【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 08月 23日

会社概要

生産性の高さで世界中から注目、バイオ医薬品企業

設立年
2012年 
本社所在地
東京都 
事業内容
医薬品・医療機器の輸入、販売、研究開発、マーケティング事業 

この会社の求人情報

5件中1~5件を表示しています。

求人管理No.011154

Market Research Manager/Senior Manager

外資製薬メーカーにてマーケットリサーチプロジェクトにおける戦略的な分析

Market Research Manager/Senior Manager

募集要項
社内ブランディングチームと連携し、マーケットリサーチプロジェクト
の適切な方法論を定義した上で、戦略的な分析を行う。

・複数のプロジェクトの戦略的な分析と計画
・製品ライフサイクルチームの一員として、
 ブランドプロモーション計画のための調査戦略立案と実行
・調査会社の選定やマネジメント
・予算やスケジュール管理
・JPM、JDI、DDD、ScripTracなどの2次的研究データの分析 など 
募集条件
【必須】
・製薬業界関連の市場調査経験を5年以上お持ちの方
・ビジネスレベル以上の英語力 
勤務地
東京

求人管理No.010879

Clinical Research Scientist

Clinical Research Scientist

Clinical Research Scientist

募集要項
Reporting to the Head of Clinical Research Japan, the Clinical Research Scientist (CRS) plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for development compounds.
Although generally assigned to a specific therapeutic area, the CRS may support local clinical research activities across development programs. The overall responsibilities of the CRS include the following:
・Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.
・Provides scientific support to functions including but not limited to GSI Clinical Research, Clinical Operations, Biostatistics, Data Management, Medical Writing and Medical Affairs.
Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner
・Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support development programs.
・Responsible for the design of Japanese clinical research studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols
・Prepares and presents (if applicable) scientific information concerning development programs internally and at external meetings as required.
Responsible for drafting regulatory Briefing Documents and slide presentations for use at
・PMDA and MHLW meetings. Attends and presents position at informal and official Consultation meetings with PMDA and MHLW
・Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries. 
募集条件
・MS degree or above.
・Minimum of 5 years of experience within clinical research in the pharmaceutical industry.
Experience in cardiovascular area is preferable (not mandatory).
・Experience in preparation for and attendance at PMDA/MHLW consultation meetings.
・Direct experience in the preparation and filing of CTNs, J-NDAs and other clinical research
documentation.
・Current, working knowledge of ICH and local guidelines and PMDA/MHLW notifications.
・Good communication and discussion skills to build and maintain working relationships with
Japanese physician and research scientists.
・Strong organizational skills and ability to manage multiple projects simultaneously.
・Fluency in oral and written English. 
勤務地
東京

求人管理No.009577

Medical Scientist

Responds to clinical inquiries regarding marketed or developmental products.

Medical Scientist

募集要項
・Responds to clinical inquiries regarding marketed or developmental products.
・Presents scientific and clinical data for these products.
・Identifies and develops regional and national opinion leaders to support products and trains approved speakers through personal contacts and on-site visits.
・Establishes strong relationships with opinion leaders, clinical investigators and providers at academic and non-academic settings.
・Assists with sales force training at national and regional levels.
・Assists with Phase IV program that includes collaboration with investigators and internal personnel.
・Assists with site selection for both Phase IV and other clinical trials.
・Anticipates obstacles and difficulties that may arise in the field and resolves them in a collaborative manner.
・Works collaboratively with personnel in Sales, Marketing, Clinical Research, Global Safety and Medical Communication.
・Sought for advice and collaboration within and outside.

・Utilizes scientific resources to deliver impactful presentations in a variety of different settings.
・Travels to appointments, meetings and conferences on a frequent and regular basis, occasionally with short notice.
・Must be fully cognizant of all relevant scientific data and regulatory requirements for field-based personnel.
・Must be committed to continuing education to maintain knowledge base.
・Must have the ability to work as a member of several teams that may overlap such as national MS team, regional sales team, national accounts, and others.
・Utilizes scientific resources for impactful presentations in a variety of different settings.  
募集条件
・Advanced degree (i.e. MD, DO, PharmD, PhD, Nurse Practitioner or Physician Assistant) preferred or may have a BS in pharmacy or BS/MS nursing with extensive clinical and/or industry experience.
・Relevant experience must include at least 3 yrs clinical practice experience in hepatology, viral hepatitis, HIV or infectious diseases.
・Pharmaceutical industry experience desirable.
・Excellent verbal, written, and interpersonal communication skills are required in both Japanese and English.
・Experience in preparing and delivering presentations is required.
・Experience in the management or investigation of clinical trials is highly desirable.
・Clinical patient contact experience is highly desirable. 
勤務地
東京

求人管理No.009002

Drug Safety, Associate Director / Senior Manager

Create strategy to manage safety information in Japan and outside Japan in close collaboration with the drug safety

Drug Safety, Associate Director / Senior Manager

募集要項
・In close communication and collaboration with the headquarters, the drug safety
director / associate director / senior manager has a full responsibility of case
management and safety reporting as well as planning and managing post-marketing
safety surveillance. Primary responsibilities are as follow:
・Create strategy to manage safety information in Japan and outside Japan in
close collaboration with the drug safety.
・Oversee the tasks of CROs for safety case management and solve any
problems ensuring to meet timelines and milestones.
・Lead the preparation of any safety reporting.
・Ensure the safety reporting to PMDA in a timely manner.
・Plan and manage the risk management plan for J-NDA.
・Negotiate with the PMDA on the language on safety in the Japanese label.
・Oversee the execution of the post-marketing surveillance.
・Directs development of SOPs within department. 
募集条件
・Experiences in drug safety/PMS in at least 10 years.
・Experiences in selection and oversight of CROs and vendors.
・Experiences in case management and preparations of safety reports.
・Experiences in PMS planning and execution.
・Strong familiarity with ICH/local guidelines and PMDA/MHLW notifications.
・Good skills of communication in Japanese and English (>730 TOEIC)
・Must have demonstrated organizational skills to manage multiple projects
simultaneously.

・Experiences in liver disease or oncology area are preferred.
・Registered Pharmacist is preferred. 
勤務地
東京

求人管理No.008468

Regulatory Affairs(オンコロジー)

臨床開発、J-NDA申請など薬価戦略など薬事業務

Regulatory Affairs(オンコロジー)

募集要項
・米国とのコミュニケーション・調整
・PMDAとの調整
・新薬の海外動向などの調査
・臨床開発、J-NDA申請など薬価戦略
・CTD等の薬事資料の策定と提出
・ライセンスを維持
・CROやベンダーとのリレーションシップ
・CROコントロール
・PMDAと厚生労働省との良好な関係を確立します。
・部門内SOPの開発を指示します。 
募集条件
・10年の薬事経験
・CROやベンダーの管理経験
・J-NDAのための文書経験
・ICH/ローカルガイドラインとPMDA/厚生労働省の関係構築
・TOEIC730点以上
・肝疾患、または癌領域の経験が好ましい
・薬剤師、博士取得された方は歓迎 
勤務地
東京

5件中1~5件を表示しています。