Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年） ・GVP対応（情報収集、当局報告、記録書作成保管等） ・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等） ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬事規制（特に安全管理業務）に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Are you an ambitious and proven business development executive with a passion for driving growth? Thermo Fisher Scientific Inc. is seeking a Sr. Business Development Executive -
Join an innovative biopharmaceutical company dedicated to pioneering advancements in healthcare. Our client is seeking a dynamic and experienced Cardiovascular Product Manager to lead our in developing and executing marketing strategies for their new cardiovascular product
* Develop and implement strategic marketing plans for cardiovascular products, leveraging market insights and cross-functional collaboration. * Drive product success through comprehensive market analysis, strategic partnerships, and innovative approaches to enhance market position. Client Details * Our client
As a B2B Sales Manager, you will be responsible for developing and maintaining strong relationships with business clients, identifying new sales opportunities, and driving revenue growth. Your role will involve understanding client needs, negotiating contracts, and
As an Inside Sales Manager, you will be working in close collaboration with the sales team and existing customers in the automotive industry to nurture the business relations. Your role involves proactively communicating with the stakeholders and
* Create and lead Evidence Generation Plan * X-functional position understanding strategies of Medical / Commercial / R&D Client Details * Global pharmaceutical company * Pioneer and Leader in RWE, observational research study design and execution Description
As a clinical trial manager, you oversee the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements while collaborating closely with cross-functional teams to drive successful trial completion and contribute to
This is a leading start-up fintech company based in Tokyo Responsibilities: 1 Team Leadership: Lead and mentor a team of UX designers, providing guidance, feedback, and support to foster a culture of collaboration, creativity, and excellence. 2
You will play a critical role in bridging the communication gap between Japan and the regional/global teams. Manage a small team. If you are looking to focus on management rather than a technical position this role
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
After 10 years of continuous growth, Janssen Japan (JPKK) business is faced with two years of solid growth in 2024 and 2025. This is an important period to ensure successful delivery of our performance goals. As
Who we are About Stripe Stripe is a financial infrastructure platform for businesses. Millions of companies—from the world’s largest enterprises to the most ambitious startups—use Stripe to accept payments, grow their revenue, and accelerate new business
This position requires English language ability. JD is available in English only. 本ポジションは日本語JDの用意がありません。 Introduction Circulate all forms of value to unleash the potential in all people What can I do to help society thrive with the
Woven by Toyota is the mobility technology subsidiary of Toyota Motor Corporation. Our mission is to deliver safe, intelligent, human-centered mobility for all. Through our Arene mobility software platform, safety-first automated driving technology and Toyota Woven
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
Job Description As E-commerce Key Account Manager (Japan), you will drive operational excellence and seamless customer experience on digital marketplace platform while consistently maintaining the H&M brand. The role will work collaboratively and cross-functionally to drive and
Reporting to the Business Insights & Analytics (BI&A) Center of Excellence (CoE), APAC, you will make a significant impact in Johnson and Johnson Innovative medicines Japan to drive market leading, insight led competitiveness. You will lead
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
