Tokyo,14.0M ～ 18.0M

You will be responsible for:

Development and implementation of medical strategy and tactics in alignment with cross-functional partners and global counterpart

Responsible in the launch preparation of on-going late stage project in collaboration with global medical affairs.

Strong leadership and contribution in the cross-functional launch team in independent manner is strongly expected

In collaboration with MSL manager, develop and maintain medical KOL lists and communication plan, which aligned with medical and cross-functional brand plan

Planning and implementation of MA events such as advisory board, medical educations,i.e.Stand-alone medical symposium, webinars, congress medical events and presentation, video and other medical activities

Planning and promotion of Company Sponsored Research (CSR) and Externally Sponsored Research (ESR), particularly Externally Sponsored Collaboration (ESC) to address unmet needs and barrier in standard of care in collaboration with Evidence Generation lead and HEOR. Utilizing PMS and other data source creatively to maximize evidence generation is highly expected.

In collaboration with Publication lead, drive high quality publications of aforementioned evidence generations, encore presentations, case reports.

Planning and implementing Patient Support Program (PSP) and Patient Medical Programs in collaboration with Patient Program, Patient Advocacy and other functions. Seek future opportunities to develop data from such PSP.

Working with MSL managers to collect unmet medical needs and potential needs through interviews with health professionals, preparing reports, and sharing them with related departments to further improve medical plan.

Providing education and lecture slide review with the aim of carrying out appropriate company activities and message

Develop publication plan in collaboration with Publication lead, Evidence Generation Lead, HEOR, R&D,PMS and drive execution.

Support Medical Communication (Medical Information) to develop FAQ and answers to unsolicited medical requests

Tokyo,7.0M ～ 10.0M

＜品質保証活動の実行と改善＞
?品質保証責任者の方針に基づき、日々の品質保証業務を遂行
?製品・サービスの品質リスクに品質目標・KPIのモニタリングとデータ報告、必要に応じた対策の立案と実行

＜監査準備と対応＞
?内部監査・外部監査（GxP、ISO、顧客監査等）に向けた準備・資料整備・実行支援
?監査後の指摘事項に対するCAPA（是正・予防措置）を現場レベルで実行・フォローアップ
?部下と連携して、日常的な品質順守状況のチェックや現場巡回を実施

＜文書管理とSOP運用＞
?SOPや品質記録文書の作成・改訂・承認フローの管理、文書管理システムの運用
?現場でのSOP順守状況の確認と、改善指導の実施
?記録文書（バッチ記録・逸脱報告等）のレビューと整合性の確認

＜品質インシデント対応＞
?苦情・逸脱・不適合が発生した場合の初動対応と事実確認、部下への指示
?原因調査の推進、是正措置・再発防止策の提案および実行
?インシデントデータの傾向分析と改善活動へのフィードバック

＜顧客対応・社内外調整＞
?顧客からの品質関連問合せに対する初期対応および資料作成
?サプライヤー・製造委託先等との品質に関するやりとり（監査準備・品質協定の履行状況確認など）
?社内他部署（製造、開発、CS等）と連携し、品質向上活動を推進

＜メンバーマネジメントと育成＞
?チームメンバーの業務指導、OJT、育成計画の実施
?品質文化の浸透を目的とした教育・啓発活動への協力

Tokyo,10.0M ～ 12.0M

Job Details: Quality systems, business license management, conformity certification, and foreign manufacturer registration management.

-Maintain and improve the effectiveness of the Quality Management System (QMS), promote a culture of quality and continuous improvement across the organization through business license management, audit response, and document control.

-Build and maintain trust with regulatory authorities and internal/external stakeholders to support the foundation for delivering safe and high-quality products to patients and customers.


Role & Responsibilities:
Primary Responsibilities:
1. Business License Management & Regulatory Compliance
・ Maintain licenses for medical devices and related products.
・ Submit QMS conformity investigation applications and maintain conformity certificates.
・ Obtain and renew Foreign Manufacturer Registration (FMR).
・ Lead external audit responses (coordination with auditors, overall audit management).

2. Quality Management System (QMS) Maintenance
・ Support the development of quality policies, objectives, and manuals.
・ Plan, execute, and support QMS initiatives.
・ Conduct and record management reviews.
・ Evaluate and respond to legal revisions.
・ Provide regular reports and statements to senior management.
・ Lead nonconformance management (NCEP, CAPA, QN, PIRe, PIR).
・ Maintain training and internal audit processes.
・ Maintain procedures for validation of QMS-related software.

3. Document & Record Management
・ Maintain procedures for quality documents and records; operate document management systems.
・ Review documents and collaborate with relevant departments (e.g., lead IRR, participate in CoP).