Work Schedule Other Environmental Conditions Office Job Description At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to
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
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world
DESCRIPTION Overview This role is for an EHS Manager, Safety Specialist or Safety Engineer. The roles prime responsibility will be to support the safety operations in Tokyo, Japan. As well as this, there may be opportunities
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description commercial organisation driving revenue growth within our division. You will also influence other functions, including product management, solutions development, and services, to ensure we meet our yearly
* Lead and project management of the following studies: - CSS (Company-led research) - IIS (Doctor-led research) - Collaborative study - Including oversight of external CRO Client Details * Leading global CRO business, with rich project
Lead in GQP QA operational activities for the business for company products. Ensure effective compliance, continuous improvement activities, and overall quality processes. Client Details * Global Pharmaceutical company specializing in generics, biosimiilars, APIs, and new products for
* 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 *
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
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
An exciting opportunity as an Operation Specialist at a leading global logistics company. Some of the responsibilities involve order processing of Shippers Own Tanks (Round-Trip Operations) and handling of import and export orders for local customers.
* The Safety Management Officer will oversee all safety management and pharmacovigilance (PV) activities in Japan. * This role involves ensuring compliance with local regulations, managing risk, and maintaining high standards of safety for all products.
Drive Business Development activities such as seed and financial evaluation, seeking for potential partnering opportunities, negotiation, and alliance management. Client Details Our client is global Pharmaceutical company with great pip line. The company are planning to launch
* We are seeking a fluent Japanese and business-level English-speaking EDC System Implementation Specialist with clinical programming expertise to join our biometrics specialized CRO client, partnering with Japanese pharmaceutical companies. This remote role offers a competitive salary
Take lead in CMC RA activities for the business in regulatory strategy/maintenance to obtain and maintain regulatory approval. Contribute and support the CMC RA organization both domestically and overseas members Client Details * Global Pharmaceutical company specializing
Drive portfolio strategy. Ensure team is performing to win the market. Client Details Our client is global pharmaceutical company. The company has very rich pipeline and planning to launch numbers of new products to Japan market. Description
* Develop and monitor annual business plans and objectives, providing updates and resolving issues in collaboration with senior management and stakeholders and Japan GM. * Execute business plans, coordinating review meetings and managing cross-functional projects while
Drive collaboration for commercial and legal/compliance team to ensure that lectures, conferences, promotional and informational activities, and promotional materials are complied and use as appropriate. Client Details Our client is global Pharmaceutical company. The company has rich
This role entails aiding in the execution of clinical trials in new therapy areas, offering medical insights from engagements with key opinion leaders and professional associations, while reporting to a lead within the team overseeing these
Take lead in quality activities to ensure effective compliance. Manage QMS and other quality claims. Client Details * Global pharmaceutical company specializing in innovative treatment for oncology, urology, and auto-immune areas. * Rich development pipeline for new
