SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle align ed with
Responsibilities: l Manage the implementation of capability initiatives and quality control of final deliverables. l Drive the needs assessments, capability program design, delivery, measurement and embedding with a strong focus on external engagement excellence. l Ensure
The Associate Director of Medical Affairs, Multiple Myeloma (MM) Medical Science Liaison (MSL) will be responsible for organizational operation and people management of the MM MSL group, reporting to the Director of Hematology, Medical Affairs Japan. A strong insight into the
Responsibilities: • Manage the implementation of automation technologies to streamline creating and updating mandatory materials. • Drive comprehensive assessments of available automation technologies tailored to pharmaceutical documentation. • Prioritize vendors with experience in similar automation projects
Responsibilities: l Manage the implementation of capability initiatives and quality control of final deliverables. l Drive the needs assessments, capability program design, delivery, measurement and embedding with a strong focus on external engagement excellence. l Ensure
POSITION SUMMARY •Responsible for leading the MSL group activities. •Support for HCPs through timely dissemination of emerging scientific and medical information from amultitude of sources. •Analyze and identify key MSL insights, and provide to the DA team
POSITION SUMMARY • Responsible to develop the Medical Affairs product strategy through the analysis of medical needs collected from all internal & external stakeholders of the therapeutic area • Responsible for leading MAF studies / publications in alignment with
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
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Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
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
This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 (
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Title: Clinical Affairs Specialist III, in vitro diagnostics (IVD) At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join
Work Schedule Other Environmental Conditions Office Job Description When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe.
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in
•Position Purpose •Develop and deliver strategies to give our company customer facing teams a competitive edge with personalized engagement as well as data-driven insights using advanced commercial processes, systems and tools •Key Responsibility Areas •Establish the
Position Purpose Develop and implement the business strategy for the HEM product portfolio, with both short-term and long-term business objectives. Oversee and lead all marketing and sales plans to achieve the business objectives within policies and
Position Purpose Maximize urothelial cancer business managing in-line prostate cancer product and developing bladder cancer portfolio(New products) Develop synergistic strategy of PC and BC to deliver holistic approach Deliver the agreed forecast budget and business plan
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