For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
We will use your ability to integrate/apply knowledge of global & Japanese regulations governing drug development to progressing Regenerons portfolio. This includes preclinical and clinical drug development programs, policies, and procedures. This is an exciting opportunity
This position involves applying a proven understanding of CMC elements and regulatory requirements to support, and provide guidance to Oncology/ Hematology teams in Japan. This position also supports all CMC regulatory filing activities including the preparation of
Be part of one of the leading biopharmaceutical companies in the industry. Take lead in RA development strategies as well as lead the RA team. Client Details * Be part of one of the top global
Be part of one of the top global biopharma business in the industry. Take lead in QA activities for the business to ensure effective compliance. Client Details * Be part of one of the top global
■ 職務内容 / Job Description Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in
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This is what you will do: The Marketing Director is a senior commercial leader responsible for strategic direction on asset portfolio within the assigned therapeutic area. S/he delivers on revenue and profitability goals by leading cross-functional
About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
Job Purpose MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to
Position Purpose: The Regulatory Strategy Group Manager is a key leadership position in Japan Regulatory Affairs (RA) who contributes to achieve organizational vision and goals aligning with the strategic objectives of Global Regulatory Affairs (GRA) and
責任: • 担当する製品（開発品及び既承認品を含む）に関連する日本におけるあらゆるCMC規制側面の評価を行う ・国内外のチームメンバーと協力しながら担当する品目のライフサイクルマネジメントのためのCMC戦略の策定及び実行を行う ・日本の薬事規制及び要求事項に従って、グローバルのCMC文書（CTD M3や報告書など）に基づき、CMCに係る薬事申請資料（承認申請書やCTD M2.3）を作成する ・グローバル戦略に従い、担当する製品に関する規制当局との相談を行う ・ GRA CMC、社内外の関係者、規制当局と、プロジェクト計画の目的、技術文書の編集、更新、CMC規制に関する質問への対応のための主要な窓口となる。 • いずれも必要に応じてCMCエキスパートなど上司の監督の下で遂行する 望ましい応募資格: 学位： ・ライフサイエンスの学士号 ・ライフサイエンスあるいは経営学の上級学位（博士号、医学博士号）、MBAがあればなお可 経験： • 製薬業界で、薬事又は品質保証における5年以上のCMCに関する経験 ・開発品又は既承認品に関して、J-NDA、PCA又はMCNなどCMC薬事に関する経験があればなお可 地域によっては、記述されているジョブプロファイルとは異なる資格や職責が求められる場合があります。使用している職務記述書をご参照ください。 Our Benefits We encourage you to make your well-being a priority. It’s important and
Position Purpose: Senior Regularory Strategy Expert is responsible for all regional regulatory strategic and operational tasks for a range of development products/projects in the assigned TAs in Japan. The Senior Regularory Strategy Expert also provides technical
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Position Purpose: To lead Quality Assurance group developing talents To operate appropriately quality events in compliance with global CSLB policies and local regulatory requirements To collaborate with internal partners, such as global Quality Assurance, global manufacturing
Build key partnerships with business leaders (GM Japan and the Japan Leadership Team/Japan Executive Committee) as well as being a liaison for CSL Japan based legal entities to enable the creation and implementation of an HR
Position Purpose Develop and implement the business strategy for the HEM product portfolio, with both short-term and long-term business objectives. Oversee and lead all marketing and sales plans to achieve the business objectives within policies and
Position Purpose: ・HZ/PGのブランドプラン・エリアセールスプランに則り、Highポテンシャルである脳神経内科・血液内科・小児科において、CIDP・SID・PIDに対する適正使用および症例獲得の最大化を目指す。 ・Ig BU Area Sales Managerと連携し、Ig BUのターゲット施設でのMRプランを策定し、実行する。 Reporting Relationships: Reporting to Ig BU Area Sales Manager Main Responsibilities and Accountabilities: ・Area Sales Plan作成にArea Teamのメンバーとして貢献する ・ブランドプランに則り、自身のエリアの深い分析を行い、MRプランを立案し戦術を実行する ・ブランドプラン、エリアプランに則り、ターゲットDrにCIDP、SID、PID（顧客・患者ごとに対して）の提案を実施する ・顧客エンゲージメントを高めるためにC360 Veevaを使用して顧客分析および戦略を策定する ・マルチチャネル(デジタルを含む)を顧客毎に効果的に活用し、情報提供を実施する ・コンプライアンスを遵守し、適正使用情報を推進する Position Qualifications and Experience
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
