過去の求人

GTM Strategy and Capability Development Manager

• JPY 9,000,000 - 12,000,000（JPY9,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top European Pharmaceutical Company Job Description 1. Develop mid/long-term actions to drive transformation of company and associated projects to success; - Monitor evolution of the pharmaceutical market in Japan and changes happening in government policy, regulatory and competitive landscape - Together with Head of Strategy and planning, develop possible go to market strategic options to achieve sustainable growth of company - Organize and manage a portfolio of initiatives to execute the identified strategies with consensus across Sr. Management team - Act as meeting coordinator and secretariat of key management meetings and drive follow up and action planning in coordination with leadership team - Establish solid collaboration across various division and department heads and be recognized as a value added team play 2. Lead capability development efforts across the organization and align key functions to defined training curriculum with monitoring and tracking; - Manage the overall training grid across key functions within the company with training curriculum defined and agreed with local functional leaders - Act as the representative of Japan on global training and capability building forums and bring best in class training content and delivery into Japan - Demonstrate strong passion for employee development along with expertise in understanding of instructional design and coordinating training delivery with external vendors 3. Drive change management and communication topics across company team demonstrating progress of transformation. - Coordinate execution of projects that drive measurement of voice of customer, voice of employee etc across the company - Coordinate sharing of best practices within the company and with corporate stakeholders showing achievement vs targets - Build strong collaboration within Strategy and team and drive cross-functional collaboration across key functions within the company Requirements - Track record in successfully leading cross-functional projects, involving multiple stakeholders into successful outcomes, hands-on approach and independent thinker (consulting background preferable) - Logical and strategic thinking, analytical skills with ability to bring project management tools into play for problem solving - Excellent communication skills – easy to connect with stakeholders across Japan and globally as well as across various levels within the organization; able to build effective partnerships with multiple stakeholders at all levels across functions - Exemplary presentation skills and ability to engage senior management in both English and Japanese - Strong domain understanding of customer centric processes, digital channels and platforms with ability to connect with commercial and IT stakeholders - Experience in driving training and capability building projects in large, complex organizations and leading change management initiatives · Consulting firm experience (3-5 years) · MBA preferable · Experience in leading complex cross-functional projects and in working with senior management · Experience in managing corporate learning programs desirable · Pharmaceutical experience desirable Additional Job Information If interested, please contact RGF Hr consultant Madina Aitzhanova at: T: +81-3-4400-2621 (D) +8180 4080 4777 madina.aitzhanova@rgf-professional.com

SCM Leader to Manager

• JPY 6,000,000 - 12,000,000（JPY6,000,000 - 12,000,000)
• 日本 東京
• 小売業界（高級商材/ファッション/アパレル/生活用品/家電　他）

Company Overview 日系グローバルアパレルメーカー。 ベンチャーマインド溢れながらも、連結売上500億円、国内340店舗超を有する上場企業。 若い方々が精力的に活躍されている企業です。 サプライチェーン事業部は、自身が当事者意識を持てば変化することができる、また建設的な意見交換の場が大いにある環境の中 変化やスピードを持って、新たなビジネスの根幹を築くことができます。 ご経験やスキルにより、配属先を決定し、将来的には領域を越え、サプライチェーン事業全体の幅広い領域を経験することができます。 Job Description ・国内外主要取引先の品質・価格・納期管理 ・国内・海外工場国内外の取引先、材料メーカーと協力した新商品開発 ・国内外主要取引先とのメガネ（レンズ・フレーム）の生産管理業務のマネジメント ・MD・デザイナーと製造委託先工場の間に立ち、サンプル製作から 正式オーダー、国内物流センター納品までの調整・管理（コスト・納期管理） 　 ・協力工場と新規性のある仕様や新素材開発のサポート ・既存工場(主に中国)との価格・納期交渉（出張月１～２回） ・海外新規取引先工場の開拓および育成 Requirements 【必須条件】 （ご経験） 以下いずれかのご経験 ・消費財メーカーにおける調達・生産・品質管理の実務経験（3年以上） ・SPA業界における調達・生産・品質管理の実務経験（3年以上）　 ・アパレル、アパレルＯＥＭメーカーの繊維商社においてMD経験　（3年以上） ・アパレル、アパレルＯＥＭメーカーの繊維商社において調達・生産管理の実務経験（2年以上） ・アパレル、アパレルＯＥＭメーカーの繊維商社においてMD経験　（3年以上） （知識・スキル） ・中国語、もしくは英語（ビジネスレベル）（志向性） 【歓迎条件】 ・原価管理 ・定量・定性情報をもとにした商談・交渉経験 ・社内・外の関係者を巻き込み、プロジェクトを完遂した経験　 ・商品企画やプロジェクトにおける進行管理・実務経験 ・工程・品質改善に関する実務経験 　 ・メーカーでのサプライチェーン構築の経験者 ・ISO9001、ISO13485にかかわる業務 ・薬機法に基づく製品の取り扱い経験 ・4年制理系学部または大学院卒 Additional Job Information If interested, please contact RGF Hr consultant Sachiko Nakagawa at: D: +81-3-6422-4424 sachiko.nakagawa@rgf-professional.com

営業（引っ越し）

• USD 1,800 - 2,000（JPY288,000 - 320,000)
• ベトナム ホーチミン
• メーカー(自動車/化学/家電/鉱物/工場　他)

Requirements ■業務内容 ・新規取引企業の開拓および既存顧客のフォロー ・お客様の引っ越し内容の確認や内見など、引越しに関する様々な手配 ■必須スキル ・引っ越し業界での就業経験 ・日常程度の英会話

Digital Marketing B2B

• JPY 6,000,000 - 7,000,000（JPY6,000,000 - 7,000,000)
• 日本 東京
• メーカー(自動車/化学/家電/鉱物/工場　他)

Company Overview Well-known High-technology Company that develops and manufactures many products Job Description - Creating websites and online product catalogue; - Search engine optimization; - Data mining; - In the future they plan to do e-commerce as well - Doing market research, business development through social media (twitter, Facebook, LinkedIn, etc.) - Report directly to the Global Head of Performance Solution Division (PSD) - Plan and execute all digital marketing campaigns, including web, SEO/SEM, marketing database, email, social media and display advertising - Utilize strong analytical ability to evaluate end-to-end customer experience across multiple channels and customer touch points - Keep close communication with Global Digital Marketing team (United State, United Kingdom,

Sales Manager

• JPY 7,000,000 - 8,000,000（JPY7,000,000 - 8,000,000)
• その他 すべて
• メーカー(自動車/化学/家電/鉱物/工場　他)

Company Overview Well Known Company that Manufactures and Markets Various Printing-Related Equipment and Materials Job Description  会社設立（各国で）  販売活動を行う  年間販売計画の作成と達成  ターゲットカスタマーとの関係構築  製品の技術的知識の習得  同部門（営業、サービス）並びに日本本社と連携をとること  関係製品の市場調査、競合調査、分析  新規開拓 Requirements 希望人材  各国の国籍である方  日系企業勤務経歴のある方  直販営業経験（法人営業、）  チームプレイを行うタイプ  コミュニケーション能力、調整力、問題解決能力、突破力といった資質を備えてい る方  本社に報告等の為、日本語でのコミュニケーションが必要となります。 Additional Job Information If interested, please contact RGF Hr Consultant Adinata Jahja at: T: 03-6422-4458 E: adinata.jahja@rgf-professional.com

Sales Engineer

• JPY 5,000,000 - 7,000,000（JPY5,000,000 - 7,000,000)
• 日本 東京
• メーカー(自動車/化学/家電/鉱物/工場　他)

Company Overview Well-Known International Company that is in the Measuring and Controlling Devices, nec Business Job Description • Will be belonged to the testing machine division and report directly to the sales manager. Doing business development for testing equipment and machines produced at the Germany factory to automotive industry companies. Our strategy is focused for Customer satisfaction. • Creation and achievement of annual sales plan (including quarterly forecast) • Build relationships with target customers • Learning technical knowledge of products and applications • Build teamwork with the same department (sales, service) and German factory • Market research, competitive research, analysis of related products Requirements • Direct sales experience (large machinery such as equipment machine sales etc. is desirable) • Product technology, application understanding • Able to work in a team • Person who possesses qualities such as communication skill, coordination ability, problem solving ability, and breakthrough ability • Communication in English with German and Asian countries is required. • Willing to do long-term business trips (1 week -) Additional Job Information If interested, please contact RGF Hr Consultant Adinata Jahja at: T: 03-6422-4458 E: adinata.jahja@rgf-professional.com

Sales

• JPY 4,500,000 - 5,500,000（JPY4,500,000 - 5,500,000)
• 日本 東京
• メーカー(自動車/化学/家電/鉱物/工場　他)

Company Overview International Company that operates in the Industrial Equipment Wholesalers industry Job Description 職務内容： ・食品プラントの提案、見積、販売 ・食品機器の見積、販売 ・既存顧客への営業活動 ・新規顧客開拓 ・代理店管理 ・マーケティングと PR(展示会への出展等) ・セールスレポート作成 Requirements 資格・条件： ・英語 初級(英語に興味がある、英語に抵抗がない) ・営業またはエンジニア経験 ※食品プラント業界であれば尚良し ・機械商社の方でも可 ・機械、海外に興味がある方 ・好奇心旺盛で、チャレンジ精神のある方 Additional Job Information If interested, please contact RGF Hr Consultant Adinata Jahja at: T: 03-6422-4458 E: adinata.jahja@rgf-professional.com

Sales Manager

• JPY 9,000,000 - 10,000,000（JPY9,000,000 - 10,000,000)
• 日本 東京
• 多角事業経営企業

Company Overview World's Largest Manufacturer of Metal-Cutting Tools Job Description - Meeting or Exceeding Annual Plan Numbers - Delivering monthly, quarterly, and annual plans and forecasts - Optimizing sales of existing customers - Developing sales of new customers - Designing and executing growth initiatives Requirements - Technical background - Common sense, critical thinking, and problem solving skills - Calm and assertive personality - Experience in cutting tools helpful - Native in spoken and written Japanese - Fluent in spoken and written English helpful Additional Job Information If interested, please contact RGF Hr Consultant Adinata Jahja at: T: 03-6422-4458 E: adinata.jahja@rgf-professional.com

Marketing

• JPY 3,500,000 - 7,500,000（JPY3,500,000 - 7,500,000)
• 日本 東京
• インターネット業界（IT/ソフトウェア/ハードウェア/モバイル/通信　他）

Company Overview モバイルアプリの課題発見から解決までをワンストップで提供するグロースハックツールを提供している企業 Job Description - マーケティングチームメンバーのマネジメント業務全般 - 国内初のアプリマーケティング特化イベントの開催 - 地方大都市でのマーケティング活動立ち上げ、パートナー開拓 - 他ツールベンダーとのマーケティング・営業戦略立案、実行 - 非IT業種向けのマーケティング・営業戦略立案、実行 - 代理店・開発会社向けのマーケティング・営業戦略実行 - 自社ツールを使いながら、アプリマーケティングのあるべき像を考えて時代を変えていく Requirements 必須要件 ￣￣￣￣ - マネジメント経験 - IT業界経験1年以上 - 最後までやりきる力、コミット力 - 自ら考えて行動に移せる人 - 40歳以下 歓迎要件 ￣￣￣￣ - B2Bマーケ/B2Bインサイドセールスの経験 - オウンドメディア運営の経験 - パートナーセールスの経験 - 営業企画の経験 Additional Job Information - 年収　350万～750万 - フレックス制（コアタイム13:00〜16:00）を採用しています。

Retail Director

• JPY 15,000,000 - 20,000,000（JPY15,000,000 - 20,000,000)
• 日本 東京
• 小売業界（高級商材/ファッション/アパレル/生活用品/家電　他）

Company Overview Leading European Company engaged in the Fashion Industry Job Description - Review daily sales of responsible company stores, in order to achieve sales target, comp sales and sales budget; - Supervise Retail Operation Manager to make sure the sales achievement; - Supervise Retail Operation Manager in terms of Customer Service (Customer Relations); - Supervise Retail Operation Manager, in order to negotiate with department store for new store openings and the better location; - Supervise Retail Merchandising Manager for the seasonal buying process and merchandising process; - Supervise Visual Display Manager to ensure the image at the store; - Hold periodical Store Managers’ Meeting to increase the communication effectiveness; - Develop sales strength of Store Managers and Staffs; - Recruitment and placement of the retail staffs working closely with HR Director. Work interdependently with HR Director for in-store HR issue; - Supervise Retail Operation Manager, in order to observe Store Managers and Staffs’ everyday operation and attitude in order to maintain company image; - Supervise Retail Operation Manager to implement the improvement plan in case of the improvement required for retail store employees. Inter-dependency with HR is necessary for making improvement plan as well as implementation. Requirements Essential skills: - Retail Operation at Luxury Fashion Industry - Merchandising at Luxury Fashion Industry - Visual Display at Luxury Fashion Industry - Leadership and Management Skill - Product Knowledge - Basic HR related skill - Communication Skill - Product Liability Management - English communication skill with Italian HQ Additional Job Information If Interested, please contact RGF Hr Senior Consultant Annie Siew at: D: +81-3-6422-4479 | M: +81-(0)70-1048-5422 annie.siew@rgf-professional.com

PR Manager

• JPY 8,000,000 - 10,000,000（JPY8,000,000 - 10,000,000)
• 日本 東京
• 小売業界（高級商材/ファッション/アパレル/生活用品/家電　他）

Company Overview Famous American Luxury Jewelry and Specialty Retailer Job Description

Supervise planning, execution, and management of public relations activities. Provide suggestions and instructions for direction of public relations activities. Ensure that company's business strategy is reflected in planning of public relations activities. Responsible for managing development of plans and ensuring effective, efficient operation. - Formulation of public relations programs: Formulate public relations programs, consistent with company's business/merchandise strategies. (25 %) - Management of public relations activities: Execute activities and monitor the progression. Modify direction of activities. (25 %) - Management of PR events: Formulate, instruct and supervise PR events; new product launches, store openings, etc. (25%) - Management of PR result and report: Monitor PR results monthly / on project and report to Director / NY Central PR. (10 %) - Coaching staff: Coach the subordinates to work efficiently (10%) - Budget management: Manage monthly / project budget. (5 %) Current PR manager will stay until end of August. Requirements  More than five years of relevant professional experience in public relations  Extensive knowledge of public relations, preferably digital PR including social media activations  Have a strong network with media and influencers including millennials  Good command of English  Excellent management and decision making skills  Excellent planning skills Additional Job Information If Interested, please contact RGF Hr Senior Consultant Annie Siew at: D: +81-3-6422-4479 | M: +81-(0)70-1048-5422 annie.siew@rgf-professional.com

語学力	英語レベル:ビジネス会話;日本語レベル:母国語と同様;

optics business manager

• JPY 9,000,000 - 11,000,000（JPY9,000,000 - 11,000,000)
• 日本 東京
• サービス業界（メディア/広告/コンサルタント/教育/外食/飲食/美容/娯楽/士業　他）

Company Overview One of the Largest Market Research Companies in the World Job Description 1. 小売店パネルデータ（メガネフレーム・メガネレンズ）をもとにした - 担当クライアントに対する定期的なレポーティング、データ分析、ニーズ把握、企画提案 - 新規クライアントに対する小売店パネルデータサービスの提案 - 既存クライアント対する契約更新提案 2. クライアントのニーズに沿ったソリューション提案、カスタムリサーチ提案、実査、レポーティング 3. グローバル本社との連携業務（外資系クライアントへの提案や、クライアントへの分析プレゼンテーション、ワークショッ プ） 4. マーケットレポートやプレスリリースの作成・発信 ＜入社後＞ 3 ヶ月～半年ほどの OJT で実際の案件に関わりながら業務を覚えていただきます。  パネルデータの読み込み、システム使用方法のトレーニング  クライアントや小売を訪問し、分析・レポーティング内容について説明  データ分析手法のトレーニング、実際のレポート作成 Requirements 1. B to B（クライアントや取引先企業）での折衝経験が 3 年以上あること 2. 様々なフィールドの人間とのコミュニケーション能力 3. データベースを利用した実務経験・または基本的な知識があり、強い興味を有すること 4. パワーポイントを使った対外的なプレゼンテーション能力（日英） 5. エクセルを使ったデータ処理（ピボットテーブルレポートなど）が出来ること 6. 物事をロジカルに考え、説明する力があること <あれば望ましいスキル・経験> 1. 統計、拡大推計データへの理解 2. 量的調査の経験、もしくは量的調査の手法への基本的理解 3. オプティクス業界経験、もしくはオプティクス業界や市場への興味 4. マーケティングの基礎知識もしくは興味・関心、マーケティング業務経験があれば尚可 5. ビジネスレベルの英語力（海外との業務経験又は TOEIC800 点以上） <求める人物像> 1. 好奇心と探究心を持って取り組む姿勢 2. 新しいことへのチャレンジに前向きで、主体的に考え、行動できること Additional Job Information If interested, please contact RGF Hr senior consultant Kana Hashimoto at: D: +81-3-6422-4416 | kana.hashimoto@rgf-professional.com

Foreign Legal Affairs

• JPY 4,300,000 - 6,100,000（JPY4,300,000 - 6,100,000)
• 日本 東京
• インターネット業界（IT/ソフトウェア/ハードウェア/モバイル/通信　他）

Company Overview Global Gaming Company Job Description -Foreign contract affairs -Overall management of overseas subsidiaries' contracts, disputes, etc. -Liaise with overseas subsidiaries' lawyers Requirements -2 years or more on English legal contract affairs experience -2 years or more on lEnglish contract reviewing experience -those who is interested in games Welcomed skills -English contract drafting skills -Experience working on foreign patent affairs

UX manager

• JPY 9,000,000 - 11,000,000（JPY9,000,000 - 11,000,000)
• 日本 東京
• サービス業界（メディア/広告/コンサルタント/教育/外食/飲食/美容/娯楽/士業　他）

Company Overview One of the Largest Market Research Companies in the World Job Description 1. 営業/アカウント担当 2. UX リサーチプロジェクトのマネジメント 3. ジュニアメンバーの育成 4. 海外 GfK グループ拠点との連携 Requirements 1. アカウント担当経験 2. ユーザーインタビューやユーザビリティテストの設計および実査経験（10 年以上） 3. インタビューのモデレーション経験 4. ビジネスコミュニケーション能⼒ 5. 英語⼒（海外との業務経験⼜は TOEIC800 点相当以上） Strictly confidential Page 2 of 2 あれば望ましいスキル・経験 1. チームマネジメント経験 2. ⼈間中⼼設計専⾨家/スペシャリストなどの資格もしくはバックグランド（⼈間⼯学や認知⼼理学など） 3. メーカーでの商品企画やマーケティング経験 Additional Job Information If interested, please contact RGF Hr senior consultant Kana Hashimoto at: D: +81-3-6422-4416 | kana.hashimoto@rgf-professional.com

ファイナンス　マネージャー

• JPY 7,000,000 - 9,000,000（JPY7,000,000 - 9,000,000)
• 日本 東京
• 小売業界（高級商材/ファッション/アパレル/生活用品/家電　他）

Company Overview - Our client is a global retail company with a strong, growing presence in the Japanese market. - Our client can offer the right candidate the chance to grow his/her career in a fast-paced environment, which can work as a stepping-stone for even more senior assignments in the future. Job Description - Coordinate with other business units in the region to consolidate the sales-related numbers to visualize the regional business performance - Support the monthly closing and forecasting, delivering all the necessary reporting in the timing manner with accuracy, while making sure the stories are clear to the senior management - Regular reporting including weekly/monthly/quarterly - Be the primal interface for other key back office functions to maintain the reporting efficiency - Coordinate the annual budgeting and long range planning processes / monthly re-forecasting process, partnering with key stakeholders to maximize development opportunities and mitigate risks - Conduct business trend analysis to feedback the business to drive the sales - Lead or be part of any special project as requested Requirements - A university degree or equivalent - 5+ year experience of finance related function, ideally in a multinational company, partnering with commercial functions and headquarters groups - Good understanding on accounting / finance knowledge - Analytical skills united to a strong commercial mindset and the ability to create sound partnerships with key stakeholders

Project Specialist II Clinical Oncology

• JPY 5,000,000 - 12,000,000（JPY5,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Description Join a game-changing company that is reinventing the way therapies are developed and commercialized. We bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. Position Summary: Supports Project Manager (PM) to ensure the contracted services and expectations of a clinical study are carried out by the assigned project team in accordance with the executed contract and the Customer’s expectations. Tracks and analyzes project details and maintains internal systems for assigned projects within a therapeutic area. Assures compliance with local regulations, Code of Federal Regulations/International Conference of Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and Company and Sponsor Standard Operating Procedures (SOPs). Mentors and coaches site activation staff in specialized areas of expertise (e.g., ICF/IB/IRB/Advertising review teams). Job Description Essential Job Functions: Project Administration - Utilizes designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, supplies, Institutional Review Board re-approvals, data queries) in order to provide analysis of information to PM. Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects. Supports assigned PM with initiating requests to Finance Department to generate customer invoices for project labor and expenses. Oversees regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. May conduct secondary review of Essential Regulatory Documents. May serve as project representative for internal and external TMF audits. May serve as in-house site contact for collection of non-essential regulatory documents, tracking and maintaining drug/study supplies, query resolution, administrative protocol and study related questions. Assists the PM with projection and validation of financial backlog and project realization on assigned projects. Includes review of regular financial reports and analysis of upcoming project events to verify financial forecasts. Assists in the development of Informed Consent Form using project specific knowledge and performs in-house Case Report Form review. Reporting - Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PM. Assesses and communicates KPIs for associated job tasks to PM with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PM. Communication - Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. Schedules and attends internal and external team meetings. May lead internal team meetings and portions of external team meetings as directed by assigned PM. Prepares and distributes all meetings minutes for both internal and external meetings. Follows-up with team members on action items from meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. Prepares for and attends Investigator Meetings, Kick-Off Meetings, Quick Start Camps, and Quality Finish Camps. Training- May train new employees assigned to project. Project Leadership - May serve as primary customer contact when PM is out of the office. Seeks input from Project Director for customer support. Requirements Qualifications BA/BS in the science/healthcare field, nursing degree, or equivalent combination of education and experience. Minimal clinical research experience. Some experience in a company therapeutic group preferred, with demonstrated leadership skills and effective customer interaction. Basic understanding and knowledge of ongoing protocol and disease related terminology, FDA regulations, GCP/ICH guidelines, drug development process for assigned study, as well as company and sponsor SOPs and WIs. Exceptional attention to detail, organizational, interpersonal, and communication skills with demonstration of critical thinking and problem solving skills. Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), web-based systems, email, and voicemail. Ability to perform several tasks simultaneously to meet deadlines. Self-motivation and ability to work independently. Ability to assist in establishing and maintaining standards, system integrity, and ensuring quality assurance measurements.

Clinical Team Leader-Oncology

• JPY 6,000,000 - 13,000,000（JPY6,000,000 - 13,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Description Join a game-changing company that is reinventing the way therapies are developed and commercialized. We bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. Job Description Summary: The Clinical Team Leader (CTL) serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study (ies). Responsible for the planning, conduct, and oversight of assigned Clinical Research Associate/Clinical Monitoring Associate (CRA/CMA) operational study team and site management study activities to ensure clinical study and site deliverables are met with quality and timeliness. May provide administrative line management, which includes oversight of training, compliance, performance and career management, and development of direct reports. Provides metrics to the project team to demonstrate current and planned status of the study. Essential Functions: Line management responsibilities for staff members: may participate and direct activities related to department staff operations such as interviewing and selection, training compliance, professional development, performance management, and employee counseling and separations. Approves courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods. Evaluates and reports direct report workload forecasts and trends to ensure proper resource allocation. Reviews CRA metrics and ensures targets are understood and met. Evaluates staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process. Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions. Responsible for team member clinical/site management study deliverables as the clinical functional team leader. Drives and manages the clinical and site management aspects of assigned study during all study Trusted Process phases. May be a standalone lead or part of a regional or global clinical functional lead team. Develops and maintains study clinical plans, guidelines and tools, including the Clinical Monitoring Plan (CMP). Manages compliance to the monitoring strategy agreed with the Sponsor and outlined within the budget and study contractual agreement, including any requirements of monitoring driven by Strategic Data Management (SDM). Reviews the study scope of work, budget and protocol content and ensures the clinical study team (CRAs/CMAs) is aware of the parameters. Escalates to the PM any clinical/site management deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope. Attends and presents monitoring/site management status during routine sponsor meetings (teleconferences and face to face). Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP, and risk plans. Provides development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables. Routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data Monitoring (SDM) and/or other dashboards to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality. Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. Supports site selection process, following company process for site ID and feasibility. Tracks and evaluates components required for site initiation scheduling and conduct, and prompts proactive planning. Is accountable to proactively plan and directly collaborate with other functional leads (SSU and site contracts) and the clinical team members to ensure timely site initiation, and site activation timeline maintenance at the regional or study level. Tracks and evaluates components required for effective and timely SDV and data flow, reviewing status of site and study eCRF entry, SDV, triggered monitoring conduct, query response, and data cleanliness. Proactively collaborates with data management functional lead to plan towards data cut and lock deadlines. Develops and executes corrective action plans at site and study level to address any issues. Collaborates with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and country regulations, including medical monitoring, Safety, QA. Assists with clinical listing reviews. Represents the clinical team and site management functional activities at Trusted Process and sponsor meetings. Attends and presents at Kick-off, Quick Start Meetings and Investigator Meetings. Prepares and presents Site management/Clinical monitoring materials for bid defense meetings. Reviews and oversees the protocol deviation trends identified by the clinical monitoring team. Ensures team follows process for documentation of protocol questions and deviations. Ensures ongoing essential document collection, TMF maintenance and quality of content for assigned areas. Other Responsibilities: Performs other work-related duties as assigned. Moderate travel may be required, 25% to 50% on a regular basis. Requirements Requirements: BA/BS degree in the science/health care field or nursing degree, or equivalent combined education and experience. Moderate independent field monitoring experience. Minimal lead monitoring or comparable supervisory experience. Extensive understanding of SOPs, Work Instructions (WI), FDA, and local regulations as well as ICH GCP guidelines, and an advanced understanding and application of applicable therapeutic standards. Ability to apply problem solving techniques to resolve complex issues at investigator sites and within study, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research study at an investigator site. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), e-mail, and voicemail. Effective command of written and spoken local language, if not English, as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials strongly preferred. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

神戸医薬研究所薬物動態安全性研究部非臨床安全性グループ　マネージャー職 Pathologist

• JPY 8,000,000 - 12,000,000（JPY8,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview ◆グローバルランキング20位以内 ◆医療用医薬品、アニマルヘルス、そしてバイオ医薬品受託製造の3つの事業分野に強み ◆循環器、呼吸器、中枢神経などの幅広い疾患領域での製品力 Job Description This position is responsible for non-clinical safety evaluations of multiple complex projects with toxicology/pathology knowledge in accordance to all applicable guidelines/regulations in close cooperation with partners and leading the interactions with Japanese regulatory agencies Duties & Responsibilities: • Safety assessment with high quality and within timeframe on products under development and on market 　・ Close communication with Germany and US 　・ Precise evaluation of toxicology data 　・ Play a role as an active R&D member of given projects • Preparation of pertinent safety documents for J-NDA submission with high quality 　・ Preparation of CTD for J-submission 　・ Communication with toxicologists /pathologists • Contribution to global non-clinical safety activity in preparation of TS in CTD 　・ Preparation of TS for global CTD 　・ Collaboration with toxicologists/pathologists 　・ Harmonization with standards 　・ Share the international workload • Establish a reliable network with authorities and academia 　・ Establish a list of experts in toxicology in Japan 　・ Exchange information • Align the functional activity worldwide 　・ Facilitate the international harmonization with NDSs in Biberach and Ridgefield • Evaluation of toxicology package 　・ Toxicological evaluation of all in vitro /in vivo toxicity studies • Pathology diagnostics and interpretation 　・ Evaluation of the pathology data from toxicity studies and carcinogenicity studies 　・ Monitor and evaluate modern technologies in the field of pathology 　・ Read slides and write a concise pathology report on non-GLP toxicity studies 　・ Responsible for the pathology software of the pathology data entry system Requirements ・獣医免許 ・日本毒性病理学会認定(JSTP)　 ・日本獣医病理学専門家協会(JCVP)　 ・Required Capabilities (Skills, Experiences, Competencies) 　・Exceptional level of knowledge in the field of responsibility(Toxicology/Pathology) 　・Negotiation skills in English / Japanese 　・Knowledge on regulatory related laws and guidelines in drug development 　・Strategic thinking 　・Board certificate in Toxicologic Pathology / Veterinary Pathology ・Language 　・Japanese: Native/Fluent 　・English:Native/Fluent ・Special Work Experience 　・>5 years experiences of working for international pharmaceutical R&D 　・Proven performance record of working in the field of responsibility (>3 drug development projects) 　・Good connection with academia and authorities