulations and principles of ICH-GCP

    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

    Key responsibilities:

    •Prepare, review contract negotiation with external sites in Japan, working to project deadline to finalise study contracts

    •You will be collaborating with multiple internal and external teams to coordinate the contract templates and budgets throughout the timeframe

    •Completing contract amendment activities

    •Other study start up activities as required including: ethics submissions, creating submissions packages, amendments to study documentation according to country guidelines in Japan



    給与は前職考慮の上で決定いたします

  • 18 Feb 2019

    Senior Clinical Trial Manager

    Japan

    Permanent Position
    ICON - 世界でも5本の指に入るほどの規模と実績を誇るCRO。世界23ヶ国に拠点を持ち、約3600名の社員を抱え、その日本法人である当社は海外オフィスと協力し、海外での治験データを活用して日本での治験を簡略化させる今注目の「ブリッジング」や「グローバル試験」を実践。効率的な治験の実施に向け、戦略的に取り組む製薬メーカー様より大きな信頼を得ています。

    Job Description

    Overview of the role
    •Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients

    •Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects

    •Contribute to the development and maintenance of cross functional project management plans

    •Responsible for risk mitigation strategies, associated action plan and issue resolution

    •Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff

    •Provide direction and support to the Clinical Operations study team

    •Collaborate with Business Development (BD) to ensure timely completion of change orders

    •Track Clinical Operations project deliverables using appropriate tools

    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

    Role Requirements
    •A satisfactory progression of monitoring experience, along with previous experience in leadership and/or management activities

    •Previous working experience within the clinical trial management field.

    •Business level in written and spoken English.

  • 18 Feb 2019

    CRA Ⅱ

    Japan

    Permanent Position
    ICON - 世界でも5本の指に入るほどの規模と実績を誇るCRO。世界23ヶ国に拠点を持ち、約3600名の社員を抱え、その日本法人である当社は海外オフィスと協力し、海外での治験データを活用して日本での治験を簡略化させる今注目の「ブリッジング」や「グローバル試験」を実践。効率的な治験の実施に向け、戦略的に取り組む製薬メーカー様より大きな信頼を得ています。

    Job Description

    【Overview of the Role】

    •Working independently and proactively to coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested

    •Managing sponsor generated queries efficiently and taking responsibility for study cost effectiveness; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. 

    •Depending on your level of experience, you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects

    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)】

    Role Requirements 
    •With a University degree in medicine, science, or equivalent; you will have previous monitoring experience in medium sized studies, including study start-up and close-out (for all roles above Entry Level). You should also have knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data

    •You will possess excellent written and verbal communication (Japanese language) and interpersonal skills enabling you to deal with queries in a timely manner. You should be able to produce accurate work to tight deadlines within a pressurised environment

    •You must be available to travel at least 60% of the time.

    •You will have the opportunity to progress your career and may wish to move into Project Management or into other related areas where you can further develop your skill set.


    給与は前職考慮の上で決定いたします

  • 18 Feb 2019

    Senior CRA

    Japan

    Permanent Position
    ICON - 世界でも5本の指に入るほどの規模と実績を誇るCRO。世界23ヶ国に拠点を持ち、約3600名の社員を抱え、その日本法人である当社は海外オフィスと協力し、海外での治験データを活用して日本での治験を簡略化させる今注目の「ブリッジング」や「グローバル試験」を実践。効率的な治験の実施に向け、戦略的に取り組む製薬メーカー様より大きな信頼を得ています。

    Job Description

    Role Responsibility
    1.Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in phases II – III ensuring that applicable regulations and principles of ICG-GCP are adhered to 

    2.Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation 

    3.Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested 

    4.Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required 

    5.Managing sponsor generated queries efficiently and responsible for study cost effectiveness 

    6.Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects

    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)】

    Experience and Qualification 
    1.1+ years of monitoring experience in phase I~III trials as a CRA 
    2.Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data 
    3.Native Japanese level and conversational English at least 
    4.Excellent communication and interpersonal skills, both written and verbal enabling you to deal 

    給与は前職考慮の上で決定いたします

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