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
Microsoft Cloud Operations + Innovation (CO+I) is the team behind the cloud. CO+I is responsible for delivering over 200 Microsoft web portals, Live and Online Services around the world including infrastructure, security and compliance, operations, globalization,
Job Description Summary of job scope: We are seeking a Machine Learning Engineering Paid Internship, with a growth mindset, to work closely with cross-functional business teams adopting agile ways of working, to create business values and
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
Job Description Our Company is a biopharmaceutical company with a mission of discovering, developing, and delivering innovative medicines and vaccines which save and improve peoples’ lives. We have opened two roles in our Customer and strategy
■ Job Description / Capsule Responsible for new product planning and life cycle management of existing products pipeline to maximize its opportunity/value and contribute to pursue R&I vision “Be the indispensable partner in transforming patient life
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical
About ERM Sustainabilityis our business. As the largest global pure play sustainability consultancy, ERM partners with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today
Job Description Summary ・Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic
■ 職務内容 / Job Description Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in
Job Description Summary Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic
Job Description Summary Drive marketing excellence through developing marketing capabilities in our organization and leading strategic framework process and governance. Develop industry-leading marketers who can thrive in an ever-changing external environment through comprehensive training programs. Promote strategic
Job Description Summary Role Purpose: The Lead, TA Medical or Associate, TA Medical is accountable for building responsible brand or disease area medical strategy and ensuring its execution in collaboration with MSLs, MSEs and other partners
■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate
Job Description Associate Director, Vaccine Marketing Join our dynamic Vaccine Marketing Unit, where we collaborate with senior management and cross-functional teams to tackle critical public health challenges in Japan. Our goal is to ambitiously embark on
The Field Account Manager will be responsible for revenue growth within an assigned group of accounts, proactively selling the full range of the BioProcess portfolio, and developing strong customer relationships in order to leverage our position
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Job Description Expert Associate Director, Vaccine Marketing, title: Product Owner Join our dynamic Vaccine Marketing Unit, where we collaborate with senior management and cross-functional teams to manage the project to successfully launch a completely new concept
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’
■ 職務内容 / Job Description SFCEの一員として将来の重要な戦略と方向性の決定並びにアストラゼネカジャパンの営業組織を含むプロモーション実施体制決定をサポートします 事業部長、Marketingや営業部門等のステークホルダーに対し各種分析や戦略を提案並びに効果的な情報やツールを提供ることにより、ブランド価値最大化、販売目標達成に貢献します 主な役割としては、以下のようなものがあります： - 営業組織を含むコマーシャルモデル設計 - Segmentation & Targeting - KPI目標値設定とモニタリング - 営業賞与プランの設計並びに賞与支払の計算 - AIを活用したChannel-mixのプロモーション活動プランの作成 - 営業テリトリーデザイン - シニアリーダーへの提案と結論に至るまでのプレゼンテーション/ファシリテーション - 各製品のクロスファンクションチームに、SFCE代表として参加 - 営業マネージャー/営業推進部との協業による営業計画推進のサポート As a member of the SFCE Department, you
