臨床開発本部は日本国内外の臨床試験を通じて新しい医療機器の有効性と安全性を評価検証し、厚生労働省へ承認申請を行い医療機器として製造販売承認を取得する業務を担います。 · 解析計画の方針決定とその計画に沿った解析の実施 · ...

+Clinical Research Specialist · 治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成 · ,担当施設における手続き業務、モニタリングならびに監査対応 · ,関連文書の作成および確認 · ,内部・外部関係者との良好な関係構築 · ,, · ...

Clinical Science Lead also known as Sr Clinical Scientist responsible for leading regional country level Development Team in matrix setting ensure alignment across key stakeholders promote team work drive development Clinical Development Plan CDP relevant study designs team effor ...

The Japan Sr Project Lead serves as the project leader for development pipelines with comprehensive responsibilities including end-to-end development strategy alignment at both local and global levels. · ...

Clinical trial experience is required of MDs with over 3-5 years of corporate experience and development experience who hold Japanese medical licenses. · ...

The GCDSE provides clinical and R&D expertise in their region/country. · Accountable for global protocol development · Ensures consistency across trials in terms of site selection approval process · Responsible for country/regional interactions with regulatory authorities · ...

The Clinical Project Manager is accountable for the delivery of patient-centric studies from protocol design through to study report and archiving. · Accountable for the leadership and delivery of all assigned sponsored clinical trials. · Responsible for operational updates, iss ...

Roles providing expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. · Acts as a field-based expert, building relationships with External Experts as trusted scientific partners. Exchanges credible ...

Leads the development team to ensure alignment across key stakeholders and promote teamwork. Drives the development of Clinical Development Plans (CDPs) and relevant study designs through team effort. · ...

The Clinical Trial Supply Manager will be responsible for managing the supply of Investigational Medicinal Products (IMP's) and other clinical trial material in Japan. This includes ensuring the best set-up, execution and closure of IMP supplies and distribution to optimize perfo ...

To keep up and improve the local supply processes in Japan including roles and responsibilities of involved local and global functions as well as the SOP system which should be in line with global SOPs and working instructions. · ...

We are seeking a Medical Writer to join our team. You will create high-quality regulatory-compliant clinical documents supporting product life cycle under supervision. · Create high-quality regulatory-compliant clinical documents supporting product life cycle under supervision. · ...

The Pricing Strategist will be responsible to achieve UCB's Pricing & Access objectives for the pipeline portfolio (with focus on BKZ, rare diseases, Briviact and Staccato in mid-term). · Central to the role will be maintaining a clear view on priority opportunities to focus on, ...

The Local Safety Officer will serve as a clinical and post-marketing medical safety expert in Japan. They will be responsible for all signal management activities in the country and ensure that local product labels and risk management plans are properly aligned with the benefit r ...

The Medical Science Liaison (MSL) role involves exhibiting scientific and clinical knowledge to facilitate timely and appropriate exchanges with influential external experts. · Exhibits strong knowledge of relevant diseases, healthcare environment, competitors; can articulate med ...

The Cell Therapy Scheduling and Logistics Specialist I will be responsible for scheduling and monitoring patient treatment schedules for the manufacturing of Celgene's autologous cellular immunotherapy products. · Responsibilities include:Coordinate with cell collection centers t ...

The Senior Marketing Manager will be responsible for leading a team of marketing professionals accountable for creating and operationalizing go-to-market strategies for existing and new market segments by incorporating customer needs, competitive dynamics, portfolio positioning, ...

The Medical Manager will be responsible for planning and executing medical activities and ensuring timely and effective execution aligned to medical strategy. · ...

Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams. · Creation, update and maintenance of the Japanese package inserts in line with the CCDS, ...