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427 listing(s) available.

  • 05 Mar 2019

    MSL 免疫領域 MSL Immunology

    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 担当疾患領域におけるIBPに基づく科学的な課題をサイエンティフィックエクスチェンジを通して解決し製品価値の最大化に貢献する
    To maximize product value through scientific exchange via achieving scientific objective in the responsible therapeutic area based on IBP(Integrated Brand Plan) 

    2 担当疾患領域におけるEE/その他医療関係者からの研究サポートや医学的・科学的ニーズを満たすための情報を提供する
    To provide information to meet medical, scientific needs and research support from EE(External Expats) / other medical personnel in the responsible therapeutic area 

    【Accountabilities】& 【Related Performace Indicators】 
    1 IBP/ICP/ICEに基づく活動計画の立案
    To build activity plan based on IBP/ICP/ICE
    (Integrated Brand Pklan/Integrated Customer Plan/Integrated Customer Engagement)

    ・担当疾患領域におけるEEを特定し、適切に改訂する
    To identify EE in the responsible therapeutic area and revise list accordingly

    ・担当疾患領域におけるIBP/ICP/ICEに基づく適切なEE engagement planを策定する
    To develop appropriate EE engagement plan based on IBP / TA strategy in the responsible therapeutic area 


    2 IBP/ICP/ICEと一貫したEE engagement planの実行及びその記録
    To record and excute EE engagement plan aligned with IBP/ICP/ICE

    ・EEから担当製品に関するサイエンティフィックインサイトを得るために、SI(Scientific Interview)/Scientific exchangeを実施する。また、そのための適切なコンテンツを作成する。また、学会等からの最新情報も含め得られたサイエンティフィックインサイトは戦略やアクションプランの策定のために関連部門と共有する 
    To conduct SI/Scientific Exchange in order to gain scientific insight on responsible product from EE and to create appropriate contents. Also, to share scientific insight including latest information from congress, etc. with relevant departments to develop strategies and action plans

    ・ 担当疾患領域で企画、実施するアドバイザリボード組織化をサポートし、サイエンティフィックミーティングを企画・実施する。
    To support planning and organization of advisory board for execution in the responsible therapeutic area as well as planning and implementation of scientific meetings

    ・ ターゲットEEに対し定期的なコンタクト/コミュニケーションをとり、製品ライフサイクルを通じて良好な関係構築・維持する。
    To build and sustain positive relations with target EE throughout product life cycle via regular contact and communication

    ・ 顧客との関係構築においてデジタルツールを活用する。
    To utilize digital tools in customer engagement

    ・ 当該活動全般における記録及び予算管理を行う。
    To manage budget and leave record for responsible activities as a whole 


    3 データ構築及びIIS(Investigator Initiated Studies) の支援
    To provide support for IIS and data building 

    ・データギャップやアンメットニーズを埋めるために、実現可能性、科学的適切性、倫理性を考慮した新たな科学的データを創出する
    To create new scientific data in consideration of feasibility, scientific appropriateness and ethics in order to fill data gap and unmet needs

    ・要望に応じた臨床/非臨床のIISをリエゾンとしてサポートする
    Support clinical/non-clinical IIS as liaison based on request 


    4 顧客からの要望に応じた承認/未承認/適応外の科学的情報の提供
    To provide scientific data on approved/unapproved/off-label products based on customer's request

    ・EEその他医療関係者からの科学的質問、要望に応じた適切なコンテンツを作成し、担当疾患領域内で承認を得た上で適切に情報提供を行う。To create appropriate contents based on request and scientiic question from EE and other medical personnel as well as to provide appropriate information on top of full approval within responsible therapeutic area 

    ・要望に応じて、研究結果やデータスライドを講演会演者や演者候補者に提供する
    To provide research result data slide to speakers as well as to speaker candidates based on request

    ・要望に応じて、スピーカートレーニングの会合に参加し、科学的なコンテンツのトレーニングを実施または質問に回答する
    To attend speaker trainings to conduct scientific contents training and to answer questions based on request 


    5 MRトレーニング MR Training 

    ・MRの知識レベルを向上するため、研修部門からの要望に応じて、MRトレーニングを実施する
    To conduct MR training in order to improve knowledge level of MR, based on request from training department 


    6 行動規範・法令の順守 To comply with Code of Conduct / Laws and Regulations 

    ・ 法規制や業界ルール(プロモーションコード、公正競争規約、個人情報、データ収集/保管など)、関連SOPを理解し、遵守する。
    To understand and comply with regulations and industry rules (promotional codes, fair competition rules, privacy, data collection/storage, etc.) as well as related SOP

    ・ 社員の自覚を持ち、社会規範、社内行動規範則って行動する。
    To act according to social norms and company's code of conduct with full awareness as a responsible NBI employee 

    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

    MSLグループは担当領域のメディカルプランの実行に注力し,外部顧客のエンゲージメント活動を推進しています。

    疾患領域の専門家の先生方から,上市後の適正使用推進に役立てるinsightを得るScientific interview/ Scientific exchange 活動を実行しています。また,特定の医師とのコミュニケーション,アドバイザリーボード会議,公表論文等から,自発的,継続的にプロダクトのアンメットメディカルニーズを探求することが求められます。将来のメディカルアクティビティの立案に必要な情報を集約し,外部のステークホルダーとの協働により長期的な視野を持ってプロジェクトの計画ができる人材を求めています。
     

  • 05 Mar 2019

    医薬開発本部CRAサイトマネジメント/CRA Site Management COJ Medicine

    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

    As a member of trial team, provide and maintain oversight and guidance related to site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.

    Provide operational expertise to the trial team on the site monitoring approach for the trial. Oversee the implementation of the site monitoring approach to ensure trials are monitored based on SOPs, relevant regulations.


    Regulatory and / or Organisational Requirements


    Ensures all tasks are carried out in accordance with respective applicable Standard Operating Procedures (SOPs), processes and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with values. 

    Job Complexity

    Works within a complex Good Clinical Practice (GCP) and regulatory environment and on global clinical trials with multi-disciplinary, international teams and with various internal and external stakeholders including vendors and investigational sites.

    Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on the reputation of company with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative methods as working group member 

    Interfaces*

    Functional leadership role within a clinical trial with no direct report. Liaises and partners with multi-disciplinary, international teams and both internal (i.e. functions inside and outside of Medicine) and external stakeholders (including vendors, investigators and site teams, clinic/hospital representatives, regulatory authorities/inspectors) in the context of clinical trials. 

    Job Expertise

    Proven track-record of solid site monitoring experience covering at a minimum 4 years of CRA experience and all stages of clinical trials (i.e. site selection, initiation, conduct and close-out). trial management experience is a plus


    In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) and understanding of legal/regulatory environment as it pertains to major regulatory authorities and relevant directives/regulations.


    Solid project management and internal/external communication skills.


    Job Impact

    Functionally responsible for the site monitoring approach, processes and oversight for global clinical trials for products in clinical development or post approval to ensure that robust and quality data is collected that support registration of products. Site monitoring has a significant impact on the budget and regulatory assessment of a clinical trial. 


    Accountabilities * Related performance indicators

    Trial Preparation:
    Deliver site monitoring approach for the trial when assigned:

    • Develop Trial Level Monitoring Manual and provide related input into trial plans, processes (e.g. trial risk assessment, Trial ISF/TMF, IMP management, Supplier selection such as central imaging or laboratory) and documentation (e.g. input into CTP, IQRMP, IC and develop SFQ and other relevant site logs/ forms such as source data status report, etc.).

    Deliver site monitoring oversight plan for the trial:

    • Develop Site monitoring oversight plan and provide


    Completeness and quality of the assigned documents.

    related input into trial level supplier oversight plan. in a trial, when assigned Ensure appropriate training: 

    • Provide input into trial training plan and develop and deliver trial-specific training for Clinical Research Associates (CRAs). 
    Support streamlined data collection: 
    • Provide input into eCRF 
    • Support development of checklists/templates (as appropriate) and support IRT set-up (input into IRT requirements/set-up and conduct UAT) 
    • Participate as appropriate in trial team meetings, International/regional investigator meetings and Drug supply meetings 
    Facilitate communication with Clinical Trial Managers (CTMs) and CRAs.

    Trial Conduct:

    Oversee site monitoring activities in the trial:
    •Issue management / oversight on trial level: review and assess site issues, escalate to CTL as appropriate, prepare for trial oversight/MQR meetings and follow up on further actions with countries when applicable
    •Pre-identify important protocol deviations from site issues/deviations for CTL(and TSTAT)or TCM to take final decision.
    •Pro-active risk mitigation: perform regular risk indicator review as applicable and determine and follow up on required actions
    •Maintain site monitoring approach for the trial and update Trial Level Monitoring Manual, site monitoring oversight plan and other core trial documents such as ISF templates etc. as required
    •Conduct process and site quality performance monitoring and checkpoint calls or visits with the CRAs in a trial according to the site monitoring oversight plan, implement follow-up actions and escalation as required

    Facilitate communication and training related to site monitoring in the trial:
    •Communication with CTMs, CRAs, perform re-training etc.
    •Participate, prepare input and (co-)lead trial oversight meetings

    A final Trial Level Monitoring Manual prior to the first Site Initiation Visit in a trial when assigned

    A final site monitoring oversight plan prior to the first Site Initiation Visit 

    Timely update of the trial level monitoring manual when assigned, site monitoring oversight plan and other core documents.

    No critical findings in audits and inspections regarding completeness and quality of the assigned documents.

    Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders. 

    Trial Close-out:

    Coordinate DBL planning with Trial Team and countries.

    Support compilation and review of the quality section for the clinical trial report for site monitoring activities.

    Facilitate communication:
    •With CTMs and CRAs

    Adherence to all timelines.

    Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders. 

    Liaison with relevant functions within COJ to oversee document translation process within COJ, including but not limited to:
    •delivery of document translation by external vendor
    •Arrange review of translated documents and ensure quality.

    Timeliness of document translation. Quality of translated document. 

    Act as a trial monitor to perform monitoring activities if assigned per SOPs, applicable international and Japanese regulations / guidelines 

    Management and Relationship Responsibilities:

    Adhere to international, local and internal requirements in the planning, conduct and reporting of clinical trials. 

    Conducts work in a professional manner as evidenced by feedback from internal and external stakeholders. 

    Support the development of company relationships with opinion leaders and set up good working relationship with investigational site staff, internal staff, Vendors. 

    Proactive behavior. 

    Participate in working groups related to site monitoring.

    Management and Relationship Responsibilities:

    Adhere to international, local and internal requirements in the planning, conduct and reporting of clinical trials. 

    as a member of COJ, participate and contribute to different initiatives within COJ to achieve its vision, and priorities

    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

    Minimum Education/Degree Requirements*

    University degree in life sciences or related field OR

    equivalent professional education may be acceptable if complemented by solid work experience as CRA.


    Required Capabilities (Skills, Experience, Competencies)*

    Agility:

    Coordination and oversight; setting priorities, processing and analyzing data and information

    Achievement and performance driven


    Accountability:

    Deciding, problem solving, independence

    Communication, cultural sensitivity, clear and transparent, internal and external focus, collaboration and team work


    Intrapreneurship:

    Digital solutions for trial management Driven to learn and grow


    Solid knowledge in and experience with site monitoring processes and expertise with relevant tools and systems (e.g. Electronic Data Capture (EDC), Site Management System (SMS)).


    Capable of performing site monitoring activities (CRA responsibility) at any stage of a clinical trial if required


    computer skills:

    Excel, Word, Outlook, Powerpoint, Internet and Boehringer Ingelheim systems

    Language:

    fluent in verbal, and written communication English 

  • 04 Mar 2019

    Digital Performance Section Head

    Singapore

    Permanent Position
    A first tier Composite Insurer located in the Heart of the Central Business District is seeking a Digital Performance Section Head to foster collaboration between stakeholders and provide leadership to strengthen digital performance marketing. Moreover, you will be driving the digital marketing strategy implementation of the various campaigns across the region. You will also be responsible for coordinating digital activities, reporting on results, optimising and driving digital adoption and engagements. In return, this is an unique opportunity where you will get to manage the performance team and provide coaching/mentoring for career growths of the individuals in your team.

    Job Description

    • Develop digital integrated marketing and communications plan with specific goals and budgets;
    • Develop always on digital marketing strategy that resonates with our audiences to drive brand preference, brand amplification and lead generation;
    • Collaborate with Business units to support regional digital/brand efforts and drive digital excellence, efficiencies and prioritized planning for adaptation at the regional/local level in alignment with strategy and roadmap;
    • Oversee campaign launches and measurement planning inclusive of data capture strategy, measurement, optimisation plans and assuring proper tagging and trafficking of new media activities that are executed by our agency;
    • Exploring new and unique opportunities to reach customers via emerging channels and push the limits on emerging technology – as applicable to the business;
    Expires on 29 Mar 2019

    Posted By

    Lin Wee

    Tel: 65113424

    linwee@peoplesearch.jobs

    Requirements

    • 8-10 years’ experience in digital marketing;
    • Has proven track record of success in achieving business goals and objectives;
    • Bachelor’s degree in Business, Marketing, or related field;
    • Proven track record in managing agency partners and 3rd party tech vendors;
    • Proven understanding of digital platforms, technologies, data & analytics;
    • Expert knowledge, skills and demonstrated track record across a range of functions including digital, brand, analytics and performance marketing;
    • Comprehensive understanding of the digital ecosystem and how the various channels work together to optimise behaviour and acquisition, as required;
    • Familiarity of segmentation, analytics and direct experience with web measurement/analytics is preferred;

     

    If you meet the above requirements strictly, please send your most updated resume to linwee@pplesearch.com. For clarifications beyond the above information, please call Lin Wee at 6511 3424 (Reg No. 16S8057)

  • 04 Mar 2019

    R&D Firmware Team Leader – Global MNC

    Singapore

    Permanent Position
    A global organization is looking for a R&D Firmware Team Leader to lead the firmware development team and firmware functional test team to carry out development activities. You will be responsible to utilize product domain knowledge and sound engineering practices where you will do technical activities in parallel with management activities.

    Job Description

    • Oversee multiple projects and ensuring the right firmware architectural design, test coverage, set of skills, equipment and strategy
    • Develop and execute together with the team
    • Manage KPIs and target deliverables for the group
    • Tracked project executions and monitor issues/progress
    • Work out issues and challenges together with team
    • Track qualities and project maturity
    • Perform analysis and improvement on the existing activities
    • Participate in reviews for feature requirements and design
    Expires on 03 Apr 2019

    Posted By

    Michael Ng Kheng Loong, Huang Qingliang (Reg No: R1653938)

    Tel: +65 6738 6228

    michaelng@peoplesearch.jobs

    Requirements

    • Degree in Computer Science, Computer/Electrical/Electronic Engineering or related fields
    • Minimum 2 years of experience in people management or leading experience (with team bigger than 3 peoples)
    • Minimum 5 years of experience in test and firmware development (especially Real Time Embedded Systems)
    • Strong experience with programming 32 bits Microcontroller ( ARM or ColdFire ) and developing low level device driver
    • Background in developing RTOS, such as VxWorks, ThreadX or others and communication protocols like Ethernet/USB/WIFI and CAN/Profibus
    • Strong knowledge and foundation about testing and software design life cycle whether it is in AGILE or Waterfall environment.
    • Detailed, good analytical and troubleshooting skills are required
    • Strong communication and interpersonal skills are required
    • Open-minded, a willingness to experiment within acceptable boundaries and a creative mind to bring novel solutions into design and problem-solving

    Office Location: West
    Kindly indicate your current/last salary details and your notice period

    Interested candidates kindly forward your CV to michaelng@peoplesearch.jobs (Michael Ng Kheng Loong, Huang Qingliang, Reg No: R1653938)
    Feel free to forward this great opportunity to someone who would be a great fit for this role.

    All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.

    PeopleSearch Pte Ltd
    EA License No: 16S8057

  • 04 Mar 2019

    フロントマネージャー

    Japan

    Permanent Position
    大手日系新規開業ホテル

    Job Description

    • フロント部門全般のマネジメント 
    • ブランドスタンダードに相応しいサービストレーニングや労務管理
    • 部門予算の作成並びに収益達成に向けた取り組み
    Expires on 03 Apr 2019

    Posted By

    Maiki Kono

    Tel: +81 80-1118-4564

    kono.m@pplesearch.com

    Requirements

    • 英語必須
    • ホテル実務経験最の方
    • フロントオフィスでのスーパーバイザー又はマネジメントと実務経験最の方
  • 04 Mar 2019

    クラブラウンジマネージャー・Club Lounge Manager

    Japan

    Permanent Position
    東京都内五つ星日系ホテル・5 Star Japanese Hotel Tokyo

    Job Description

    • 世界中からのクラブフロア・VIPゲストの滞在をより快適にする
    • 五つ星ホテルに相応しいサービスを提供する為のスタッフ管理や育成
    Expires on 03 Apr 2019

    Posted By

    Maiki Kono

    Tel: +81 80-1118-4564

    kono.m@pplesearch.com

    Requirements

    • 英語と落ち着きのある応対
    • VIP対応経験に富んでいる
    • リーダーシップ、チームワークを発揮できる方

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