私たちIQVIAは、ヒューマンデータサイエンスの先駆的な企業として、医療・ヘルスケアの前進に取り組む皆様をIQVIAならではの革新的なソリューションによってご支援することで、「誰もが、より健康に自分らしく生きられる社会」の実現を目指しています。世界最大規模を誇る医療・ヘルスケア関連データを基盤に、人・データ・サイエンスを融合させた見地から、未だ満たされない治療ニーズに応える、新たな医薬品や医療機器の開発と市販化、厳格化する規制やコンプライアンスへの対応、持続可能な医療システム推進の支援など、患者さんをはじめとするすべての人々のために、より良い未来へと医療・ヘルスケアを前進させていく力となることが、私たちの使命です。
世界100以上の国と地域で約9万人が活動するIQVIAの日本法人として、IQVIAジャパンでは約6,000人が一丸となり、この使命に向かって日々、力を尽くしています。
【部署・チーム名】
グローバルで先行していた「RADDS」(Regulatory Affairs & Drug Development Solutions)と呼ばれる新組織を日本でも始動。顧客のニーズに応じて薬事対応、開発戦略立案、臨床開発などのサービスを一体的に提供する体制を構築しました。グローバルとも連携して海外の新興バイオファーマ(EBP)を日本に呼び込むとともに、日本のバイオベンチャーの海外開発・申請をサポートします。
RADDS Japan was established to support EBP initiative for business growth in RD&S.
This position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement projects.
【業務内容】・Manage staff in accordance with organization's policies and applicable regulations; Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; Approve actions on human resources matters, including salary administration.
・Effectively manages the team's resources and delegates tasks commensurate with skill level; Evaluates workload, quality and metrics through regular review and reporting of findings;
Effectively collaborate with operational colleagues to manage project- and team-related challenges;
Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate.
・Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites;
Undertakes risk analysis and manages the outcome as appropriate;
・May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations;
・May provide strategic regulatory and/or technical consultancy on a variety of projects;
Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA;
May take leadership role in bid defense strategy and planning;
May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience;
メーカーやCROでの薬事経験者
ラインマネジメントの経験
・At least 8 years regulatory experience including 6 years management experience.
・Requires broad management knowledge to lead teams, and well as the ability to influences others outside of own job area regarding policies, procedures, and goals.
・Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
Line management experience required, with demonstrated success in development, engagement and performance of senior staff.
・Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers and staff
・Possesses an acute awareness of issues outwith the business function. Exudes confidence and authority within remit, and delivers a positive example to teams
・Communicates an inspiring vision of the Regulatory Strategic Plan and helps others understand and value their role in it.
・Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations
【部署・ポジションの醍醐味、楽しさ、やりがい】
・有用な医薬品の早期の開発、承認に貢献できる
・再生医療を含む、最先端の医療へ関与できる
・Projectをリードし、クライアントとのコミュニケーションを含め、自己完結で業務遂行できる
・様々な領域(治療領域、生物的製剤、再生医療等)での経験が積める
【特別な研修・サポート制度等】
・英語研修
・GCPなど各種社内外研修
・医薬品開発に関する部内外研修
・学会への参加
【雇用形態・勤務時間・福利厚生・休日休暇】
雇用形態:
正社員/契約社員など
勤務時間:9:00-17:30
フレックス勤務:
あり
在宅勤務制度:
あり 福利厚生:法定内(社会保険制度)・法定外(IQVIA独自制度)の両面から充実した福利厚生制度あり
受動喫煙対策:
あり
休日休暇:
年次有給休暇、夏季休暇、病気休暇、特別休暇、女性特別休暇、育児介護休暇、看護休暇
- など
試用期間:
あり(通常6か月)
【給与・待遇】
給与:
当社規定により優遇します
昇給:
あり
賞与:
あり
時間外手当:
あり
【選考プロセス】
書類選考→部門とのカジュアル面談→応募後、部門面接(3回あり)
【応募方法】
日本語の履歴書、職務経歴書、英語職務経歴書の3点をご準備ください。
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more atShow more Show less
-
Tokyo EMDGroupメルクと一緒に、あなたの力を発揮しよう · 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう · ...
-
Minato BD Nogales NorteBDは、ヘルスケア分野における多様なニーズに応える医療技術、デバイス、実験機器を開発する世界をリードする医療技術企業です。感染症の撲滅と治癒を目指す戦いにおいて最先端の研究を提供し国内外の人々に画期的な医療・バイオテクノロジーサービスへのアクセスを向上させるという私たちの使命で、私たちが求めています。 · ...
-
Minato BD Nogales Norte当社のライフサイエンス※製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · ...
-
Minato-ku BD Full time￥1,584,000 - ￥2,442,000 per year薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...
-
Chiyoda Real当社は革新的な医療技術を通じて医療現場の課題解決に貢献するグローバルメドテック企業です。 · 本ポジションでは医療機器のISO13485に基づく品質マネジメントシステム(QMS)の運用および改善を担当いただきます。QMS文書を作成・改訂し続続的なプロセス改善を行うことができます。また手順書を作り規制対応を行い、および輸送管理安全管理(Vigilance)まで幅広い領域で仕事をすることができます。 · ...
-
Tokyo BD ￥25,000,000 - ￥35,000,000 per year· BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...
-
Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full timeLife Science Regulatory Management、レギュラリースペシャリストとして業務を行う。東京勤務、週2日在宅ワーク可。 · ...
-
Tokyo BD ￥100,000 - ￥200,000 per year+ · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...
-
Minato IQVIAThis position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement proj ...
-
Shibuya Teva Pharmaceuticals Full timeThe Associate Director of Innovative Medicines Regulatory Affairs in Japan will lead the document preparation process to ensure high quality and timely submission as per the agreed workplan. · Accountable for the development and implementation of regulatory strategies in Japan. · ...
-
Ebisu, Tokyo Teva PharmaceuticalsWorking here means working with the world's leading manufacturer of generic medicines · ...
-
Tokyo Parexel Full time$100,000 - $200,000 per yearWhen our values align there's no limit to what we can achieve. · At Parexel we all share the same goal - to improve the world's health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something speci ...
-
Japan - Tokyo AmgenJob summaryFacilitate patient access to Amgen products in Japan through executing on our filing plans; providing strategic regulatory guidance on Japan regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating Am ...
-
Tokyo, Japan ZOLL MedicalThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...
-
Regulatory Affairs
3週間前
Tokyo ZOLL Medical CorporationThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...
-
Tokyo Gilead SciencesWe are looking for an Associate Director, Regulatory Affairs CMC to join our team. As a people leader now or in the future, you will play a critical role in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill th ...
-
東京都 千代田区, Johnson & JohnsonEthicon Wound Closure & Healing and Biosurgery is seeking a dynamic and experienced Senior Manager or Associate Director to join our Regulatory Affairs team in Japan. · ...
-
Chiyoda Johnson & Johnson MedTechEthicon Wound Closure & Healing and Biosurgery is seeking a dynamic and experienced Senior Manager or Associate Director to join our Regulatory Affairs team in Japan. · ...
-
Tokyo パーソルキャリア株式会社 BRS人材と組織の力を高め、ブランドを支えていただきます。全ての従業員が安心して働き、成長し、ブランドに誇りを持てる環境の創出をお任せします。 · シンガポール本社の方針を理解し、日本での戦略立案と実行 · 勤怠管理と給与支払いの管理・責任 · Aprovechamiento estratégico: Análisis de datos para tomar decisiones informadas sobre recursos humanos. · ...
-
Japan ColgateThe Regulatory Affairs Manager supports the Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. · ...
-
Minato RegeneronWe are now looking for in-country regulatory professionals to join our growing global regulatory team.This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for biological products and regenerative medicines in Japan. · ...
