Job Description About This Role This role is serving as IT focal point for Japan R&D, acting as IT Business Analyst, affiliate level of IT project manager and supporting Japan R&D members for any kinds of IT
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
職務の目的 規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行し、承認前GMP適合性調査、定期的なGMP適合性調査及び外国製造業者認定の新規取得/管理を確実に行う。 主な業務内容 下記業務における規制当局窓口業務(申請・照会事項対応) 新薬申請時の承認前GMP適合性調査 一部変更承認申請時の承認前GMP適合性調査 定期GMP適合性調査 外国製造業者認定 新規申請・更新・変更 必要な条件 海外と口頭でコミュニケーションができる最低限の英語力(リスニング、スピーキング)(TOEIC600点~) 社内関連部署及び当局と交渉するためのコミュニケーション能力 スケジュール管理能力 製薬業における業務経験 リーダーシップ 望ましい条件 高度な英語力(TOEIC700点~) 医薬品製造・品質保証に関する知識・経験 医薬品製造販売承認申請書に関する知識・経験 GMPに関する知識・経験 ピープルマネジメントの経験 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is
About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
Basic purpose of the job The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include: An integral member of the Regulatory Excellence Team,
The Head of Government Affairs – East Asia (EA) is responsible for Nokia’s engagements and advocacy activities towards state and local governments and key industry groups throughout the East Asia region. This includes Japan, South Korea and
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
Career CategoryRegulatory Job Description Group Purpose Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and
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Career Category Scientific Job Description Position Summary: The Manager will serve as a customer facing field medical lead to the medical/scientific community and will be responsible for establishing, developing and maintaining engagements and collaborations with prominent experts
Objectives of the Position As expert in corporate Environment, Health and Safety, assist Business Units in improving and maintaining EHS performance of BASF Japan (BJL) and group companies located in Japan. Applicable subject matters (not necessary
Leads and implements the Health Care Compliance (HCC) program locally under supervision of the HCC Officer of MedTech Japan to ensure business practices and activities follow related J&J internal guidelines, local laws and regulations and anti-corruption
Basic purpose of the job - Lead/Manage GPSP activities such as planning post marketing surveillance studies as additional PV plan based on safety specification in compliance with GVP and GPSP regulations, lead vendor management, Reexamination and
The Sales Manager will lead the launch and market expansion of a transformative gene therapy product in Japan. They will develop strategic sales plans, lead a high-performing team, and build key relationships to drive product adoption. Client
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
Basic purpose of the job Insight Analyst is responsible for supporting therapeutic area teams with medical insight management. The role involves ensuring proper recording of scientific insights, resolving technical issues with insight capturing platforms, and analyzing
( Innovative Medicine ) TA Specialist /Manager , Lung Cancer , Oncology , Medical Affairs The TA Specialist or Manager of Medical Affairs, Lung Cancer will be responsible for conducting Medical Affairs activities for the J &J solid tumors products primarily
ERM is looking to recruit an experienced regulatory affairs professional with experience with Crop Protection regulations to join our Sustainable Products and Supply Chain (SP&SC) team. This role would be based in the Japan. The role We have