エージェント取り扱い求人

Associate Director, Global Insurance and Risk Management

募集中
  • 勤務地
    東京都
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 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
雇用形態 正社員
応募資格 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
英語力 問わない
年収 500万 〜 1300万円
給与詳細
月額(基本給):310,000円~
<昇給有無>有
<残業手当>有
<給与補足>
※年収は前職の経験を考慮の上、規定により決定します。
■昇給:原則年1回
■賞与:年2回
勤務地 東京都
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

企業情報

匿名

関連する求人

エージェント取り扱い求人
Commissioning & Qualification Lead, Japan New Plasma Facility Project

ACCOUNTABILITIES Manage, identify, hire, and develop a team to support commissioning and qualification of a new Plasma Manufac-turing facility. Manage continued growth, development, and retention of the team. Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate. Responsible for planning, scheduling, and leading commissioning and qualification assignments. Must demon-strate competent and effective planning, coordination, and organizational skills. Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification ele-ments, as applicable, to develop the commissioning and qualification strategy based on concepts of risk-based CQ which includes user requirements, functional specifications, design specifications, commissioning and qualifica-tion. Emphasis is on ensuring commissioning and qualification activities meet defined timelines and budget while being in compliance with regulatory guidelines and industry standards. Guide peers in Commissioning and Qualification and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate. Ability to present a course of action to management and project team using both written and verbal communication tools. Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present commissioning and qualification strategy and protocols in regulatory inspections. Supervise commissioning and qualification personnel, contractors and outside vendors to meet project timelines, goals and milestones. Monitor and report commissioning and qualification costs including capital and cross-functional expenses. Perform other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have vast experience, proficiency and leadership in pharmaceutical/biotech commissioning and qualification of large capital projects. which includes the writing and executing of protocols and standard operating proce-dures. Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all commissioning and qualification elements. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team management. Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to meet timelines, budgets and desired outcomes. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

  • 600万〜1000万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Maintenance Technical Staff/ 保全技術担当者

【職務内容】 医療用医薬品やワクチン等の製造設備について以下の業務に従事いただきます。 ・作業指導書に則った製造設備の予防保全 ・保全受託業者への指示、管理・監督業務 ・報告書および記録書の照査 ・保全・修理作業の際に十分な安全対策を実施していることを保証する ・設備のトラブル時の修繕

  • 500万〜800万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Senior Validation SME Manager for Cleaning Validation, Engineering

【職務内容】 工場の新設工事ならびに改良工事における、洗浄バリデーション業務を実行します。 ・医薬品製造設備の洗浄プロセスを評価し、バリデートする責任を負います。 ・主な業務には、プロトコール作成、バリデーション作業の調整、バリデーションの実施、最終報告書の作成、最終バリデーションパッケージの作成、プロジェクト計画の作成が含まれます。 ・イニシャルバリデーションと再バリデーションの両方の責任を有します。さらに、製造上の課題の調査を行い、プロセスの改善を評価し、報告文書を作成します。 ・規制当局への文書提出、またはそれをサポートし、内部および外部の査察の際、必要に応じて利用できるように保管・管理します。 上記の業務を製造部門、エンジニアリング部門、薬事部門、品質管理部門、品質保証部門と日々連携して業務を行います。

  • 900万〜1300万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Specialist, Narita Quality Systems & Compliance (Annex 1 improvement/Validation)

職務内容 成田工場のバリデーションプログラムを改善し再構築するプロジェクト、或いは無菌医薬品製造に関連するPIC/S GMPガイドラインAnnex 1の対応プロジェクトの品質部門の専門家として、社内の仕組み改善に取り組んでいただきます。 具体的には、バリデーションプログラムの改善プロジェクトでは、工場内の専門家と協同し、工場のバリデーションマスタープランを改訂したり、バリデーションプログラム(SOP)の見直し及び改訂を行い、適切な頻度と内容で、あらゆるバリデーションが実施される仕組み作りに積極的に取り組んでいただける方を求めています。バリデーションは、製造、洗浄、滅菌、コンピュータ、分析法、機器など、あらゆる種類のバリデーションに対応する必要があります。またPIC/S GMPガイドラインAnnex 1の対応プロジェクトでは、無菌医薬品製造に関わるSOPの見直しや改訂を行っていただきます。 この職務を実行するために、GMPに関する知識や経験は当然のこと、無菌医薬品製造やバリデーションにかかわる知識やスキルも向上させていただけるやりがいのある職務です。 仕事のやりがい 工場の品質部門の担当者として、工場内の各専門家とバリデーションプログラムの改善及び再構築を進め、堅牢なバリデーションの仕組みを作り上げる。または、PIC/S GMP Annex 1適合のためにSOPなどの仕組みの改善を行う。 身につく経験・スキル バリデーションに関する知識、無菌医薬品製造に関する知識、プロジェクトマネジメント、コミュニケーションスキルや問題解決スキルの向上。血液分画製剤のQuality としての経験や知識の蓄積。 可能なキャリアパス 品質部門のグループマネジャーや部長

  • 500万〜800万
  • 千葉県
  • 医薬品メーカー(先発医薬品)

募集中