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業務内容
”Associate Principal Scientist Clinical Research, Oncology Scientific Affairs (OSA), Oncology Science Unit (OSU), Japan Development (JD)”

OSA Strategy and Roles/Responsibilities
1.Scientific Leader (SL) Engagement:
A)Proactively deliver non-promotional and unbiased scientific information to SLs by leveraging corporate R&D and company resources.
B)Conduct competitive scientific/medical and industry competitive intelligence (CI) and provide insights to the corporate R&D and the company.
C)Develop, update and implement strategically oriented site/SL engagement plan in collaboration with global and local R&D functions.
D)Develop, update and maintain SL list by utilizing a relevant system.
E)Proactively engage internal stakeholders to enable SLE in productive manners.
F)Explore scientific collaboration opportunities with academia in collaboration with corporate R&D functions.
2.Evidence Generation:
A)Identify investigator initiated study (IIS) opportunities in oncology pre-clinical, clinical and translation areas, and lead/facilitate required processes including but not limited to pre-review, review, communication of corporate R&D and company decisions, contracting with investigators and follow up in collaboration with corporate R&D and company functions.
B)Lead, facilitate and support LDG by collaborating with corporate R&D and company functions.
3.Publication Support and Management:
A)Manage the development, tracking and update of Publication Plan
B)Support/Coordinate globally lead congress presentation and publication according to the Publication Plan in collaboration with corporate R&D and company functions.
C)Manage locally lead congress presentation and publication according to the Publication Plan in collaboration with corporate R&D and company functions.
4.Congress Support:
A)Plan and organize on-site scientific/medical CI.
B)Manage OSU post-congress reporting process in OSU.
C)Manage and coordinate on-site SL engagement in accordance with the OSA SL engagement strategy and plan by collaborating with corporate R&D and company functions.
5.Medical Event and Advisory Meeting:
A)Plan and implement Japan local scientific advisory meeting named Japan Scientific Advisory Meeting (J-SAM) in collaboration with corporate R&D and company functions.
B)For matters relevant to Japan local (and Asia) clinical development and New Drug Application (JNDA), plan and implement locally organized advisory meeting in collaboration with corporate R&D and company functions.
C)In alignment with the corporate and local R&D strategies and objectives, plan and implement medical event by collaborating with internal and external stakeholder.
6.Medical Expertise (apply only to a licensed physician in Japan):
A)Medical Consultation and Assessment:
①Assess borderline cases to determine incorporation or deviation.
②Determine relationship between the investigational therapy and reported events.
③In case of observed dose limiting toxicity (DLT)and/or serious adverse event (SAE), lead and manage site visit for medical engagement and education/consultation, and review/submit report to the responsible internal committee.
B)Medical Review: Conduct a review of protocol, informed consent form (ICF), Investigator’s Brochure, press release and/or a report of SAE.
C)Medical Monitoring: Conduct adverse event (AE) check, baseline chest CT in lung trials.
D)Medical Education: Conduct medical, including but not limited to immune-related adverse event (irAE), education for health care providers in relation to oncology clinical development and other global and local R&D initiatives.
E)irAE Management: As a member of OSU MD Group, collaborate with all necessary functions to lead and manage external medical interactions with health care providers.
7.Operational Excellence:
A)Develop, update and maintain an internal control framework relevant to OSA responsibilities.
B)Develop, update and maintain business standards, including but not limited to written procedure, guidance, other supportive documents and tools relevant to OSA responsibilities in collaboration with corporate R&D and company functions.
C)Monitor and track progress against plan and analyze (e.g., through feedback, After Action Review) to adjust for re-planning as necessary.
D)In addition to individual contribution, embed team-based work environment to enhance organizational capability and capacity through demonstrating our company’s Leadership Behaviors.
勤務地
東京都
給与条件
※前職での給与とご経験を考慮
※非公開
【昇給】年1回
【賞与】年1回
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企業ロゴはログイン時に表示されます
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業務内容
『オンコロジーメディカルアフェアーズ、メディカルサイエンスリエゾン(MSL)』

メディカル・アフェアーズ活動計画(Country Medical Affairs Plan:CMAP) に基づき、下記活動を行う。

・製品や医学専門性知識を科学的戦略の基に、サイエンティフィック・リーダー/メディカル・リーダー(SL/ML, 通称KOL)のサイエンスパートナーとして信頼関係を構築する。
・メディカル・アフェアーズ、研究開発部門の関係者とデータジェネレーションに関する企画実行。 SL/MLを中心とした研究者主導型研究(Investigator Initiated Study)に関する相談に対し科学的アドバイスを行う。
・活動から得られた情報を社内ステークホルダーに共有し、製品価値を最大化する。

≪CMAP作成に向けた情報収集≫
・SL/MLへ最新情報の提供およびディスカッションを行い、意見や考え方の情報収集を行う。
・学会等への参加を通じ、最新の情報収集と分析を行う。

≪製品活動への参加≫
・製品チームに対し、戦略・ポジショニングなどに必要な情報を提供する。
・社内ステークホルダーへの学術的サポートを行う。
・緊急安全性情報の発信が必要な際、メディカルの観点から適切な情報提供を行う。

★ワークライフバランス重視の働き方が可能です!
≪裁量労働制度≫
働いた時間ではなく、パフォーマンスで評価する制度。社員個人が業務の時間配分や作業の進め方を考え、始業・終業時刻、勤務時間を自らの裁量で柔軟に決定することができます。
≪フレックスタイム制度≫
一定期間(1カ月以内)の勤務計画を決定後、その範囲内で始業・終業時刻を社員個人が決定して勤務することができます。
≪在宅勤務制度≫
原則的には週1回程度、自宅で仕事することが認められています。
勤務地
東京都
給与条件
【年収】500万円 ~ 1000万円
※前職での給与とご経験を考慮
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企業ロゴはログイン時に表示されます
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業務内容
・指定されたプロジェクトにおけるメディカル・モニタリングの実施(指定されたプロジェクト担当の臨床開発医師としての業務。主として臨床試験モニターのチームとともに、プロトコールに関する患者さんの適格性や有害事象の評価、モニターへの教育、治験依頼者や治験責任医師への折衝などを行う。
・安全性上の問題を含む、医学的・科学的な問題に関する文書のレビュー
・臨床開発医師として、プロポーザル関連会議に参加。
・Feasibility studyへの医学的助言
・学会等への参加による最新情報入手
・社内安全性委員会への参加
・グローバルのメディカルドクターとの意見交換
勤務地
東京都/大阪府/兵庫県
給与条件
【年収】1400万円 ~ 1800万円
※前職での給与とご経験を考慮
日本イーライリリー株式会社
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業務内容
■職務概要:
臨床薬理の専門家として、日本の臨床薬理戦略のみならず、グローバル臨床薬理戦略の立案に参画し、化合物ごとに適切な臨床開発を効果的に行い、患者様に届けること。

■職務内容:
<主な職責>
・臨床薬理戦略の立案
・臨床薬理試験の計画立案、プロトコール作成、試験実施の医学的面での監視、報告書作成
・臨床薬理試験における安全性、薬物動態・薬力学の評価
・薬事文書を含む臨床薬理関連の文書作成に関与
<その他>
・その他の臨床薬理に関連する業務

■このお仕事の魅力
  新薬開発に携わる事は、将来的に不特定多数の患者さんのQuality of Lifeに貢献できる点が最大の魅力です。特に弊社は他社の既存製品/治療では満足度が低かった分野にいち早く注力し、治療成果や満足度を向上させる製品(Best in class, First in class)の開発・販売する事を開発戦略に掲げています。担当製品が上市され、多くの患者に治療成果が出た時、お金では買えない最大の喜びを感じる事ができます。

  グローバル環境下で、医学専門家として新薬開発のプロセスの中で主導権を発揮する事が出来ます。また海外のカウンターパートやから知的な刺激を受ける機会も多く、個人としてもさらに成長できるという魅力があります。

  臨床薬理はニーズが高いにもかかわらず、専門家が少ない分野ですので、活躍の機会が多いです。また、臨床薬理の知識は他の臨床試験をデザインするのにも役立つので、将来的に幅広い分野で役に立つ技能が身につきます。

■Career opportunity in the near future
 ・領域別 臨床開発医師
 ・セーフティーフィジシャン
 ・臨床薬理 医学部長
 ・グローバル臨床薬理医師
 ・グローバル臨床開発医師
勤務地
東京都/兵庫県
給与条件
【年収】1000万円 ~ 2000万円
※前職での給与とご経験を考慮
【昇給】年1回
【賞与】年3回
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企業ロゴはログイン時に表示されます
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業務内容
『オンコロジー領域統括部 - Medical Lead』

【概要】
 Represent Medical Strategy function of the assigned product and maximize the product value and patient benefit through Medical Plan development and implementation..

【役割】
UMN:
* Continuously Identify Unmet Medical Needs (UMN) related to assigned therapeutic area and interpret them into product level.
* Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.
* Direct interaction with external stakeholders and medical science liaisons to refine and adjust unmet medical needs to external environment

Data Generation:
* Identify data gap for the assigned disease area and adjust generation plans/activities at product level for the best coordination as a therapeutic area.
* Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.
* Ensure data generation plan is prioritized to generate data in a timely manner and aligned with business objectives
Publication:
* Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.
TL engagement:
* Support identifying TLs according to objective and transparent definition. Maintain and update the TL list at least annually.
* Track interactions and maintain relationship with TLs in a completely compliant manner with related procedural documents (PD).
* Peer-to-per discussion about BMS products based on the individual needs of the TL/HCP: - Scientific information; - Treatment option; -Clinical research
* Collecting, storing, processing and distributing medical insights for strategic BMKK areas: - Local treatment practice; - Ongoing clinical trials (competitor); - Competitor products perception; - UMN
* Answer unsolicited request (on & off label)
* Deliver medical presentation to TL (one-one & group presentation)
Identify TL / Speaker / investigator / Advisor
* Help speaker in slide/lecture preparation
* Approved interactions with MKT, Commercial, RMS and MR
* Help investigator to understand ISR submission

Medical Plan Management
* Keep consistency and maximize synergy among each Medical Plan in the assigned therapeutic area (if applicable) upon Medical Plan development phase (typically June ~ August). Update the Medical Plan at budget update cycle.
* Effectively and efficiently explain the Medical Plan and get endorsement from Executive Management in BMSKK as well as Global Medical.
* Completely understand internal PDs, other rules, and laws and regulations in Japan. Assure that Medical plans and its implementation comply with these rules/regulations/laws.
* Lead medical matrix team (consists of functions in JMAP) and align each activity with the Brand Team activity. Co-lead the brand team with Senior Product Manager. Participate in J-EDT/J-FDT from medical and scientific viewpoint.
勤務地
東京都
給与条件
【年収】800万円 ~ 1300万円
※前職での給与とご経験を考慮
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企業ロゴはログイン時に表示されます
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業務内容
【概要】
 Supervise directly reporting Medical Strategy Leads for Oncology 2 Team, keep consistency and maximize synergy among each medical activity within the assigned therapeutic area, and Play a role of Medical Strategy Lead if applicable.

【役割】
Individual and Matrix Leadership
-Supervise directly reporting Medical Strategy Leads including performance maximization and talent development (e.g. regular meeting/coaching), skill/knowledge training (e.g. assign trainings), target setting and performance evaluation (through Performance Connections).
-Matrix leadership of Medical Strategy Leads for more than one tumor types (e.g. Hematology or Upper GI) including responsibility for strategy i
- Responsible for performance maximization and talent development (e.g. regular meeting/coaching), skill/knowledge training (e.g. assign trainings), and negotiation and ensure that knowledge is transferred horizontally and vertically within the medical team (e.g. other medical leads, MSLs)
-Responsible for external collaboration coordination for budget, strategy, organization, and management

UMN:
-Continuously Identify Unmet Medical Needs (UMN) related to assigned therapeutic area and interpret them into product level.
-Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.
-Direct interaction with external stakeholders and medical science liaisons to refine and adjust unmet medical needs to external environment

Data Generation:
-Identify data gap for the assigned disease area and adjust generation plans/activities at product level for the best coordination as a therapeutic area.
-Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.
-Ensure data generation plan is prioritized to generate data in a timely manner and aligned with business objectives

Publication:
-Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.

TL engagement:
-Support identifying TLs according to objective and transparent definition. Maintain and update the TL list at least annually.
-Track interactions and maintain relationship with TLs in a completely compliant manner with related procedural documents (PD).
-Peer-to-per discussion about BMS products based on the individual needs of the TL/HCP: - Scientific information; - Treatment option; -Clinical research
-Collecting, storing, processing and distributing medical insights for strategic BMKK areas: - Local treatment practice; - Ongoing clinical trials (competitor); - Competitor products perception; - UMN
-Answer unsolicited request (on & off label)
Deliver medical presentation to TL (one-one & group presentation)
-Identify TL / Speaker / investigator / Advisor
-Help speaker in slide/lecture preparation
-Approved interactions with MKT, Commercial, RMS and MR
-Help investigator to understand ISR submission

Medical Education
-Keep consistency and maximize synergy among each Medical Education activity in the assigned therapeutic area (if applicable)
-Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.

Medical Plan Management
-Keep consistency and maximize synergy among each Medical Plan in the assigned therapeutic area (if applicable) upon Medical Plan development phase (typically June ~ August).
-Play a role of Medical Strategy Lead or assist Medical Strategy Lead as a supervisor, whichever applicable.
勤務地
東京都
給与条件
【年収】800万円 ~ 1500万円
※前職での給与とご経験を考慮

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[PR]
  • 医療業界で働く人のクチコミ情報サイト @Medicalist(@メディカリスト)

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