JOB DESCRIPTION: MAIN PURPOSE アボットメディカルジャパンが取り扱う循環器領域の医療機器（主にクラスⅣの高度管理医療機器）において、薬事担当者として高い専門性と自立性をもって薬事業務を主導し、製品の承認取得およびライフサイクル全体にわたる規制対応を推進します。 シニア～プリンシパルレベルの 個人貢献型プロフェッショナル として、複雑性の高い案件や関係部門・規制当局との調整をリードする役割を担います。 MAIN RESPONSIBILITIES - 当社製品における承認申請、変更申請、定期報告等の作成・提出の主担当 - 規制当局（PMDA等）との照会対応、折衝を通じた承認取得の推進 - 製品ライフサイクル全体（開発～上市後）における薬事対応のリード - 社内関係部署（研究開発、品質、製造、マーケティング等）との横断的な調整および助言 - 規制要件・ガイドラインの解釈を踏まえた薬事方針の検討・提案 - グローバル薬事チームとの連携、情報共有、英語での会議・文書対応 （プリンシパル相当の場合） - 組織内における薬事の専門的相談窓口 - 若手薬事メンバーへの助言・支援 QUALIFICATIONS 必須要件 - 理系学士卒以上（修士・博士歓迎） - 医療機器薬事の実務経験：5年以上 - クラスⅢ／Ⅳ 医療機器に関する薬事経験
Job Description Summary外科手術における可視化技術（超音波画像診断）の臨床価値向上と市場拡大に貢献するポジションです。医療現場への製品導入支援や営業チームとの協働を通じて、Surgical Visualization領域のビジネス成長を担っていただきます。 GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and
Job Description SummaryCoordinate and expedite the flow of materials (from suppliers and also within departments) according to production schedules. Plan and schedule material/production needs. Impacts quality of own work and the work of others on the
Job Description SummaryGE HealthCare Japanでは、医療機器の薬事業務を担当いただく Sr. Associate Specialist, Regulatory Affairs を募集しています。 本ポジションは、クラスⅡなどの特定モダリティ主に能動デバイス医療機器における薬事業務を担当し、直属の上司またはプロジェクトリーダーの指導のもと業務を遂行します。申請プロジェクトの進捗については、必要に応じて関係者へ報告を行います。 また、規制当局や業界団体と連携しながら業務を進めるとともに、業務遂行にあたりビジネス上の重要な要素および常に変化する規制要件を理解することが求められます。 GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock
Job Description SummaryCoordinate and arrange on-time shipments to customers in accordance with order requirements. Serve as the site focal contact with Global PSI, inter-plant teams, regional OTR, Distribution Centers, and Global S&OP to meet PSI and
Job Title: Work and Family Life Specialist (Remote) Summary Work and Family Life Specialists (WFLSs) provide one-on-one consultation, education, training, and information and referral services in support of the Work and Family Life (WFL) Program areas of the
Job Type Full-time Description POSITION OVERVIEW The Claims Resolution Specialist plays a critical role in the healthcare revenue cycle by ensuring the accurate and timely submission and resolution of insurance and patient claims. This position is responsible
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best.
Req ID: 133254 Remote Position: No Region: Asia Country: Japan State/Province: Miyagi City: Miyagi General Overview Functional Area: OPS - Operations Career Stream: CPM - Customer Program Management Role: Specialist SAP Short Name: SPE Job Title: Customer
Job Description Summary医療機器（特に画像診断装置）に関する価格設定業務を支援する役割を担います。 営業部門の企画支援、デジタルツールの導入・運用、オペレーションサポートを通じて、社 内の意思決定を円滑に進めるためのデータ管理・分析・文書作成などを行います。 本ポジションは、当社のインクルーシブ採用の一環として募集しています。 障害をお持ちの方からのご応募を歓迎しており、選考および就業にあたり合理的配慮を提供いたします。 GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sales Specialist, Oncology to join our Oncology Sales team, supporting our oncology business
Challenge Yourself and Impact the Future! Element Solutions Inc (NYSE:ESI) is a leading specialty chemicals company whose operating businesses formulate a broad range of solutions that enhance the performance of products people use every day. Developed
Challenge Yourself and Impact the Future! Element Solutions Inc (NYSE:ESI) is a leading specialty chemicals company whose operating businesses formulate a broad range of solutions that enhance the performance of products people use every day. Developed
Simplot Canada (II) Limited is a wholly owned subsidiary of the J.R. Simplot Company. The J.R. Simplot Company is a diverse, privately held organization, with roots firmly planted in agriculture and agriculture-related businesses. The J.R. Simplot
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.