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CMC開発部門マネジメント
Carry out commercial excellence activities especially analysis of sales data and sales forecasting.
Oversee local implementation of Commercial strategies. Drive improvements and ensure business optimisation.
Lead in quality systems and practices to improve company's suppliers. Lead in supplier audit, issue handling, and continous improvement activities.
このポジションは、割り当てられた臨床研究をグローバルおよびローカルで管理し、スタディアクティビティ、予算、タイムライン、およびベンダーとの関係を監督する役割を担います。
- Receipt of information on adverse events, entry in database- Creation of case description (Japanese, English)- Primary evaluation of the necessity of reporting a defect to PMDA- Creation of adverse drug report- QC check
- CSS (Company-led research)- IIS (Doctor-led research)- Collaborative study- Including oversight of external CRO
Leading all clinical operations in cooperation with a CRO. Support the development of clinical protocols.
Lead in GQP QA activities for new products for the business. Communicate and manage CMOs in Japan to ensure effective overall quality.
Carry out research and identify new clients. Manage current client relationships effectively.
Lead in GQP QA activities for business. Lead a small team.
Develop and execute market access strategy. Lead tactical pricing & reimbursement, translate evidence to support local HTA submissions, and engage with stakeholders.
Drive market access strategy projects. Plan and execute market access strategies to ensure best patient access.
Drive health care policy shaping. Build relationship with key stakeholders both government and patient advocacy group.
Take lead in GCP QA activities for the business to ensure effective compliance. Reporting to the Head of Development Operations in Japan ensuring all risks and quality issues are resolved from a quality point of view.
Take lead in quality operations responsibilities for the warehouse. Lead in storage, delivery, packaging processes of pharmaceutical products for company's clients
✅ Lead Japan clinical and post-market safety planning and execution in a growing global biotech
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