Jobs list of Pharmaceutical
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Job number: JN -072024-129452 Posted: 2025-06-01
Site Activation Specialist/In-House CRA
グローバル臨床試験における契約交渉および費用交渉のご経験が活かせます！5 - 7 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
- 【1】Site Activation業務
Investigator recruitmentおよびfeasibility
治験施設との臨床試験契約の交渉と継続的な管理。
臨床試験実施における治験施設のタイムリーな立ち上げをサポートするための契約実行スケジュールの管理
部門のガイドラインに基づき、社内外の関係者に法律や予算の問題を伝え、説明し、国特有の法律や規制が守られていることを確認
クライアントの要求した契約変更をレビューし、評価し、部門のガイドラインに基づいて、適切に逸脱を報告
契約書の完全性と正確性を評価し、部門のガイドラインに準拠しているかどうかを確認し、契約書を修正し、契約書変更のファイリング
【2】In-House CRA業務
被験者のscreening/enrollmentサポート
CRFのチェックおよび回収サポート
Clinical supply/service vendorsおよび社内関係チームとの連携
CTMS等の使用による費用請求・支払の対応
必須文書の収集・レビュー・管理およびclose-out
Patrick Chang
Industrial & Life Science -
Job number: JN -052025-188993 Posted: 2025-05-29
MSL（フィールドメディカルスタッフ)
オフィスメディカルあるいはMSL経験者をお持ちの方必見です6 - 10 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- A joint venture between two global healthcare companies to provide sustainable solution to pharmaceutical clients as a CSO.
- Responsibilities
- 担当領域のSTL(Scientific Thought Leader)との情報交換を通じて、最適な治療を普及させる役割を担う
メディカルストラテジーの策定
疾患領域の最新情報の提供
領域のSTLからインサイト収集
Medical Unmet Needsの同定
Real World Evidenceの創出や臨床研究の企画及び実施
アドバイザリーボードミーティングや講演会などの企画・実施
最新医学情報の収集と社内関連部署への提供
グローバル関連部署との折衝やコミュニケーションなど
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-27839 Posted: 2025-05-25
【東京／8月以降入社】MSL（血液領域）～豊富なキャリアパス／研修・教育環境充実～
血液領域における経験ある方歓迎6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs
- 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
- 業務内容：
MSLは、 担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズを収集し、育薬に貢献することが主な役割です。
具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。
【具体的役割】
KOL を訪問し、アンメット・メディカル・ニーズやメディカル・インサイトの収集
主催、共催の講演会企画の立案、実行ならびに他部門の支援
医療従事者からの非臨床、臨床研究等の相談対応
Data generation plan の策定と戦略達成に必要なデータギャップの特定
パブリケーションプランの作成
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-14203 Posted: 2025-05-25
【東京】MSL（未経験）
豊富なキャリアパス／研修・教育環境充実6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs
- 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
- 国内トップクラスの規模とプロジェクト受託実績を誇る同社の一員となり、MSL（メデカル・サイエンス・リエゾン）としてクライアントビジネスおよび患者さんにとっての最適な治療法の確立に貢献していただきます。
MSLは、 担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズ（注：未だ満たされていない医療ニーズ、有効な治療方法がない疾患に対する医療ニーズ）を収集し、育薬に貢献することが主な役割です。
具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。
Patrick Chang
Industrial & Life Science -
Job number: JN -052025-188707 Posted: 2025-05-23
プロジェクトマネージャー（PM）日本発のグローバルCRO
製薬業界もしくはCRO業界にて少なくとも8年以上の臨床開発経験が活かせます。9.4 - 14.5 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We specialize in supporting new drug development. Our fundamental philosophy is to consistently provide professional quality in all aspects of pharmaceutical development and to pursue the happiness of our stakeholders, including pharmaceutical companies, medical institutions, patients, shareholders, and employees. Founded by nine members who previously worked on new drug development at a major domestic pharmaceutical company, we leverage our extensive experience in developing drugs such as immunosuppressants to support the entire new drug development process. Currently, in response to the pharmaceutical industry\'s increasing reliance on outsourcing, we have established a system centered around highly knowledgeable and capable CRAs to provide fast and accurate data. Additionally, we have built a global support system for new drug development, using our Japan office as a hub to facilitate international joint clinical trials across Asia, Europe, and the United States. We also place a strong emphasis on employee education, continually enhancing our training systems to ensure ongoing skill development.
- Responsibilities
- 顧客重視のリーダーシップを持ち、PhaseⅠからPhaseⅣまで複数の臨床研究試験を管理する。
グローバルチームと連携し、日本やアジアプロジェクトチームおよび他部門との協業，調整，進捗管理を行う。
プロジェクトのリソースを調整し、契約や予算を遵守するよう管理する。必要に応じてChange Orderを顧客へ提案し、締結するよう調整する。
顧客、グローバルチームやベンダーの要望を考慮し、目標達成するようアクションおよびタイムラインを計画し、管理する。
BidとProposalなど事業開発活動をサポートする。
リスクマネジメントベースで、複数のサイト/国で指摘されている潜在的な傾向に関する最新情報を提供し、上級管理者および顧客とともに防止策について議論する。
PMのラインマネジメントを行い、PMをサポートし指導する
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-188269 Posted: 2025-05-19
ヘルスケア物流の品質管理担当
製薬業界での経験者必見です!5.5 - 8.5 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is an international air and ocean freight forwarder.
- Responsibilities
- ヘルスケア物流の品質管理を担うグローバルチームの一員として、日本および東アジア地域におけるグローバル品質標準の導入・維持・拡大支援
日本および東アジア地域の現地法人の品質部門と協力し、ヘルスケア産業顧客向けの監査対応・ソリューション考察
その他、同チーム所属の欧州、米州、アジア・オセアニア地域の担当者/事業管理部門（Business Unit）と連携も行っていただきます。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-188053 Posted: 2025-05-16
Near Patient Nurse
Looking for a nurse with hands-on experience5 - 6 million yen Nagasaki Pharmaceutical Nurse
- Company overview
- We provide medical and security services, specializing in healthcare, safety, and logistics. Our 24/7 support system spans over 90 countries, ensuring the health and safety of employees worldwide. We offer risk management, emergency support, and consulting services. Our assistance services are delivered by medical and security experts, supporting sustainable business operations by prioritizing employee safety. Our mission is to facilitate safe and sustainable business practices globally.
- Responsibilities
- Main responsibilities:
Key Requirements Near Patient Nurse to be located in close proximity to key locations / MTF
Working under a centralized duty roster system and where applicable, participate in on-call duties which can include weekends plus after hours
Near Patient Nurse to remotely support other TRICARE regions as required such as project work and medical support as required
Mobility requirement with less emphasis on home office duties
Participate in routine MTF meeting/event attendance, regular contact with MTF personnel to discuss medical cases
Perform regular provider visits and inspections, contact with providers to obtain medical updates
Ability to comfortably provide direct face to face plus telephonic beneficiary support
Ability to work proficiently with TRICARE CRM system and provide SOAPe updates within the contractual/internal KPI’s
Ability to manage calls from providers, MTF’s and beneficiaries
Manage case load independently within the Company TRICARE policies and procedures for both prime and prime remote cases
Escalate as required to senior in country Near Patient team members including team leads, physicians and or medical director to discuss/highlight case complexities/challenges
Work together with Quality Assurance Teams to support Quality Assurance initiatives and case specific potential quality incident investigations and events. This will include compliments and complaints plus service recoveries
Medical ResponsibilitiesProvide comprehensive In-patient clinical case management for a Beneficiary. Completing status reports upon admission and according to contractual requirements or acuity whilst the patient remains admitted to the provider. These reports must be reported in English, clinically detailed and accurate according to Company standards.
In the pursuit of medical updates, the Near Patient Nurse may visit the provider, or assist with calling providers or treating doctors for medical information for geographically remote cases as required.
Additionally, be prepared to liaise with PCSPs and beneficiaries, to obtain detailed clinical information including past medical history to allow for accurate on-going case management.
Where the Near Patient Nurse feels care is suboptimal, not necessary, or potentially harmful to the beneficiary the Near Patient Nurse must escalate such matters to the Near Patient Physician Lead, Near Patient Regional Medical Director for discussion.
Upon discharge, support when required with the Near Patient Medical Collection Team to obtain the discharge summary and hospital records from the provider, ensuring that the medical information correlates with the information obtained during admission and update the medical records accordingly.
Provide when feasible on-site beneficiary support services such as ad hoc language support and chaperone services when visiting health care providers.
Establish and maintain the relationships with providers; leveraging these relationships for clinical quality assurance and oversight
Assist with translation and triage of medical reports where necessary.
Support Near Patient Quality Assurance Leads as requested such as obtaining medical records as required
Attend and participate in Company staff meetings, internal and external educational offerings, in order to maintain professional development requirements.
Medical Network Liaison and Quality Assurance ResponsibilitiesBuild positive and effective relationships with local network providers (medical and administrative representatives), and with local TRICARE Point of Contacts and members of US Health Units.
Working with the in country Near Patient Physician Lead as a point of integration/coordination and continuity for the rotationally aligned forces with host nation providers
When require plan, execute and write up site audits, obtaining provider credentials in order to assess and document provider scope, safety and quality of service.
Support the planning of trips with relevant internal and external stakeholders, to support on site provider visits and evaluations.
Undertake evidenced accurate assessments and review of providers including the scope of medical capabilities, the safety and quality of care provided by these providers.
Customer Care and NetworkingBe accessible and responsive to TRICARE beneficiaries , clients and colleagues questions, concerns and requests for information.
Build positive and effective relationships with local network providers (medical and administrative representatives), with local TRICARE Point of Contacts and members of US Health Units, with other internal and external customers and suppliers and ensure continuity of service delivery by providing general customer services to the Organization’s client.
Deal positively with complaints, resolving these wherever possible on a timely basis, and/or referring them to the appropriate department or Quality Manager.
Identify areas where training can improve overall productivity of Company
Elaine Montes
Industrial & Life Science -
Job number: JN -072024-138030 Posted: 2025-05-15
[Brightpath] Oncology Researcher
Pharmacology researcher5 - 9 million yen Tokyo Pharmaceutical Pre-Clinical Trials
- Company overview
- Our client is a biotech venture with the mission of developing cancer peptide vaccines
- Responsibilities
- In vivo / Xenograft antitumor drug efficacy test (mouse), xenograft drug test (mouse), human immune-building mouse drug efficacy test, immunoinduction test (spleen, lymph nodes, peripheral blood)
Ex vivo / cell-mediated immune analysis (FACS, ELISOPT ELISA), antigen-presenting ability evaluation (mouse immune system)
In vitro / cytotoxic activity evaluation, growth suppression evaluation, MLR, etc. (co-culture evaluation), ADCC / CDC
Patrick Chang
Industrial & Life Science -
Job number: JN -052025-187811 Posted: 2025-05-09
信頼性保証リーダー
医薬品品質管理業務（3年以上、バイオ医薬品品質管理業務の経験があれば尚可）をお持ちの方必見です8 - 12 million yen Fukuoka Pharmaceutical Research & Development
- Company overview
- Our client is researching and developing vaccines.
- Responsibilities
- 治験薬ワクチン原薬の信頼性保証のリーダーとして、当社パイプラインの治験薬製造における信頼性保証業務（逸脱管理、変更管理を含む）、及び社内GMP製造体制の構築を行っていただきます。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-187800 Posted: 2025-05-09
精密化学品の品質保証職
医薬品に関する品質保証経験をお持ちの方必見です。5.41 - 9.28 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a trading company that mainly deals in chemical products and physics and chemistry equipment.
- Responsibilities
- マスターファイルの作成及び登録申請（照会対応含む）
製造業の更新申請及び外国製造業者の認定申請
医薬品原薬・中間体、化学品に関する品質保証業務
GMP管理、品質システムの構築及び遂行業務
製造記録・試験記録の照査業務
サプライヤーの監査業務
お客様からの問い合わせ初期対応、並びに一部代理店の管理
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -022025-184715 Posted: 2025-05-07
市場評価・学術業務
医療業界の技術や知識に知見があり、医師との信頼関係を築ける方必見です6 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a major corporation based in Japan, offering a wide range of products and services. Beyond just photographic film and cameras, we also specialize in medical equipment, chemicals, optical devices, and more. Our focus is on the quality, innovation, and sustainability of our products, providing value to customers worldwide. Additionally, we prioritize research and development, contributing to advancements in science and technology.
- Responsibilities
- 内視鏡製品の市場商品性評価と学術活動の推進を担っていただきます。■業務詳細：多くの新製品が上市される中、日本・欧州での新製品の市場商品性評価を推進するため、評価計画立案から評価機関（大学病院等）での訪問評価までを推進する
市場投入された製品の医学的有効性を訴求するため、基幹病院（大学病院等）との研究活動を推進する
Go Ozawa
Industrial & Life Science -
Job number: JN -052025-187693 Posted: 2025-05-07
【東京/大崎】セイフティーフィジシャン（MD）～ノンラインマネージャー or グループマネージャー～
医師資格、臨床医としての経験お持ちの方必見12 - 28 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
- ■役割と目的確かな医学的知識に基づき、この役割は委任された資産（AT）だけでなく、必要に応じて他の製品に対してもローカルの患者安全および薬物安全監視（PSPV）戦略を定義し、グローバルPSPVが提供する枠組みに基づいてクロスファンクショナルチームに利益/リスク（B/R）専門知識を提供することで、患者および/または臨床試験被験者を保護するためのBIリスク軽減戦略の一貫した実施を確保します。
LPSLと共に、ローカルの患者安全医師（PSP）は、ローカルPSPV戦略に貢献し、ローカルPSPVシステムの委任された部分を責任を持って管理することで、高品質なローカルPSPVシステムを確立および維持し、外部規制および内部プロセスに準拠することを確保します。
■責任範囲グローバルBRチームが評価し、グローバルおよびローカルで調整された利益/リスク（B/R）プロファイルの専門家として、J-RMPの準備、適切な薬物使用などの安全確保措置を講じ、エビデンス/資産チームと密接に連携してB/R知識を提供し、ローカルのニーズ/洞察をグローバルチームに提供します。日本特有の要件（例：国別形式）および内容に対応するローカルリスク管理計画の準備をリードします。
グローバルリスク最小化措置の実施と進捗を担当し、委任された資産（AT）だけでなく、必要に応じて他の製品のためのローカルRMPの開発および実施をリードします。適時かつ質の高いPV入力と洞察をローカルラベル文書および教育資料（例：SPC、PIL）に提供します。
委任された資産（AT）だけでなく、必要に応じて他の製品のためのローカル安全データの監視を実施します。BI製品または同クラスの製品に関するローカルソースから得られた関連する新しい安全情報をPVWG委員長に適時に通知します。
利害関係者（例：LRA、法務＆コンプライアンス）と協力して、ガイドラインの準備を含む適切な薬物使用などの安全確保措置の実施を促進します。
必要に応じてすべての致命的/生命を脅かすケースの医学的品質レビューを実施し、適切なフォローアップ措置を定義します。必要に応じて「致命的ケース調査」レポートを完了します。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-143552 Posted: 2025-05-02
R&D Japan/ Group Manager, Innovation Management Office
Alliance / Open Innovation8 - 16 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.
In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.
Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape. - Responsibilities
- All R&D communication physically such as THM and/or virtually such as via e-mail/R&D Portal site etc. R&D regular leadership communication such as RD SLT and LT.
Any R&D responsible technology-based innovation initiatives such as Robotic Process Automation, Cloud based cross functional team communication, as well as center of excellence to shard service provider at R&D. In addition to that the Group will provide service to lead non-R&D specific career development program to whole R&D, as well as to be responsible for new grads program execution.
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-38165 Posted: 2025-05-02
Medical Science Liaison (MSL) - 自己免疫領域
MSL position at global maker with strong pipeline7 - 11 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- 業務内容：
領域専門医等のリクエストに応じて、最新医学・科学情報を提供・議論する。
領域専門医等の意見、疑問、ニーズならびに共同研究などの機会を探索・収集し、社内関連部署と連携して解決策を探る。
サイエンティフックエキスパート(SE)との関係構築および維持をする。
メディカル部門主導イベント（アドバイザリーボード等）を社内医学専門家と協働して実施する。
Yui Osone
Industrial & Life Science -
Job number: JN -072024-30356 Posted: 2025-05-02
【東京】開発薬事※マネージャー候補
薬事部門のマネジメント経験者必見です!7 - 12 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is providing drug development service.
- Responsibilities
- 部門の管理、人財マネジメント
営業活動
部門の予算管理
医薬品・医療機器関連の治験相談
メディカルライティング業務管理
医薬品・医療機器に関する法規制への対応業務
各国申請代理人との連絡・調整
当該国薬事規制等の調査
アジア地域における医薬品・医療機器開発戦略コンサルティング （各種試験成績・資料の評価、医薬品・医療機器承認申請に係る当局対応、申請届出等）
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-35013 Posted: 2025-05-01
医薬品の品質保証
医薬品業界もしくは医療機器・食品・化粧品メーカー等類似技術を使用した業界の品質保証業務経験がある方必見です。5 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a pharmaceutical manufacturer.
- Responsibilities
- 治験薬、医薬品のＧＭＰ、ＧＤＰ管理業務ならびに薬制対応業務
同社で扱う医薬品及び治験薬の製造・品質試験における品質保証業務全般を担当します。製造・品質試験における各プロセスの品質保証業務
逸脱管理、変更管理、CAPA管理、出荷管理
医薬品品質システムの運用推進（教育、文書管理、等）
各工場の知見集約（知識管理）とサイト横断的な医薬品品質システムの構築（共通化・効率化）
新製品や新規設備の技術移転、クオリフィケーション、バリデーション
国内外の当局GMP査察対応
業者管理（原材料サプライヤー等）
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-36041 Posted: 2025-05-01
MSL(メディカル・サイエンス・リエゾン)※再生医療、オンコロジーの豊富な受託実績／年休128日
MSL・MA（メディカルアフェアーズ）経験者歓迎6 - 12 million yen Tokyo Pharmaceutical Medical Affairs
- Company overview
- Our client is providing drug development service.
- Responsibilities
- ■業務内容
医学的、科学的な側面から円滑なコミュニケーションを取り、KOL（Key Opinion Leader）と良好な関係を構築する。
臨床研究や製造販売後調査の立案・作成に関するサポートを行い、そのデータのPublicationを通じて製品価値を高める。
社内・外の関連部署とコミュニケーションを取り、製品ストラテジーに沿った市販後に向けた活動の企画立案。
社内外において医学的、科学的な面から自社製品の適正使用を推進する。
営業部門に対する医学教育サポートなどを行う。
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-137827 Posted: 2025-05-01
Senior Clinical PMS Manager
In charge of all clinical PMS12 - 17 million yen Tokyo Pharmaceutical Clinical Development
- 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
- Accountable for day to day activities of all aspects of the operational management of local post-marketing studies (PMCT and PMS), including study timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
Accountable for the oversight of investigator-initiated studies granted by the company, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
Develop and monitor study budget and timelines
Monitor work to ensure quality
Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
Contribute to the planning and set-up of a study and provide planning parameters
Overseeing external providers, Act as an interface between Global Clinical Operations and local organizations (Global Operations)
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-137826 Posted: 2025-05-01
Senior Manager, Regulatory Manager
Managing two different teams12 - 17 million yen Tokyo Pharmaceutical Regulatory Affairs
- 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
- Effective manage regulatory pathway for Life Science (LS) products and services in Japan, cover the areas of biopharma processing, pharm & food materials (APIs, pharmaceutical excipients, food additives), medical devices, IVDs, equipment/instrument, biologics and animal derived materials, etc.
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising guidance, standards and regulation.
Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition. Definition of processes to implement upcoming regulatory needs and requirements.
Closely work with global/regional regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
Drive, manage and coordinate registration / notification / listing activities in Japan. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
Provide regulatory guidance in risk assessment, identify regulatory impact to the Life Science and provide regulatory recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with regulatory agencies, inspectors and trade associations.
Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -042025-186449 Posted: 2025-05-01
【東京】薬事申請業務（医薬品）◇年休122日／1989年に設立されたCROの先駆け企業
一人ひとりに寄り添ったキャリアプラン6.1 - 7.3 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- -
- Responsibilities
- ■業務内容：原薬等登録原簿（MF）登録申請書/外国製造業者認定（AFM）申請書及び添付資料等の作成/レビュー
MF国内管理人業務及びAFM国内代行者業務、海外製造所との英語でのコレポン（主に電子メール）
医薬品・医薬部外品・化粧品等の薬事コンサルティング
PMDA対応業務（対面助言・簡易相談等支援、承認申請後の照会事項回答作成支援等）
医薬品の承認申請書、CTD（資料概要）、添付資料等の作成/レビュー
医薬品製造販売業/製造業/販売業の許可申請書類作成
Martin Tsvetkov
Industrial & Life Science