Jobs list of Pharmaceutical

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

[Brightpath] Oncology Researcher

Pharmacology researcher

5 - 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

Access Strategy Senior Manager

Senior Manager position at global mega pharma

12 - 18 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: Overview:Develop a compelling access strategy tailored for New Asset to stakeholder interests and needs and leads strategic & tactical planning for market access activities to ensure optimal patient access with appropriate price setting.
Drive a Local/Regional/Global cross-functional team to develop and implement access strategies for assigned assets.
Scrutinize the commercialization plan for the assigned asset from pricing &reimbursement perspectives
Obtain endorsements from TA Leads to implement access strategies.

Main Responsibilities:Develop and implement access plans for assigned assets, which include scenario-based pricing assumptions with strategic initiatives, secure patient access and identify opportunities for accelerating launch timing.
Investigate and build deep understandings of key stakeholders’ (payers, market access customers) needs and reflect these insights into business/access planning processes via leveraging real-world databases and information in the following areas: Epidemiology: Patient dynamics, pathology, genetic background, Diagnosis & treatment guidelines
Market Environment: Current market size, competitive landscape analysis
Physician/Patient/Payer Insights: Unmet medical needs, burden of Disease/QOL
Local/Overseas access environment: Policy, HTA/Reimbursement system

Lead discussions and presentations to senior management to get required funding for launch optimization projects, including HEOR, HTA, RWD based data generation, as well as unbranded campaigns, etc., identified through cross functional discussion.
Work in close alignment and cooperation with a cross-section of colleagues (Global Access & Value, Global Commercial Development, Global Medicine Team, MA, DJ, Business Unit, A&V, P&PA, and BAI) through JMT/JVT/JAT.
Participate in JDC/J-PRC for portfolio entry, Global DP3 and Japan buy-up etc. through asset assessment in related TA as required.
Develop and include value claims for the brand at NDA to support optimal access.
Support NAA on developing reasonably accurate Long-rage revenue/expense/demand forecast for company pipeline assets and BD projects until 18 months prior to approval.
Support NAA on developing data, insights and recommendations for Strategic Plans that include strategies, tactics, and programs to maximize the long-term potential of development compounds, and obtain senior management endorsement.

GCP監査

GlobalのQA組織に所属していただきます

6 - 1.1 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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：
GCP（臨床試験）領域における監査担当者として、医療機関監査、総括報告書監査、TMF監査、ベンダー監査、システム監査、などのGCP監査を計画・実施し、監査報告書を作成し、監査所見に対するCAPA（是正・予防措置）管理を行う。
さらにCSV（コンピュータライズドシステムバリデーション）領域の経験があり、希望すれば、CSV監査も行う。
監査対象地域：グローバル（欧米・アジア・日本等）

エビデンスジェネレーション

製薬企業、CROまたは研究機関において、5年以上のスタディマネジメント経験をお持ちの方必見です。

7 - 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: 企業主導で行う研究プロジェクトにおいて、研究プロジェクトマネジメントを行い、計画に則ったエビデンス創出に貢献する。
研究者及びその所属研究機関、米国本社、社内関連部門（メディカルアフェアーズ、研究開発本部、法務・コンプライアンス部門など）との協働により、研究者の独立性・研究の中立性を保ちながら、研究者主導研究支援のオペレーションを管理・実行し、日本の研究者による革新的なエビデンスの創出を支援する。

HEOR担当

医療経済評価モデル、観察研究、PRO/QOL研究の経験をお持ちの方必見です。

5 - 12.6 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: AT/eELとの連携により資産価値を最大化するための証拠生成戦略を策定し、現地のニーズを企業の資産戦略や成果物（AEP、IAPなど）に反映します。
HEOR 戦略に関する責任ある資産の取り組みについて、部門を超えて議論し、RWE 生成を含む HEOR 研究を主導します。
研究計画、医学的執筆、出版資料、結果の普及を含む、証拠生成の全プロセスに責任を負います。臨床開発における有用性を含むCOAの評価、企業AT/企業HEORとの連携によるCOAツールの検証または新規開発

DXデータサイエンス

DX部門やデータサイエンス部門の組織長になれるチャンスがあります。

8 - 12 million yen Tokyo Pharmaceutical Data Management / Biostatistics

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：
当社グループのGen-AI技術導入・応用における中核リーダーとして課題創出、分析、解決のリード。
Gen-AI技術を応用したビジネスケースの企画、計画立案・活用。
Gen-AI技術を応用することによる、データ活用の業務スコープの拡大。
Gen-AI技術の活用による課題解決のけん引。
Vendor企業との提携、協業。
「advocate」として社内への生成AIの浸透を推進する役割。

【東京】メディカルライター（医薬品の臨床開発関連文書の作成業務、QC等）

メディカルライティング実務経験者必見です!

5.5 - 9 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.
Responsibilities: メディカルライティング業務をお任せ致します。主に、医薬品の臨床開発関連文書の作成業務、QC等をお任せする予定です。

【具体的には】
関連部署及び外部業者との調整、進捗及びスケジュール管理
臨床開発関連文書作成 (試験実施計画書、同意説明文書、治験薬概要書等、治験総括報告書、CTD等)
開発関連文書作成時のQC等

医薬品の品質保証 <業界経験不問>

年休124日／住宅手当など福利厚生も充実◎

5 - 8.8 million yen Saitama Pharmaceutical Quality Assurance / Quality Control

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: 以下のとおり、製造販売業者の品質保証活動をサポートしていただきます。
【職務内容】
GQP 品質保証活動を確実に実施し、確立された方針／手順、グローバル要件、および適用されるすべての規制の範囲内で活動が行われるようにする。
GQP業務をサポートするための強固な現地手順を確立し、維持する。
製造現場を管理し、製造現場と緊密に連携して、効果的で強固な品質マネジメントシステムが実施されていることを確認する。
グローバル部門を含むオペレーション部門および技術部門との強力な連携により、製造所の逸脱、重要な調査、変更管理を製造販売承認保持者として管理する。
規制当局への申請更新や新製品の申請・上市に伴う変更管理活動をサポートする。
ギャップ是正を含む製造拠点の定期的なGMP監査をサポートする。
製造拠点の年次製品レビューのレビューをサポートする。
日本薬局方やその他のコンペンディアルの更新や変更に伴うコンプライアンス活動をサポートする。
規制要件および規制通知に関連する品質およびコンプライアンス活動をサポートする。
新規外部パートナーの事前承認のための品質デューデリジェンス活動を実施する。
様々なビジネス取引における品質活動をサポートし、外部パートナーと関わる。
製造販売承認更新のためのGQP規制検査をサポートする。
薬事、ファーマコビジランス、現地およびグローバル製造拠点を含むステークホルダーと機能横断的に協働し、製品のコンプライアンスと安定供給のためのGQP活動をサポートする。

薬事監査

製薬メーカーまたは商社において、上記業務内容のすべてもしくはいずれかの実務経験をお持ちの方必見です。

5.5 - 7.5 million yen Chiba Pharmaceutical Regulatory Affairs

Company overview: Our client is a manufacturer of active pharmaceutical ingredients.
Responsibilities: 外国製造業者の管理に関する事項
国内管理人業務に関する事項（原薬）
製販の承認申請に伴う照会事項対応に関する事項
製販の一変等に伴う照会事項対応に関する事項
MF/CTD作成と管理に関する事項
DMF作成と管理に関する事項
ASMF作成と管理に関する事項

CRA/Senior CRA

Both RA and Clinical work

8 - 11 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC
Responsibilities: Clinical Development Operations:
Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
Primary point of contact of trial sites with regards to the conduct of the study/ project
Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
Ensure that the sites are adequately trained on the protocol and other study specific requirements
Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
Track site budget and payments
May be involved in preparation of status reports for clients
Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
Act as mentor/coach to more junior staff as necessary
Travel as necessary according to project needs
Perform other duties as assigned by line manager.

Regulatory:

Ensure study start up processes are done according to applicable SOPs and regulatory requirements.
Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)
Ensure that product labels are compliant with applicable regulatory requirements
Collect and submit necessary documents for study drug importation, return and/ or destruction
Ensure that all documents necessary for site activation are collected

Learning Lead | ラーニングリード

Enhance performance capability and ensure compliance

12 - 17 million yen Tokyo Pharmaceutical Business Development / Alliance Management

Company overview: We are a global pharmaceutical company that develops, manufactures and globally markets a wide variety of pharmaceutical products. We are particularly strong in the areas of gastrointestinal, cardiovascular, central nervous system, immunology, and other disease areas, providing innovative medical solutions. We promote sustainable medical innovation to improve the health of patients and the quality of healthcare. The company is also committed to social responsibility by focusing on community involvement and sustainable corporate activities. Through aggressive investment in research and development, as well as product development from a global perspective, the company contributes to the advancement of healthcare around the world.
Responsibilities: The primary purpose of this position is to work with the Site Quality Systems & Compliance Lead to develop and maintain the site's GxP learning system to build and enhance performance capability and ensure compliance with global standards for training within GMSGQ.The Site Learning Lead is responsible for establishing the site's GxP learning plan based on a robust training needs analysis, providing operational competency requirements for the GXP regulated manufacturing environment across multiple departments, and implementing the GMS learning strategy based on the site's needs and business objectives.In collaboration with Quality Systems personnel responsible for overseeing GMP training, oversee the implementation of the Global Training Policy and GOPs to ensure efficient, effective and adaptable learning systems are in place to meet the needs of the sites. Be responsible for managing the ongoing deployment and use of the LMS (Learning Management System) platform including associated application management and deployment.You will also work with the appointed Global Learning team business partner to ensure robust learning system elements are in place and appropriate technological learning solutions are provided for site use. You will be responsible for overseeing the training quality system elements from the site quality perspective, following the site standard structure and reporting to Business Excellence at the site level for training.
Main responsibilities:
The core purpose of this position is to develop and maintain the site GxP Technical Learning system to build and enhance performance capability and ensure compliance with Global standards for training within GMSGQ (Global Manufacturing & Supply and Global Quality organizations) in partnership with Site Quality Systems & Compliance Lead.
The Site Learning Lead is responsible for establishing the site GxP learning plan, based on robust training needs analysis to deliver the operational competency requirements for a GXP regulated, manufacturing environment across multiple functions and for implementing the GMS learning strategy based on site needs and business objectives.
They oversee the implementation of global Training policies and GOPs (Global Operating Procedures) to ensure an efficient, effective, and compliant learning system is in place to meet site needs, in partnership with Quality Systems colleague with responsibility for GMP training oversight.
Responsible for managing the continued deployment and use of LMS (Learning Management System) platforms, including administration and delivery applications.
The Site Learning Lead works with their assigned Global Learning Team Business Partner to ensure robust Learning system elements are in place and appropriate technical learning solutions are provided for site’s use.
As per the Standard Site Structure, Training reports to Business Excellence at the site level, with oversight of the Training Quality System element from Quality at site.

【埼玉】CMC薬事　CTD作成担当者

CMC関連部署での勤務経験者必見です!

7 - 12 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: 医薬品のライフサイクルにおけるCMC薬事業務・資料（IND／IMPD、新規申請、変更申請、Annual／Renewal資料、照会対応）についてレビュー又は作成
承認・登録情報の維持管理
GMP証明書・製剤証明書の発給申請
薬事規制・レギュレーション情報の収集及び活用
上記業務について効率化及び改善活動含む
必要に応じて国内外の上記薬事業務について、関連部門とのコミュニケーション

統計解析プロジェクト責任者候補

グローバルカンパニーで幅広い経験を積めるチャンス（治験から市販後まで）

5 - 8 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: Our client is a pioneer and leading CRO contract research organization.
Responsibilities: 医薬品・医療機器の開発（治験）から製造、販売後の調査における統計解析および、リアルワールドデータを用いた統計解析まで、総合的な医薬品・医療機器開発支援事業における統計解析業務を行います。薬医薬品・医療機器の有効性・安全性を統計学により適切に評価して、科学的根拠に基づくエビデンスを構築するために、高い統計解析の知見を活かしてプロジェクトを推進していただきます。入社後は、ご経験を踏まえた業務をお任せします。経験の浅い方は、社内外の充実した教育カリキュラムを通じてスキルを向上させ、徐々に担当できる業務の幅を広げ、統計解析の専門性を深めていただきます。
業務内容：
通常プロジェクト『解析計画の立案』統計解析計画書や解析帳票レイアウトを規定するモックアップ作成
『解析用データセット作成』データマネジメント部門から受け取ったデータをSASで加工し、解析用データセット作成
『CDISC対応』 CDISC関連ドキュメント作成、SDTM・ADaMデータセット作成
『解析帳票作成』統計解析計画書に基づき、様々な解析手法を用いてSASにより解析結果を出力

上記以外で発生する業務『統計コンサルティング』統計の専門知識を活かした様々なコンサルティング業務提案（症例数設計、プロトコールの統計パート作成、PMDA相談対応など）
『薬物動態解析、母集団薬物動態解析（PPK）』専門のソフトウェアを用いた薬物動態パラメータの算出、母集団薬物動態解析など
『自社開発業務』グループ会社にオーファンドラッグを扱う製薬会社をもつため、自社製品の開発または調査に統計解析担当として参加できる可能性があります。

PMS推進担当者

PVおよびPMSにおける5年以上の経験PMSモニタリングの経験をお持ちの方必見です。

6 - 11.5 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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: PMS業務を推進いただきます。データ収集、進捗追跡、予算追跡、ベンダー管理などのGPSP運用活動を主導/管理します。
GVPおよびGPSP規制に準拠した安全仕様に基づく追加のPV計画として市販後調査研究を実施
グループメンバーの育成や予算管理などの経営活動に貢献

Senior Manager, Regulatory Manager

Managing two different teams

12 - 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.

Senior Clinical PMS Manager

In charge of all clinical PMS

12 - 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)

【東京本社】CMC薬事 CTD作成担当者

CMC関連部署での勤務経験者必見です!

7 - 12 million yen Tokyo 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: 医薬品のライフサイクルにおけるCMC薬事業務・資料（IND／IMPD、新規申請、変更申請、Annual／Renewal資料、照会対応）についてレビュー又は作成
承認・登録情報の維持管理
GMP証明書・製剤証明書の発給申請
薬事規制・レギュレーション情報の収集及び活用
上記業務について効率化及び改善活動含む
必要に応じて国内外の上記薬事業務について、関連部門とのコミュニケーション

マーケティングリサーチ（プロジェクトリーダー候補）

豊富な実績とノウハウあり／実力に応じてマネジメント層へ早期キャリアアップも可能

8 - 12 million yen Tokyo Pharmaceutical Marketing

Company overview: We are a marketing consulting firm specializing in the pharmaceutical industry in Japan. In particular, we collect and analyze health data and develop diagnostic support systems for medical and research institutions. We utilize cutting-edge artificial intelligence (AI) technology to achieve advanced processing and utilization of medical information. We also promote the effective use of clinical data with the aim of improving the quality and efficiency of medical care. Furthermore, we provide platforms to support patient health management and develop solutions for the digitization of healthcare. In collaboration with medical experts, we are developing innovative services based on the latest medical knowledge and contributing to the development of the healthcare industry.
Responsibilities: 同社マーケティングリサーチ事業のマーケティングリサーチ担当（プロジェクトリーダー候補）として、以下の業務をお任せします。

■業務内容：
定量・定性調査の実施・分析等を含め、クライアントである製薬・医療業界企業の商品開発～上市前後のプロモーション業務まで、リサーチ・マーケティング戦略立案から、顧客の中長期的な成長・関係構築に向けたコンサルティングを行います。
クライアントに対して長期的な提案活動まで可能であるため、成果をフィードバックしながら効果検証を続け、顧客のパートナーとして長期に渡るフォローを行っていきます。
製薬企業のニーズに基づいた、医師／薬剤師／患者様に対する情報収集、分析、課題抽出、改善策の提案などもお任せします。

■業務の特徴：
医薬品分野の市場調査を年間700プロジェクト以上実施しており、豊富な実績とノウハウがあります。
実力に応じてマネジメント層へ早期キャリアアップが可能です。
夜間や休日にインタビューを実施する場合の午後出社や振休など、裁量をもって柔軟に勤務することが可能で、長時間勤務にならないような時間管理も行っています。

■入社後のキャリアについて：
これまでの経験を通じて、自ら医療業界における事業を推進する、新規事業を創造する中心的役割を担う機会があります。
マネジャーのポジションでは１つの組織を事業運営する立場に立つため、事業開発・経営感覚を身につける等非常に貴重な経験を積むことができます。

Medical Manager

Strategy planning and data gathering

13 - 17 million yen Tokyo Pharmaceutical Medical 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: STRATEGY:
Act as Local Medical Affairs TA expert in one or more TAs
Support the Brand or launch teams/ Local TA leadership team in the development of TA, Launch and Brand strategies
Lead Medical Affairs activities in assigned territory along defined local Medical Launch / Brand strategies
Consolidate and communicate trends, market insights, and unmet needs identified in the field

OPERATIONS:

Develop Medical material, review marketing material, trainings
Ensure scientific and clinical accuracy for specific product or brand
Receives adverse event reports and transmits such reports internally according to Company procedures
Ensures timely completion and up-to-date knowledge of Company policies / SOPs, and local laws and regulations
Maintains up-to-date GxP knowledge by following internal and external trainings
Conduct Local internal scientific training and ensure continuous Medical education of existing teams and new employees working in the Local TA
Develop Medical KTL development plans
Positively impact external perceptions and knowledge regarding company and company products
Maintain and demonstrate comprehensive and in-depth scientific TA knowledge when executing assigned tactics
Ensure operational excellence by sharing best practices
Map treatment landscape and medical environment for new indications/ programs
Provide support in the planning and tracking of the (TA-specific) medical budget

DATA GENERATION AND DISSEMINATION:

Lead/ support (depending on nature of study) Medical studies, assist to coordinate Local clinical projects and contribute to site selection for clinical projects
Lead Local publication process, publication dissemination and alignment with Local, Regional and Global publication plan
Act as a resource, liaison and facilitator for ISS and investigators that are aligned to the Medical Affairs strategy
Coordinate with ClinDev and ClinOps in providing field support for research studies and assist in the selection of clinical study sites
Assimilate, process and share medical information with stakeholders

STAKEHOLDER ENGAGEMENT:

Provide training to HCPs and support in realising Medical educational events
Interact with Local stakeholders in Medical community in TA
Identify and interact with influential members of the Medical community (HCPs/external experts) and other healthcare stakeholders (managed care organisations, government organisations, patient groups) within assigned territory and TA
Represent company at Medical Education events, programs, meetings and support patient advocacy related activities
Partner with external stakeholders to develop innovative solutions
Engage with internal colleagues (Medical Affairs department, Clinical Operations, Commercial colleagues as appropriate, etc.) in developing and delivering and participating in Medical or cross-functional initiatives

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