Jobs list of Pharmaceutical
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Job number: JN -122024-182146 Posted: 2025-01-08
【東京】海外ビジネス担当＜ME機器＞《離職率2%程＊在宅勤務あり》◆日本最大級の医療メーカー◆
グローバルにおける輸液システムの成長にチャレンジできます5.5 - 8.5 million yen Tokyo Pharmaceutical Marketing
- Company overview
- We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
- Responsibilities
- ■職務内容：【変更の範囲：会社の定める業務】当領域の海外ビジネスは黎明期であり、地域別のマーケティング機能を日本本社から積極的に推進・強化いただきます
新興国では、現地生産に有利なビジネス環境（税制、入札要件）が構築されており、より柔軟なポートフォリオ構築が重要です。この状況を積極的に活用し、ビジネスの拡大を推進いただきます
ビジネス拡大のため、今まで未着手だった領域への展開を目指していただきます
【担う役割】ME機器（輸液・シリンジポンプ）の取り巻く海外市場動向や市場機会、規格規制を考慮した事業計画/マーケティング戦略の策定
海外の地域毎における製品戦略立案及び新たな価値創造の製品への反映
海外企業と連携し、現地での製品立上げ及び市場導入を行う
海外販売拠点とコミュニケーションを取り、マーケティングの推進・人材育成
【仕事の魅力】カンパニーの売上・収益を牽引するチームであり、その中でも成長戦略の中核となる海外展開を牽引するポジションです。
海外担当のメンバーはいずれも若く、柔軟な発想で、新しい成長機会に向けて皆が明るくチャレンジしている環境です。
ME機器（輸液・シリンジポンプ）以外に、輸液システムを構成する輸液セットやデジタルソリューションのアソシエイトと密に連携し、輸液システムとしての海外戦略立案・ソリューションの発案・実行が可能です。
現在、アジア・南米・欧州・中国にて海外展開を実施、海外アソシエイトと連携し、グローバルにおける輸液システムの成長にチャレンジできます。
■働き方について：制度として在宅勤務・フレックスが利用可能となっております。現メンバーの実際の取得頻度は週2～3回程度です。
国内、海外出張の頻度は多く、海外：月1～2回程度、国内：月4回程度となります。
Martin Tsvetkov
Pharma -
Job number: JN -072024-39764 Posted: 2025-01-08
開発薬事担当
グローバルトップシェア／福利厚生や休暇制度も充実6 - 11 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
- Responsibilities
- ■職務内容：
グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築 規制当局（厚生労働省、独立行政法人医薬品医療機器 総合機構など）との窓口業務 承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する 承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション 新薬承認申請に関する薬事情報の収集・分析、関係者への提供／共有 当局対応（30日調査、対面助言、申請準備、審査対応）の際の、米国本社も含めた社内調整（スケジュール管理）
■カルチャー／環境について：
パイプラインに恵まれており、また外資の中では比較的穏やかな社風なので、じっくりキャリアを積むのには良い環境となっております。副業も認められており、ジョブポスティング制度によるキャリア形成も充実しております。フラットでスピーディーな組織体制となるべくアジャイル組織を導入するなど、働き方への変化へ非常に前向きな企業でございます。
Patrick Chang
Pharma -
Job number: JN -072024-39673 Posted: 2025-01-08
【茨城】原薬品質試験法開発研究（リーダー候補）
大手Gで安定就業・残業ほぼなし・有給休暇取得率77%8.1 - 11 million yen Ibaraki Pharmaceutical Research & Development
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- ■職務内容：
創薬研究部門において、モダリティ問わずゼロベースから医薬品原薬の分析・試験法開発にチャレンジ頂ける研究者を求めております。
＜具体的に＞
創薬研究部門における原薬試験法開発研究チームリーディング
創薬研究部門における原薬試験法開発研究実務遂行
CMC部門及び各種原薬・中間体製造委託先への試験法関連技術の情報移管
分析研究を効率化するための各種情報収集、技術獲得及び機器導入
■キャリアパス：
弊社では研究業務の自由度が高く、専門性を高めたい、他の領域にも携わりたいなど、ご本人のキャリアプランを尊重する環境です。
■研究所の魅力：
当研究所では創薬化学、製法開発、試験法開発、プレフォーミュレーションを一貫して実施できる環境となっております。部門も縦割りではなく横串で連携をしており、他部門とのコミュニケーションも円滑に行っております。
Patrick Chang
Pharma -
Job number: JN -012025-182487 Posted: 2025-01-08
メディカルインフォメーション
薬剤師資格もしくは理系修士以上をお持ちの方必見です。5 - 6.5 million yen Osaka Pharmaceutical Clinical Development
- Company overview
- Our client is providing a variety of services to pharmaceutical and medical device companies and other healthcare companies.
- Responsibilities
- 学術情報の収集、評価、集積
社内に向けた戦略や資材作成、学術情報提供
外部向け使用スライドの学術的検証
Patrick Chang
Pharma -
Job number: JN -012025-182471 Posted: 2025-01-08
リアルワールドCPM
SSV～COVの戦略立案及び進捗管理の経験をお持ちの方必見です。7.5 - 14 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
- Responsibilities
- 臨床研究・医師主導治験のClinical Lead またはProject Leadとして次のような業務をお任せします。得意業務やキャリアパスに応じて役割を決定します。
【Clinical Lead】倫理指針または臨床研究法下で実施される臨床研究におけるClinical Operationのマネジメント
CRAのリーダーとして、SSV・SIV・症例登録促進・SDV・データクリーニング・COV業務の、1. 戦略策定、2. CRAへの指示、3. 進捗管理、4, リスクマネジメントを担う
【Project Lead】倫理指針または臨床研究法下で実施される臨床研究のプロジェクトマネジメント
バーチャル組織のリーダーとして、試験立案～Publicationまでの、1.タイムライン、2. 予算、4. 人員、4. リスク、を管理する
RFPに対する見積書及び提案書を作成する
Patrick Chang
Pharma -
Job number: JN -122024-182077 Posted: 2024-12-26
【京都・長岡京】保健士（安全衛生 健康管理スタッフ）◆在宅勤務・フレックスタイム制度有／年休127日
働きやすさ◎＜年休127日・土日祝休・フレックス有5 - 10 million yen Kyoto Pharmaceutical Nurse
- Company overview
- This company is a semiconductor manufacturer.
- Responsibilities
- ■具体的な仕事内容：健康管理室としての産業保健業務を担当いただきます。健康診断、面接指導等の実施及びその結果に基づく労働者の健康を保持するための措置、作業環境の維持や作業管理等の労働者の健康管理に関する指導業務
健康相談やその他労働者の健康の保持増進を図るための措置に関する業務
労働衛生教育や健康教育、健康障害の原因の調査及び再発防止のための措置に関連する内容の業務
健康管理上必要な従業員の情報管理を人事部門と連携し、各種健康診断対象者の選定及び組織管理者展開への支援業務
Martin Tsvetkov
Pharma -
Job number: JN -122024-182154 Posted: 2024-12-26
プロジェクトマネジメント（原薬開発）
製薬企業またはCDMOにおけるCMC領域の実務経験を５年以上お持ちの方必見です。7 - 9 million yen Saitama Pharmaceutical Regulatory Affairs
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- 原薬開発のプロジェクトマネジメント及び治験原薬、中間体、原料の調達関連業務をお任せします。合成及び分析研究員から構成された原薬開発チームのチームビルディング
グローバル又はローカルプロジェクトの原薬開発戦略及び計画の策定、推進
プロジェクトのスケジュール及び予算管理
外部委託先等を活用した治験原薬・中間体・原料の調達関連業務
Martin Tsvetkov
Pharma -
Job number: JN -122024-181826 Posted: 2024-12-20
医療機器プロジェクトエンジニア（PS部門）
医療機器、計測器分野の製品開発又は設計経験が活かせます。6.7 - 10 million yen Kanagawa Pharmaceutical Pharmacovigilance
- Company overview
- We are the Japanese subsidiary of the world\'s largest private inspection organization. We provide services through our global network in the fields of inspection and certification. We offer inspection and certification services in a wide range of fields. Our services include ISO certification, medical device certification, food safety management, certification testing of electronic products, and inspection of chemical products. We also offer a variety of seminars and training programs to help ensure safety and quality.
- Responsibilities
- プロジェクトエンジニア業務
お客様との技術的なコミュニケーション（メール、打合せなど）
試験計画の立案（評価対象から規格の該当項目を抽出し試験、測定方法へ落とし込み）
社内ラボ又は顧客施設で試験（自身で計測、試験または試験エンジニアと協力して実施）
技術的要求文書（IFU、RMF、UEF、ソフトウェアなど）の評価
試験報告書（主に英文）の作成
社内並びにグローバル/リージョナル会議、関係団体委員会活動への参加
認定範囲の維持と拡大業務
定期内部及び外部監査の準備と対応
認定範囲の拡大（必要な設備の選定、トレーナーとなりメンバーを教育、投資計画立案）
営業サポート業務
顧客向けの規格トレーニング
展示会での技術的サポート
Martin Tsvetkov
Pharma -
Job number: JN -122024-181704 Posted: 2024-12-18
CMCポートフォリオマネジメント
開発品を含む製品のライフサイクルを通じたCMC戦略経験をお持ちの方必見です。6 - 11 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
- IT技術を駆使したCMCポートフォリオマネジメントを構築し運用評価すること
CMCマネジメント業務における他の機能との役割分担の調整と業務フローの確定を推進すること
グローバル会議における英語での企画提案・答弁
Martin Tsvetkov
Pharma -
Job number: JN -122024-181680 Posted: 2024-12-18
【東京駅】細胞培養関連・再生医療関連製品のマーケティング※世界No.1シェア多数◎／福利厚生◎
在宅勤務可(12日/月 上限)、フレックス勤務可6 - 8.3 million yen Tokyo Pharmaceutical Sales / MR
- Company overview
- We are engaged in the development, manufacturing, and sale of chemical products, offering innovative solutions across a wide range of industries. Our products include functional polymers, synthetic resins, and chemicals, utilized in fields such as automotive, electronics, healthcare, and construction. We prioritize sustainable products and environmental considerations, actively pursuing innovative technologies and research and development. Moreover, we provide customized solutions tailored to our customers\' needs, establishing ourselves as a partner in the industry.
- Responsibilities
- ◆職務内容：再生医療およびバイオ医薬製造において用いられる、細胞培養担体SCAPOVARのマーケティングおよび営業活動をご担当いただきます。この製品は2024年3月に国内にて販売を開始し、2025年に海外でも販売開始を予定しています。新規顧客の開拓：市場調査とターゲット分析のもと、潜在的な顧客を発掘し、当製品の特性と利点を効果的に伝え、評価・購入に結び付ける業務
製品の開発・改良：市場のニーズや顧客評価のフィードバックを捉え、開発チームと連携し、製品の改良や新製品の開発を推進
マーケティング戦略の策定と実行：市場動向を分析し、効果的なマーケティング戦略を立案。展示会や紹介資料を通じてSCAPOVARのブランド価値向上、市場定着化の実行顧客訪問に加えて、展示会等のための出張（海外を含む）が月１回程度あります。
◆働き方特徴・福利厚生在宅勤務可(12日/月 上限)、フレックス勤務可、離職率2%以下、有給取得率9割以上と、長期就業が叶う環境です。
男性の育児参加を促進するため、男性の育児休職取得を推進しています。2024年度には男性の育児休業取得に関する数値目標を新たに設定し、さらなる取得を目指します。
DX人材やグローバル人材育成制度も充実しておりWLBも整えながらスキルアップが実現できます。
Martin Tsvetkov
Pharma -
Job number: JN -092024-176771 Posted: 2024-12-18
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
Medical Device -
Job number: JN -122024-181520 Posted: 2024-12-17
【東京】希少疾病用医薬品の開発薬事部員（プロジェクトリーダー候補）
新薬の承認申請経験者必見です!9 - 12 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- We are a pharmaceutical company specializing in the development and distribution of treatment drugs for rare diseases. Our goal is to bring smiles and happiness to patients and their families affected by rare diseases. We address challenges such as providing new treatment drugs, ensuring stable supply, improving diagnosis rates, and raising awareness of diseases. Additionally, we aim to expand sales through the handling of long-term listed products and the manufacturing and distribution of pharmaceuticals, ensuring the continued provision of new drugs. Our business includes the maintenance management of manufacturing and sales approvals, pharmaceutical manufacturing and sales operations, and sales management operations.
- Responsibilities
- 承認申請プロジェクトの運営・管理
申請資料（CTD M2.5、2.7、M5等）の作成・レビュー
企業主導治験の企画立案
医師主導治験・臨床研究に係る業務の社内外のコーディネート
パートナー企業（主に欧米）とのコミュニケーション
Martin Tsvetkov
Pharma -
Job number: JN -122024-181527 Posted: 2024-12-17
開発薬事部員
製薬会社において新薬の承認申請プロジェクトでの国内での申請経験がある方必見です。9 - 12 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- We are a pharmaceutical company specializing in the development and distribution of treatment drugs for rare diseases. Our goal is to bring smiles and happiness to patients and their families affected by rare diseases. We address challenges such as providing new treatment drugs, ensuring stable supply, improving diagnosis rates, and raising awareness of diseases. Additionally, we aim to expand sales through the handling of long-term listed products and the manufacturing and distribution of pharmaceuticals, ensuring the continued provision of new drugs. Our business includes the maintenance management of manufacturing and sales approvals, pharmaceutical manufacturing and sales operations, and sales management operations.
- Responsibilities
- 承認申請プロジェクトにおける戦略の立案
承認申請プロジェクトの運営・管理
申請資料（M1及びM2.2）の作成、M1及びM2のレビュー及び申請資料全体のとりまとめ
承認申請準備段階から承認取得までの社内外の調整、及び当局対応
パートナー企業（主に欧米）とのコミュニケーション
Martin Tsvetkov
Pharma -
Job number: JN -072024-3564 Posted: 2024-12-17
Marketing Director
Director10 - 18 million yen Tokyo Pharmaceutical Marketing
- Company overview
- This is one of the world’s leading pharmaceutical companies, providing products to customers in approximately 150 countries and territories.
- Responsibilities
- Develop multi-channel go-to-market strategic and tactical plans for therapy areas of focus
Lead the digital transformation to a hybrid MR model where multiple remote channels are fully integrated into MR’s promotional activities.
Collaborate with related stakeholders to optimize multi-channels and CLM activities
Increase efficiency of the e-MR team so that they can effectively disseminate message to relevant stakeholders through inbound & out bound calls.
Continuously evaluate emerging technologies, providing thought leadership and recommendations for adoption where appropriate.
Develop, implement and track digital marketing activities that are tightly linked to our commercial strategies
Closely collaborate with product teams to maximize utilization of digital channels
Measure and report performance on key activities and assess against goals (ROI and KPIs)
Build a strong digital marketing team through regular coaching and supervising of individual team members.
Develop the digital group budget to realize the strategy plan and ensure all the promotional/GA spending are in alignment with the annual budget plans.
Collaborating with Business partner M3, BT and StratCo to leverage new technology includes AI, RPA, OCR Remote for business efficiencies and negotiate with vendors to obtain cost effective deals
Ensure contracts with vendors and promotional materials related to digital activities are aligned with corporate / industry compliance and regulations
Martin Tsvetkov
Pharma -
Job number: JN -072024-8256 Posted: 2024-12-12
Head of Electronics Business Development Asia
M&A10 - 20 million yen Tokyo Pharmaceutical Sales / MR
- Company overview
- We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.
- Responsibilities
- You will have the key role to drive the identification and execution of growth opportunities in Asia: You will investigate the financial performance as well as the product portfolio and capabilities to assess the attractiveness and fit with our strategy.
You will work closely in a cross functional team with the Business Fields, the Heads of Business Development, Strategy and Portfolio within the Electronics Strategy and Transformation unit as well as supporting functions to select the most attractive opportunities.
Based on your strong interpersonal and negotiation skills and your existing network you will build strong relationships to the management of target companies and drive the execution with Group M&A.
Martin Tsvetkov
Pharma -
Job number: JN -122024-181262 Posted: 2024-12-11
品質保証
プロジェクトマネジメントの経験がある方必見です。5 - 8 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are the Japanese subsidiary of a healthcare product manufacturing and distribution company founded in the United States. Recognized as a workplace-friendly company in the healthcare industry, we offer a wide range of product lines. We supply various products necessary for surgeries and examinations to hospitals, care facilities, and other healthcare settings. The disposable nature of our products contributes to infection prevention and operational efficiency. With a focus on disposable surgical products, we provide a diverse range of offerings to meet the needs of our customers.
- Responsibilities
- 国内外で製造される医療機器等の有効性、品質および安全性の確保新製品・変更品導入に関わる品質関連タスクの実施・進行(変更管理案件の場合)
ディスコン手続き(品目・製造所・品番)
試験サンプル手配、各種バリデーションレビュー、包装アグリメント更新、滅菌テスト手配、滅菌アグリメント更新、カタログ・案内文レビュー、QAD薬事データメンテナンス
上記のための海外ベンダーとのコミュニケーション
既存品における不適合や苦情発生対応、不具合による被害拡大防止・品質改善
薬機法・ISO13485で求められる文書等を管理し、業態等維持
その他:問合せ、請求書処理、監査の実施、その他プロジェクト
Risa Harada
Medical Device -
Job number: JN -122024-180926 Posted: 2024-12-04
【静岡】プロテインケミスト（総合研究所）
創薬研究業務経験者必見です!5.1 - 8 million yen Shizuoka Pharmaceutical Research & Development
- Company overview
- Our client is selling, importing and exporting pharmaceuticals and other products.
- Responsibilities
- 総合研究所（御殿場市）における新規核酸医薬の創薬研究
核酸医薬プロジェクトにおける各種抗体・タンパク質の発現・精製・分析
Martin Tsvetkov
Pharma -
Job number: JN -072024-137931 Posted: 2024-12-03
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 -
Job 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 -
Job 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