Company: Novartis Farmacéutica
The Associate Director, Labor Rights EMEA will report to the Director, Labor Rights and is responsible for independently leading the identification, assessment, management, and mitigation of labor rights risks with Novartis external partners across the Europe, Middle East and Africa (EMEA) region. This is an essential role to fully operationalize Novartis refreshed labor rights strategy [...]Read More... from Associate Director, Labor Rights EMEA See details
-Monitors patient data & study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where [...]Read More... from SSU CRA – maternity leave See details
Direct, oversee and coordinate all activities, deliverables and resources within his/her respective group. Ensure that KPI’s are met and work closely with Operations heads for resourcing, metrics and budgeting. Work seamlessly with partner groups. Lead, contribute to and implement initiatives to establish and maintain statistical programming as best in class in the industry. About the [...]Read More... from Director Statistical Programming See details
-Understands complex and critical business problems from a variety of stakeholders and business functions, formulates integrated analytical approaches to mine data sources, employs statistical methods and machine learning algorithms to contribute to solving unmet medical needs, discover actionable insights, and automate processes for reducing effort and time for repeated use. To manage the definition, implementation, [...]Read More... from Associate Director Data Science See details
Location: Field based Territory: South Wales, Cardiff, Bristol, Plymouth, Exeter The MSL is a field-based, non-promotional Medical Affairs role responsible for scientifically engaging, collaborating, and aligning with a broad range of external stakeholders to identify and address patient and healthcare system needs in order to evolve clinical practice for better patient access and outcomes. They [...]Read More... from Medical Science Liaison See details
Location: Field based Territory: South Wales, Cardiff, Bristol, Plymouth, Exeter The MSL is a field-based, non-promotional Medical Affairs role responsible for scientifically engaging, collaborating, and aligning with a broad range of external stakeholders to identify and address patient and healthcare system needs in order to evolve clinical practice for better patient access and outcomes. They [...]Read More... from Medical Science Liaison See details
The Clinical Operations Program Manager (COPM) is responsible for providing operational support for clinical development programs and trials. Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies [...]Read More... from Clinical Operations Manager See details
Global Medical Affairs Director Immunology (Dermatology & Allergy) Job ID REQ-10036019 Jan 23, 2025 Spain Summary The Global Medical Affairs Director leads the medical strategy & tactics for a program/indication, ensuring the US and International medical perspectives are reflected. You will develop and execute the Integrated Evidence Plan (IEP) ensuring the right evidence is available [...]Read More... from Global Medical Affairs Director Immunology (Dermatology & Allergy) See details
Senior Global Program Regulatory Manager Job ID: REQ-10011576 Date: Jan 20, 2025 Location: United Kingdom Summary About the Role Major Accountabilities: ~ 负责实施监管策略，并管理指定主要/大型区域的运营活动。 ~ 为全球监管战略提供输入，并为监管职能计划（RFP）和种子文件或其等效文件贡献内容，包括识别指定区域全球战略计划中的差距或风险。 ~ 与各区域合作，统一监管策略，以实现业务目标。 ~ 跨指定区域实施监管职能计划。 ~ 确定卫生局（HA）与DRA GPT代表和/或GTAL互动的要求并设立目标。 ~ 促进简报簿的编制和定稿，并协助编制摘要文件。 ~ 制定并实施计划，以便及时响应卫生局的请求并协调响应。 ~ 可视乎地点(例如:美国食品药品监督管理局（FDA）或欧洲药品管理局（EMA）)，充当当地卫生局的联络人。 ~ 推动全球指定区域的协调、规划和档案提交。 ~ 审查全球档案摘要文件。 ~ 制定并实施计划，以避免/尽量减少出现提交审查停摆。 ~ 审查、批准并提交临床试验申请（CTAs）和试验性新药（INDs）。 ~ 审查并提交风险管理计划。 ~ 可独立领导或与DRA GPT代表和/或GTAL共同领导关于区域批准的谈判。 ~ 负责推动在DRA GPT代表和/或GTAL的指导下，及时向卫生局提交和批准档案。 ~ [...]Read More... from Senior Global Program Regulatory Manager See details
Location: Field based Territory: South Wales, Cardiff, Bristol, Plymouth, Exeter The MSL is a field-based, non-promotional Medical Affairs role responsible for scientifically engaging, collaborating, and aligning with a broad range of external stakeholders to identify and address patient and healthcare system needs in order to evolve clinical practice for better patient access and outcomes. They [...]Read More... from Medical Science Liaison See details
