「派遣型CRA」について知る 1 ~ 派遣型(外部就労型)CRAから、製薬会社を目指すというキャリア ~
CRAの働き方としての「派遣型=外部就労型」。実は多くのメリットがあるのにあまり知られていません。その業務内容やメリットを説明します。
武田薬品工業株式会社、アステラス製薬株式会社、第一三共株式会社、ファイザー株式会社等
医薬品は一般消費者が直接、薬局やドラッグストアで購入できる「一般用医薬品」と医師の処方箋が必要な「医療用医薬品」に分けることができます。医療用医薬品の中で新規の薬効成分をもつ医薬品を新薬(先発医薬品)といいます。新薬の研究開発から製造販売まで行っている会社を先発医薬品メーカーといいます。そして、先発医薬品メーカーの使命は治療方法がない、あるいは十分な治療方法がない疾患に対し新薬を創出することです。
そのために、薬に関し、研究開発、製造、販売、販売後の安全管理などを行っています。
◆研究開発
基礎研究・・・医薬品開発は植物や微生物由来の物質からの抽出や合成、最近はバイオテクノロジーや遺伝子などのさまざまな技術を活用して、新規の有効成分(物質)=医薬品候補物質を作り出すことを言います。
なお、疾患が発現する機構を解明することで、どのように作用する薬を作ればよいかという研究もしています。
非臨床研究・・・医薬品候補物質を対象に、培養細胞や動物でその物質の有効性や安全性をGLPに則って試験します。試験には薬物動態試験(吸収・分布・代謝・排泄)、薬効・薬理試験、安全性試験(毒性試験)というのがあります。
臨床試験(治験)・・・非臨床試験で有効性や安全性を確認後、実際にヒトに効果があるかどうかを調べる臨床試験(治験)を行います。
◆製造
規制当局からの製造・販売承認を得て初めて販売用の医薬品の製造が可能となります。
医薬品は人の体内に入り生命に関係する製品であるため、徹底した設備・品質の管理(規格から外れた不良品の排除)が求められます。そのため、GMPというルールを遵守して行うよう定められています。
◆販売
自社の医薬品を適正に使用してもらうために、MR(医薬情報担当者)が医師・薬剤師等の医療関係者に対して、医薬品の有効性・安全性・使い方等の情報を提供します。
◆安全性管理等
臨床試験(治験)で新薬の安全性は確認されていますが、限られた範囲の患者(年齢、性別、合併症、併用薬等)での試験ですので、実際の臨床現場では治験で対象でなかった方にも処方されます。その結果、臨床試験ではわからなかった副作用が発生することは想像に難くありません。そういった副作用などは早期に発見し、医療関係者に報告し、同様の副作用が発生しないよう慎重に投与してもらうなどする必要があります。そのために、製薬会社は法令に基づき、市販後調査やファーマコビジランス活動を行い、市販後も日々、薬の使われ方を確認し、医薬品が安全に使われるよう活動しています。
1.日本市場の魅力の低下とグローバル化
国内医薬品市場は少子高齢化により、医療費が増加傾向しており、歯止めをかけるために規制当局は薬価引き下げを強化しました(2年に1度の薬価改定が2021年より一部製品は毎年改定)。それにより薬剤費の抑制を行っています。そのため、外資製薬会社は日本市場を重視しなくなり、例えば日本での治験・承認申請を行わないといった選択をすることも増える傾向にあります。その傾向は、海外展開に注力する国内大手メーカーも同様で、会社によっては国内のMRをほぼ半減させ、海外での販売に注力しています。
また、創薬の面でも、自社創薬からバイオベンチャーやアカデミアが持っているシーズや技術を取り込むという流れが主流となり、その結果国内大手メーカーはR&Dのヘッドクォーターを、バイオベンチャーやシーズの情報が集まるアメリカに置くようになっています。
以上から、「グローバル化」は製薬業界における重要なキーワードとなっています。
2.難治疾患と新しいモダリティへのシフト
糖尿病や高血圧などのいわゆるプライマリー領域と言われる疾患におけるアンメットメディカルニーズは、現在多数出ている製品でかなり満たされたと言われています。
そこから、多くの製薬会社は、がんや希少疾患など難治性の疾患領域をターゲットにするようポートフォリオを大幅に変化させてきました。
また、難治性の疾患ゆえに技術面でもこれまでにないもの求められ、モダリティの面でも免疫療法、再生医療、遺伝子治療など画期的だが高い技術が必要なものにシフトしつつあります(もちろん、この背景には、バイオ技術や、遺伝子解析をおこなうためのコンピューター科学の大幅な進展など基礎技術の進展も大きく影響しています)。
3.医療ビッグデータとペイシェントジャーニーへのアプローチ
多くの医薬品が世の中に流通し、競争が激化するなかで、従来の「モノづくり」を行うメーカーを超えたビジネスを展開する製薬会社が徐々に出てきています。
競合との差別化のために、薬の投与=治療段階だけでの貢献ではなく、ペイシェントジャーニー全体に対し、関与・貢献していこうという流れがあります。例えば、早期の疾患(の可能性)の発見のための診断についての研究、アプリを配布しての患者さんの日々の治療行動の管理・促進などです。
また、このような背景には、医療ビッグデータの整備が進み、活用できるようになり、それら医療ビッグデータから、患者さんの受療行動などがよりリアルに把握できるようになったというものが例として挙げられます。
また、服薬している患者さんがアプリを利用してくださることで、さらにデータが集まり、薬の投与段階に限らずペイシェントジャーニー全体のなかでのアンメットメディカルニーズがより詳細に把握され、製薬会社は新たな貢献を検討するというサイクルになっています。
以上のような業界動向から、
に関し、採用意欲は旺盛です。
一方、製薬業界の職種として大きな割合を持つMRに関しては、日本市場では減少傾向です。ピーク時に6.5万人超いたMR数は、2022年には5万人を割っています。上記業界動向からみても、今後この傾向はさらに加速され、MRに関しては今後も定期的なリストラ(人員削減)がおこると思われます。
国内医療用医薬品生産額推移

※厚生労働省「令和3年薬事工業生産動態統計年報の概要」を基に、insprie株式会社で作成
業務内容 - 医薬品(注射剤)製造業務 - 上記製造業務に付帯関連する業務(準備・片付け・清掃など) ※業務具体例 - クリーンルーム内での製造機器の操作(洗浄機、滅菌機、充填機など) - 使用する器具・部品の洗浄 - 製造環境の清掃、消毒 - 用水設備、空調設備の維持管理 - 標準作業手順書、作業記録書の制改訂などのパソコン業務 - 医薬品製造のために必要な教育の受講
募集中
ACCOUNTABILITIES This position will report to the Head of Global CSR and is responsible for the project management of Global CSR Program and supporting the effective execution and tracking of day-to-day duties of its ongoing projects. Responsibilities include: Lead and manage Global CSR Program project planning, work plan development and monitoring, and reporting to ensure effective communications between program partners, the Global CSR team, and involved internal stakeholders. Coordinate routine reporting and monitoring of Global CSR Program partners, track progress and reporting on results (including outcome data), manage payment process and donation usage reviews, help identify and mitigate risks, and help resolve conflicts and issues. Ensure that a result framework for managing results is in place and regularly tracked for each new Global CSR Program project by closely working with Global CSR Program partners. This includes how the project contributes to sustainable impact, by defining outcome and output indicators and establishing baselines at onset and tracking progress towards targets. Contribute to further development of a result framework towards tracking and demonstrating by data the effectiveness and impact of our Global CSR Program Support the day-to-day management of Global CSR’s Digital CSR Donation Management System, an online portal used to receive proposals and coordinate reporting and monitoring of ongoing projects. Develop contents to demonstrate Global CSR Program partners’ impact using data, and collaborate closely with corporate communications teams to help develop regular and ad hoc project communications for internal and external audiences. Lead coordination of employee participation programs, online and onsite, to create learning and engagement opportunities for employees and support other employee engagement activities as part of the team. Support to Global CSR Program Request for Proposal (RFP) process, including serving as a proposal reviewer, with particular attention on evaluating applicant and shortlisted proposal budgets, and supporting the proposal budget and narrative clarification process, due diligence process, and donation agreement completion and awarding process with internal partners and awardees (as needed). Contribute to the design and drafting of research findings, publications, project updates, tool kits, guidance documents, presentations, and reports, as needed. Assist in the development of project communications for leadership. Support the Head of Global CSR to pursue opportunities for collaboration with other internal teams, helping to build a cross-cutting approach to global health work. Support the Global CSR team with additional tasks as needed. We are seeking a highly motivated, results-oriented individual with strong problem solving and analytical skills to support the Global CSR Program. This role entails working with an entrepreneurial, self-motivated mind-set. The candidate must be able to function independently, be flexible, and have strong commitment to excellence. This will involve attending calls and meetings with leadership, tracking action items and requests, and developing technical materials as needed for meetings and presentations, partnering with others internally and externally to resource various activities and ensuring appropriate follow up. We strive for a strong team environment, working in tandem with internal stakeholders within the enterprise, from finance and legal to corporate communications teams to execute our Global CSR Program. The Manager is a critical member of Global CSR’s lean, agile and dynamic team. A successful candidate will have a background/ interest in global health and philanthropy, be proactive and detail oriented with exceptional organizational, problem-solving, decision-making, analytical and communication skills. This role will rely on strong skills in building collaborations, partnering with broad stakeholder groups, working across global projects and teams, result management, clear communication (verbal and written), and strong time and people management. This role will also require using and embracing of data and technology. A successful candidate will be required to develop strong relationships with a variety of stakeholders, internal and external partners, and effective interactions with senior audiences. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise We seek experienced professionals with a Bachelor’s degree and at least 5+ years of experience, preferably leading projects with expanding scopes of responsibility. Relevant work experience in roles focused on developing, implementing, and managing projects/programs. Broad understanding of global health/development issues and some global health/development experience is preferable. Experience in philanthropic grant management is a plus. Leadership Capable of influencing without ultimate decision-making authority, and gaining buy-in from various stakeholders to ensure successful implementation of programs. Able to understand all the shifting components of a project and what each entails while keeping the big picture front and center Demonstrated strength in structured problem solving, with the ability to easily identify and communicate frameworks to facilitate decision-making. Ability to work in a self-guided manner, and manage multiple priorities with demanding timelines. Ability to question and challenge colleagues including managers and partners in constructive manner. Accustomed to highly unstructured and ambiguous situations; ability to proactively resolve. Interaction Interacts with ease and appropriate discretion with key internal & external stakeholders (members and senior leaders in Global Corporate Affaurs, in other Business Units / Functions and senior representatives of non-government organizations, etc.) Innovation Demonstrated ability to think creatively to ensure successful management of results and completion of programs/ projects. Demonstrated ability to translate strategic and technical content from conversations into high-quality presentations and written communications in the framing and voice of a principal. Ability to think creatively to help organize information, manage workflow, and improve systems and processes. Ability to embrace data and technology Complexity An ability to execute efficiently across a wide variety of tasks and projects simultaneously. Excellent organizational, facilitation, oral, and written communication skills. Ability to work effectively and with sensitivity across barriers such as language, culture and distance. Excellent listening skills and compassion.
募集中
ACCOUNTABILITIES: Working closely with the Head of GIRM and other team members, participate in further developing a high-quality global insurance & risk management function considering all insurance and operational risk management needs of a global company. Participate in and lead insurance projects and assigned insurance programs (such as Directors and Officers Insurance) Support independently local Japanese subsidiaries in insurance related queries according to Global Insurance Guidelines Develop and maintain sound insurance reporting procedures and systems for collection and maintenance of underwriting information needed for e.g. renewal of local/ global insurances Responsible for assigned global insurance programs dealing with complex negotiations with (international) insurance companies and brokers on terms and conditions Take part in defining the scope of work for the insurance brokers who will assist us in order to acquire the most optimal insurance solutions for global insurance programs Maintaining relationships with insurance brokers (particularly those situated in Japan), industry consultants to develop, implement, maintain and update insurance risk management policies, procedures and programs to meet the company's changing environment. Support the global business on contractual risk management reviews and determine appropriate types and level of insurance. Responsible for the identification and assessment of risks to property, personnel, and ongoing business activities in general. Responsible for collection and review of critical underwriting data and preparation of insurance submissions for the assigned global insurance lines and participate in renewal negotiations. Prepare documentation on the assigned insurance lines for decision making on renewal activities by Senior Management Responsible for reviewing the assigned insurance policies for accuracy, recommending appropriate loss retention levels (deductibles, self-insurance levels, etc.) and negotiating insurance coverages, provisions, and premiums in the insurance markets. Support and work closely with other departments in the development and implementation of risk management actions relevant for the insurance lines mentioned Oversee the proper handling and settlement of claims for the assigned insurance lines Support GIRM colleagues with their assigned insurance lines per request Maintain Japan LOC network relationship. Participate in Risk Engineering especially for local sites. Responsible for local CAPEX stand-alone project insurances Maintain the relationship with Japan’s partner insurance agent
募集中
ACCOUNTABILITIES Serve as the Platform Operations Manager. Ensure service delivery teams use approved GDD&T tools and methods when delivering services to customers. Influence the existing complex landscape and solutions by innovating, redefining and simplifying process and technology designs, propose and execute solutions to identified highly complex IT pr Ensure service delivery teams use approved GDD&T tools and methods when delivering services to customers.oblems or process driven agile approaches. Drive the Platform Operations by creating, monitoring and adapting the processes and metrics for the products and platform. Owns the processes around Platform support, including monitoring and alerting, as well as escalation and post-mortem processes. Owns the 24x7 platform operations management and relationship with ICC/ICS and operations outsourced provider. Support the platform team to Introduce new capabilities, delivering business outcomes, in terms of speed to value and mean time to repair as well as client satisfaction. Ensure advanced capabilities are in steady operation, using scripted infrastructure and automation techniques. This will require collaborate with existing teams who currently manage our deployments to maintain a proper production system. Work independently on tough problems with other team members and independently solve, with some guidance, very difficult technology problems. Demonstrates advanced tooling and techniques to other technical organizations throughout the company. CORE ELEMENTS RELATED TO THIS ROLE Provision, manage and maintain the infrastructure that supports plaform and the customers. Identify and execute improvement actions for platform operations, including championing exploration and incubation of advanced technologies. Track, manage, and communicate platform operations performance. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Work independently on highly complex problems with other team members and independently solving, with some guidance, very difficult technology problems. Demonstrates advanced infrastructure tooling and techniques to others across the rest of IT. Demonstrated in depth knowledge of key patterns and industry awareness of trends in the bio/pharma industry with a specific focus on Patform operations. Leadership Ability to manage direct reports and influence ICC/ICS and 3rd party providers to deliver at appropriate levels of quality, response times, stability and agility. Ability to manage and influence the general platform community across to a modern ecosystem. Align and Drive agile and platform driven operations groups to a better end-state. Decision-making and Autonomy Ability to drive our third-party support teams to maintain a stable analytics ecosystem. It will require the need to make tactical decision when needed to our operational environments. Ability to work through/complex and propose proper technology choices. Independently manage day to day operational issues while knowing when to escalate more critical problems or decisions in the environment. Interaction Interact with and influence cross functional team members, including Platform teams, Functional Leads, Business Partners, Product Owners and others. Coordinate and oversee plafform architecture, engineering and delivery teams at a technical level and coordinate different technical aspects across the ecosystem. Align with Enterprise Architecture, Platform Team and Quality Teams to make sure services co-exist with other best practices and deployments. Complexity Ability to distill complex operational feedback into actionable strategies, implementations and stable deployments. Ability to have an agile time-based delivery team operate within a traditional project and waterfall-based funding and approval cycles. Drive complex deployments to implementation and deployment. Many of these solutions are difficult to make stable at scale.
募集中
「派遣型CRA」について知る 1 ~ 派遣型(外部就労型)CRAから、製薬会社を目指すというキャリア ~
CRAの働き方としての「派遣型=外部就労型」。実は多くのメリットがあるのにあまり知られていません。その業務内容やメリットを説明します。
CROと製薬会社で、CRAは何が違うのか? 製薬会社のCRAで内定を得るには?
CROから製薬会社への転職に成功された方へのインタビューです。CROと製薬会社でのCRA業務、臨床開発業務の違い、製薬会社の選考を通過するポイントなどを伺いました。
メディカル関連採用企業主催 求職者向けイベント 2025年11月21日更新
メディカル関連採用企業主催の、求職者向けイベント(職種説明会等)を、定期的に更新してお届けします。
明確に減少傾向にあるMRの状況と、今後の転職・キャリアの方向性
「このまま続けて大丈夫?」と悩み、転職する方が増えているMR。キャリアプランに悩んでいるMRへ、業界の将来性や検討可能な転職先についてご紹介します。
臨床試験データと臨床実態との乖離~製薬会社のマーケティング部門の葛藤~
メディカル専門の人材紹介業を営むなかで、日々製薬会社の臨床開発の方やマーケティングの方からお話を伺うなかで、両者の視点や意識の違いがなかなか大きいということを実感します。そこで、マーケティング部門の視点から、臨床試験(データ)がどう見えているかご案内をさせていただきます。
医師(臨床医)の転職/キャリア 1.企業等での業種/職種の選択肢
臨床以外のキャリアを考える医師が増えてきています。どんな業種・職種で医師の募集があるかを、医師の企業への転職を支援してきた転職エージェントがご説明します。