新規ビジネスに関連する薬事承認を速やかに取得するための情報の入手及び早期の申請及び適切なタイミングで届出を行う。薬事規制を遵守するため、チームで合意された内容に則り、適切な対応を行う。 · ...

The Regulatory Affairs Specialist will be responsible for developing product-specific regulatory strategies, · handling medical device regulatory affairs including filing, certification and approval, · negotiating with authorities or certification bodies, · collaborating with rel ...

Töötaja peab olema võimeline saavutama ja säilitama tootevõimaluste ning vajadustega sobiva hinnangute strateegia.Peamisteks ülesanneteks kuuluvad: · ...

The medical device regulatory affairs specialist role involves ensuring compliance with regulatory requirements for medical devices. The position entails creating and submitting application materials to relevant authorities, · advising on PMDA matters including face-to-face consu ...

· メディカルエデュケーション&コミュニケーション部スタッフ · FAQの作成 · ローカルレスポンスドキュメント(LRD)の作成 · コールセンターの運営 · 2次エスカレーション対応 · グローバル質問対応管理サイト(One GMIの管理) · . FAQシステムの構築(外部サイト、社内Webページなど). 外部ベンダー管理 Li. ...

The Regulatory process management Lead is responsible with a focus on development and high quality submission planning and delivery as well as strong process and technical expertise. · Serve as Source Submission (Veeva Valt regulatory document tool) Expert within Regulatory Affai ...

The Lead Program Manager will develop and implement strategic plans and activities to foster positive awareness of the company with outside audiences. They will ensure all plans nest within corporate goals and sustain a favorable business environment. · ...

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 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 · ...

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, ...

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 ...

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

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 ...

The Deputy Country Quality Head will lead the implementation and maintenance of GxP quality systems in Japan. The role requires strong leadership skills and experience in quality system management, with a focus on compliance with health-regulated regulations. Key responsibilities ...

The primary purpose of a Project Manager (PM) is to ensure and elevate the level of country operations to realize patient value by transforming company's strategy into project delivery in Japan. · ...

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 Safety Specialist collaborates with teams to ensure safety communication and product stewardship. · ...

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, ...

This position will drive improvement initiatives locally to ensure that processes are capable of meeting the quality standards and expectations of the company and its customers.To provide technical support to QA and other departments. · To identify, design and lead/execute QE pro ...

At Research Solutions business at Life Science, we support researchers in academia, pharmaceutical, materials, analysis and various other industries who tackle the world's toughest problems through innovative approaches. · ...

Supports identification and collection of competitive technical product information and provides market-specific claims merchandising information demos and practices for current generation benchmark products.