Jobs list of Pharmaceutical
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NEWJob number: JN -122024-180697 Posted: 2024-12-02
【東京または大阪】製剤の「委受託・技術移転」経験が活かせる、新規ビジネスの立ち上げ業務
製剤の委受託案件経験者必見です!6.02 - 10.1 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- 同社は、幅広く医薬品を扱う会社です。
- Responsibilities
- 海外製造所への製剤製造委託において、製造技術の視点も交えてプロジェクトの立案から確立までを主導していただきます。
日本市場での安定供給に資する業務に自ら直接的に関わる事ができます。
処方の確立された製剤の海外製造委託先候補の調査、製造販売業者への製剤製造委託提案、製造販売業者及び海外製造業者との各種交渉。
具体的には:
海外製造業者（委託先候補）の製造設備、製造能力、本邦規制当局の要求事項へ応えられるかの評価。
製造技術移転時の製造販売業者及び海外製造業者との間に立ち、製造技術並びに品質管理方法、価格、納期等の交渉。
部署内における製剤についての技術・知識の共有及び指導。
Martin Tsvetkov
Pharma -
NEWJob number: JN -122024-180691 Posted: 2024-12-02
【本郷三丁目】学術（学術情報の収集・提供／学術セミナーの企画・推進など）
臨床の知識・経験のある方必見です!5 - 7 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- 同社は眼鏡・コンタクトレンズケア事業を展開しています。
- Responsibilities
- 医師、視能訓練士等とのコミュニケーションを通じた、学術情報の収集・提供、紐帯強化
学術セミナー・学会展示等の企画・推進
国内外の大学・眼科施設・企業等との学術研究・連携・勉強会等の推進
学術情報の社内共有・営業活動への技術サポート等
週1回程度の国内出張、2～3か月に1回程度の海外出張（主に東南アジア）があります。
Takahisa Hitotsumatsu
Medical Device -
NEWJob number: JN -112024-180118 Posted: 2024-12-02
海外現地法人責任者（ASEAN諸国の責任者）
マーケティング～M＆Aなど幅広い経営の仕事を紹介できます10 - 20 million yen Overseas Pharmaceutical Marketing
- Company overview
- Our client is a pharmaceutical company.
- Responsibilities
- 業務内容：
ASEAN諸国の子会社の責任者候補として入社いただくことを想定。
現法の責任者として事業経営全般をお任せします。
リーダーシップを発揮して事業計画の策定から推進を担い事業拡大に意欲的に取り組んでいただくことを期待
責任者 ：海外現地法人の事業経営全般
Momoka Yamashita
Pharma -
NEWJob number: JN -092024-176771 Posted: 2024-12-02
Senior CRA
全力で仕事に取り組む社員／自ら働き方を選べる0 - 0 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a global pharmaceutical company with offices across 81 countries.
- Responsibilities
- Main responsibilities:
For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
Anticipate and identify site issues that could affect timelines and develop alternative solutions.
Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise.
Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements.
Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
Responsible for coaching and mentoring CRAs and providing input into their development.
Responsible for mentoring CRAs for various aspects of work.
May be responsible for being the country point of contact for CROs for an assigned study.
May participate/lead in global/local task forces and initiatives. Responsible for activities as
assigned by manager.If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
If assigned; With guidance, may serve as key point of contact in country/district for assigned study.
Update Impact/Tesla with country-level information: Country-level planning timelines, LSR
assignments, etc.If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives.
Provides feedback on investigators/sites on an on-going basis based on the site performance.
Interacts and builds professional and collaborative relationships with peers and site monitors.
Elaine Montes
Pharma -
NEWJob number: JN -072024-143283 Posted: 2024-11-29
[Osaka & Tokyo] Clinical Research Associate (CRA) in Operation
Rewarding Career, Global Development9 - 14 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.
As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine. - Responsibilities
- MANAGE / MONITOR THE PROGRESS OF YOUR TRIAL ON-SITE OR OFF-SITE, AND CONDUCT, RECORD, AND REPORT YOUR TRIAL IN ACCORDANCE WITH CLINICAL TRIAL PROTOCOL, SOPS, ICH / J-GCP, AND OTHER APPLICABLE LAWS AND REGULATIONS. GUARANTEE THAT YOU ARE
RESPONSIBLE FOR CONTRACT NEGOTIATIONS AND CONCLUSIONS WITH MEDICAL INSTITUTIONS
WORK CLOSELY WITH OTHER CLINICAL TEAM MEMBERS TO TIMELY RESOLVE ANY CLINICAL TRIAL ISSUES THAT ARISE
INEXPERIENCED GIVE APPROPRIATE GUIDANCE TO MEMBERS AND CONTRIBUTE TO THEIR GROWTH
Patrick Chang
Pharma -
NEWJob number: JN -112024-179098 Posted: 2024-11-29
Overseas RA Associate Director
Pharmaceutical or food development experience welcomed8 - 14 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- 同社は、OTC医薬品や健康食品等の製造・販売を行う日本の製薬会社である。
- Responsibilities
- Regarding Company's Pharmaceutical products sold overseas, we are in compliance with Japanese andoverseas regulations regarding the products, manufacturing plants, and pharmaceutical ingredients. To understand the development and regulatory affairs of the project and to be able to carry out the development and regulatory affairs of the project. The following are examples of the duties of this position, but the specific tasks will be determined based on the individual's experience and aptitude.In order to obtain approval from overseas regulatory authorities for the pharmaceutical ingredients, formulations, and manufacturing sites used in products for overseas markets. Comply with overseas pharmaceutical regulations, collaborate with internal and external stakeholders, and develop and execute a pharmaceutical application strategy to obtain approval from the authorities (preparing various certificates, CTDs, and other application documents, and responding to inquiries).
Main responsibilities:
Planning and execution of development strategies and plans for new products for overseas markets
Drug regulatory research, evaluation of subcontractors and conclusion of contracts, project promotion
Acquisition of various certificates, preparation of application documents such as CTD, response to inquiries from regulatory authorities in each country, etc.
Maintenance of approval for products already approved overseas, planning and execution of change management plans
Promoting approval maintenance and change management in line with the latest regulations, and obtaining approval from authorities
Elaine Montes
Pharma -
NEWJob number: JN -112024-180645 Posted: 2024-11-29
医薬品開発における臨床薬理業務
医薬品の研究開発の経験が活かせます。5.59 - 8.91 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
- Responsibilities
- 開発プロジェクトの臨床薬理部門の主担当として、臨床薬理の観点での開発計画を立案する（臨床薬理試験の計画及びデザイン、用法用量提案や試験デザイン検討に用いるファーマコメトリクス解析の計画、血中薬物濃度及び抗薬物抗体の測定）。
各臨床試験における臨床薬理関連データの取得、解析及び結果の考察を行う。
臨床試験、当局相談、承認申請関連の臨床薬理パートの資料を作成する。
海外を含む規制当局対応や導出入活動の対応を行う。
Martin Tsvetkov
Pharma -
NEWJob number: JN -112024-180635 Posted: 2024-11-29
医薬品開発におけるCMCプロジェクトマネジメント
医薬品の原薬または製剤技術に関する専門的知識をお持ちの方必見です!6.36 - 12.6 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
- Responsibilities
- CMC開発部門におけるバイオ医薬品のプロジェクトチームのマネジメント（開発/上市プロジェクトのLCMを含むCMC開発戦略・計画策定とCMC関連部門の調整）
国内外の治験薬・商用生産体制の構築および治験薬・製品供給計画の策定と実行
CMC戦略、薬事規制等の情報収集及び発信
Martin Tsvetkov
Pharma -
NEWJob number: JN -112024-179086 Posted: 2024-11-28
Critical Care Business Manager (MR)
Global leader in specialty pharmaceuticals w/ rich history8 - 14 million yen Tokyo Pharmaceutical Sales / MR
- Company overview
- 欧州に本社を構えるスペシャリティファーマの日本法人です。
- Responsibilities
- Main responsibilities
Professionally managing assigned territory through the targeting of key customers (physicians, biomedical engineers, nurses and pharmacy).
Promoting products according to approved product labeling and marketing strategies.
Conduct financial analysis of accounts and carry out contract negotiations compliant with the procurement processes of the key account and/or Health networks
Developing strategic territory management plans to ensure revenue growth with company products.
Meeting assigned customer promotional reach and frequency goals.
After hours calls duties for the Customer Care after hours call roster, which is based on a rotational roster amongst the front-line team members.
Communicating effectively with specialty physicians.
Providing manger timely reports on work hours, sales call data, customer objectives, communications responses and expense reporting.
Working well without supervision.
Demonstrating aptitude for learning technical and scientific product-related information.
Demonstrate a high level of negotiation and influencing skills. Experienced in the contracting and tendering processes within the Japanese hospitals landscape.
Demonstrate a high level of competency in the analysis and interpretation of sales data and translating the insights and knowledge into executable action plans at the account/territory level.
Managing monthly invoicing activities by confirming product hourly usage and receiving hospital confirmation prior to invoicing.
Successfully managing relationship with partner companies to ensure smooth supply product to hospitals.
Completing all Post Market Surveillance tasks, such as contracting, CRF collection and reporting, in a timely manner
Operating within approved budget guidelines
Providing excellent field communication and direction i.e., emails, voicemails, conference calls, etc…
Co-ordinating activities with Field Teammates, Internal Teammates, Medical Affairs, Marketing, Customer Care, Finance, Operations and Technical Support.
Adhering to company policy, procedures and the comprehensive compliance program.
Elaine Montes
Pharma -
NEWJob number: JN -072024-137931 Posted: 2024-11-27
Non-Clinical Manager
1st Non-Clinical Member in Japan10 - 12 million yen Tokyo Pharmaceutical Pre-Clinical Trials
- Company overview
- We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
- Responsibilities
- Contribute to the development the strategy from nonclinical perspective.
Provide / lead the nonclinical-related parts of regulatory documents.
Interpret the outcomes from studies for clinical and plan/manage appropriate studies.
Martin Tsvetkov
Pharma -
NEWJob number: JN -112024-180406 Posted: 2024-11-27
【東京】臨床開発（立案・推進・管理業務）
アライアンスマネージメント経験者必見です!6 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- -
- Responsibilities
- 医薬品開発における臨床開発の立案・推進・管理業務※プロジェクトの管理・CROマネージメント・アライアンスマネージメントなどを担っていただく業務です。
Elaine Montes
Pharma -
NEWJob number: JN -112024-180348 Posted: 2024-11-26
ドラッグセイフティー担当者
PVにおける3年以上の経験をお持ちの方必見です。6 - 9 million yen Tokyo Pharmaceutical Pharmacovigilance
- Company overview
- Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies. - Responsibilities
- 報告スケジュール内で症例処理活動を実施し、グローバル症例管理および PMDA に症例を提出します。
CD&O と協力して、SUSAR および IND レポートを含む安全性情報を研究施設/研究者に広めます。
PMDAとの協議やサプライヤーとの調整を含む、臨床試験の症例処理プロセスを設定する
BIの戦略や国際規制に応じたシステム更新を含むPVデータベースの維持
NBI の治験薬および市販化合物の現地安全性プロファイルを GPSPV TA を含む関係者に確実に伝達する
GPSPV TA と緊密に連携して J-RMP を開発および更新し、割り当てられた TA 内で NBI 製品の現地安全性プロファイルの評価を確実に行う
地域レベルで割り当てられたTA製品に対して必要に応じてリスク最小化対策を実施および監視し、安全問題を地域の管理者、地域のPSPV責任者、およびGPSPVと調整します。
現地の定期的な安全性報告書の作成を確実にし、必要に応じて国際製品について GPSPV のグローバル製品責任者とレビューサイクルを調整します。
現地の検査準備を確立およびサポートし、必要に応じて PV 監査および PV/GPSP 検査に参加し、必要に応じて CAPA プロセスに貢献します
規制、グローバル/ローカルのPV SOP に関するハイレベルなトレーニングを実施する
SOP と WI を準備し、PSPV 内の他のチーム、または安全性の問題について臨床チームやマーケティング チームと協力する
Martin Tsvetkov
Pharma -
Job number: JN -072024-36722 Posted: 2024-11-25
マーケティング
循環器領域、下肢領域のプロダクトマネージャー経験もしくはそれに近い経験をお持ちの方必見です。5 - 8 million yen Tokyo Pharmaceutical Marketing
- Company overview
- Our client is a medical device manufacturer.
- Responsibilities
- 市場調査フォームの作成
市場調査結果の分析、それに基づく営業拠点とのマーケティング戦略の策定と実行支援
マーケティング戦略実行時の効果測定や修正プランの策定
疾患や治療などの基礎知識習得のための教育資料作成
新製品上市や既存製品の拡販のためのトレーニングツールの作成やトレーニングの実施
Risa Harada
Medical Device -
Job number: JN -082024-172297 Posted: 2024-11-22
トランスレーショナル研究
グローバルな環境で自立した病理専門家としての活躍7 - 11 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 業務内容：
病剤の研究・開発において病理解析担当として、主に標的たんぱくに対する免疫組織化学（IHC）評価系の構築および分子 病理化学的評価の実施 構築した IHC 評価系の試験受託先への移管、問題解決対応 病理解析担当として、グローバルプロジェクトチーム、国内外共同研究先、治験医師等への研究成果の発信およびサイエンスベ ース議論への参画を通して、病剤開発の意思決定への貢献 研究成果の社外への発信（学会発表、論文投稿等） 病理解析に関する多重 IHC 染色解析を含む新しいプラットフォーム構築やインフラ整備
Momoka Yamashita
Pharma -
Job number: JN -102024-178630 Posted: 2024-11-22
海外薬事
グローバル薬事リーダーとして米国への転勤が可能です。7 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 業務内容：
アジア地域における医薬品の開発段階から販売終了までの薬事業務を担当する。
臨床、非臨床、品質等、幅広い分野で構成されるグローバルチームおよび現地の薬事担当者と連携して、薬事戦略の立案、規制当局との協議・折衝、申請資料作成、ライセンス維持管理などを遂行する。
Momoka Yamashita
Pharma -
Job number: JN -072024-168087 Posted: 2024-11-22
ヘルスケアアフェアーズプランニングマネージャー
製薬業界での最低5年の経験をお持ちの方必見です。9.8 - 14 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR
- Company overview
- Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies. - Responsibilities
- 各疾患領域（TA/Therapeutic Area)、Medical、CAなどの社内ビジネス機能との連絡役として行動し、幅広いMAHA(Market Access, External Affairs, HEOR, Pricing, Distribution Management, Patient Engagement, Regional Access)イニシアチブを調整および統合します。
全社的およびTA／資産／対象疾患固有の視点を理解した上で、ヘルスケア・アフェアーズ・プランを他の部門横断的なプラン（IBP、ICP、LRなど）と有機的に組み合わせて同期させ、MAHA活動が会社と整合するようにします。
戦略とTA・資産戦略は、同時に外部環境とその変化を正しく理解し、早期に自社戦略、TA・資産戦略、MAHA戦略など、さまざまなレベルの戦略に反映させます。
Martin Tsvetkov
Pharma -
Job number: JN -072024-38976 Posted: 2024-11-22
Director: RWE Partnerships & Innovation
Director position at global mega pharma16 - 30 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR
- Company overview
- This company is the world\'s leading pharmaceutical company.
- Responsibilities
- The RWE Partnerships and Platforms organization functions to:Enhance company's ability to determine unmet medical needs;
Support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE);
Inform clinical practice on appropriate prescription and use of company products;
In collaboration with Access & Value, strengthen the value evidence package for payers and access/policy decision-makers;
Support measurement of short- and long-term impact of company products to both patients and populations;
Support competitive differentiation.
This position will serve as the Real World Data point of contact for either one category or one geographic region.Execute on prioritized tactical plans with actionable projects, identify external partners to deliver strategic RWE capabilities / data, and oversight of high quality methods and designs to inform study / project designs for R&D franchise / asset teams, CMAO, Health Economics and Outcomes Research, Commercial and other functions’ needs
Provide daily mentorship, motivation, and guidance to more junior RWE colleagues, & direct them to co-develop emerging, core a strategic partnerships with commercial and academic data suppliers
Supports landscape assessments, new data / tool / partner due diligence assessments based on understanding evolving healthcare, technology and other industries with Customers, RWE Digital platform team, Digital RWD Enterprise Enabling Platform, RWE Biostatistics and other relevant partners
Documents all requests and track progress toward project completion, other metrics and business goals
Develops training materials for ensuring colleagues understanding and competency in various aspects of the RWE process
Communicates critical knowledge on business processes to relevant stakeholders
Yui Osone
Pharma -
Job number: JN -112024-180099 Posted: 2024-11-22
提案書作成業務
バイオテクノロジーを用いた医薬品開発、製造に関する基礎的な理解がある方必見です。6 - 11 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a leading comprehensive glass manufacturer in Japan. Our business extends beyond glass to include electronics, chemicals, and ceramics, resulting in a well-balanced revenue composition that makes us resilient even in economic downturns. We develop and manufacture innovative materials and products across a wide range of fields, leveraging our high technological expertise and research and development achievements. We supply products to various industries such as construction, automotive, electronics, and medical equipment. Furthermore, we are committed to environmental conservation and the development of sustainable technologies, earning us recognition as a socially responsible company.
- Responsibilities
- 世界中のお客様から受領した開発・製造委託の提案書作成依頼（RFP:Request for Proposal)の内容を分析する
主に千葉工場の技術チームなどと綿密に連携し、お客様に提出する提案書の作成を行う
グローバルの価格決定会議に参加し、提案内容の発表を行い、承認を得る
主に千葉工場や、ウェブなどで、お客様との会議に参加し、提案書の説明、協議を行い、提案書の改訂作業を行う
より競争力のある提案書を作成するため、主に千葉工場の技術チームやグローバルのチームと一緒に、改善活動を行う
Martin Tsvetkov
Pharma -
Job number: JN -112024-179804 Posted: 2024-11-21
臨床開発計画の立案を担うクリニカルサイエンスリーダー
製薬メーカー等での臨床開発業務経験が活かせます。11.1 - 12.6 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
- Responsibilities
- Immunology領域における臨床開発計画の立案（後期開発品における市場価値最大化の検討含む）
臨床試験のプロトコルの策定
当局相談資料や申請資料などRegulatory Agenciesとの対応と方針の決定
国内外Key Opinion LeaderおよびRegulatory Agenciesとの折衝
導入候補品の臨床科学的評価
臨床試験の外部への発表に関する業務
Martin Tsvetkov
Pharma -
Job number: JN -112024-179890 Posted: 2024-11-20
メディカルアドバイザー
臨床研究の立案・計画、実行の経験及びプロジェクトマネージメント能力をお持ちの方必見です。6 - 11.5 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies. - Responsibilities
- グローバルの開発戦略、メディカルプランニングを日本のrepresentativeとしてグローバルと密に協業しながら共に作成、実行
日本のニーズに合わせたマーケット部門との協働でのGlobal Integrated Asset Plan（IAP）に沿ったIntegrated Customer Plan（ICP）の作成
グローバルの開発戦略や顧客からのインサイト、アンメットニーズに沿ったメディカル戦略・戦術の作成と実行を内外のステークホルダーとともに計画し実行
ドイツ本社メンバーとの戦略および活動レビュー会議への出席と貢献
ベーリンガーインゲルハイムのプロダクトを支えるための、日本の外部専門家との強いネットワークの構築
アドバイザリーボードの企画立案及び実施
臨床研究や医師主導臨床試験、RWD研究を通して外部専門家と協働し、価値あるデータを創出してデータギャップやアンメットニーズを埋める
各プロジェクトの質を担保しながら，タイムライン及び予算を考慮し進行する適切なマネジメント
メディカルインフォメーションの準備及び提供のサポート
PMSに対するメディカルアドバイス、サポート
法規制や業界ルール（プロモーションコード、公正競争規約、個人情報、データ収集／保管など）、関連SOP を理解し、遵守する
Martin Tsvetkov
Pharma