Junior analyst állások Németországban (egészségügy, gyógyszeripar)

• Become an expert in Brainlab's orthopedic planning and endovascular navigation portfolio
• Demonstrate solutions both in person and online, showcasing clinical value through interactive demos, workshops, and webinars

• Collaboration on S1 and S2 work, including work with virus-containing material after appropriate training
• Cultivation and handling of cells, including work on a larger scale up to 25L (working with various bioreactor systems)

• Develop IRT System specifications to meet the needs of the study design in collaboration with Clinical Trial Supply Unit (CTSU) functions, Medical, Clinical Data Management and Biostatistics
• Select IRT Vendor and create study specific contract

Support of planning, managing and steering of timelines, costs and scope of Trial Teams for agreed deliverables of global supply chain activities for assigned clinical trials, including highly complex trials (e.g. Mega trials, adaptive trial design, digital trials, trials fully outsourced to a...

• Support GxP compliance of all activities in the clinical trial supply management, drug-related distribution and storage
• Responsibility for the project-related GxP documentation and maintenance of lists

• Provide support to complete product dossiers, technical files and responses to information requests
• Coordinate and complete documents required by federal agencies, incl. maintaining complex files and electronic document management systems
• Work with project teams to obtain approval for company products

Responsible for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international Phase I-IV clinical trials in the Therapeutic Area General Medicine...

Performing wet chemical, instrumental, or bioanalytical methodsfor in-process controls, release and stability testing for raw and starting materials, intermediates, as well as consumables and packaging materials according to test instructions/protocols...

• Independently leading all activities from assessment, planning, and conceptual realization to implementation, review, maintenance, and decommissioning of study-specific IRT concepts
• Acting independently as an IRT representative in cross-organizational and cross-functional study and project teams

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

Provide comprehensive In-patient clinical case management for a patient where they will be completing status reports upon admission and whilst the patient remains admitted to the provider....

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Drive innovation by evaluating and continuously advancing therapies through aerosol inhalation
• Communicate scientific insights effectively and foster strong interdisciplinary collaborations to ensure successful translation into clinical practice

• Be the go-to expert for all customer and team inquiries related to BSH Gantry & Consumables
• Support sales with quotations, order processing, tracking, and invoicing
• Coordinate projects, focusing on timelines, resources, budgets, and status reports

Strategic Account Planning: Own and lead the development and execution of robust, insight-driven key account plans aligned with national brand strategy and local market dynamics....

Lead the evolution of the KAM team into a high-performance organization through clear vision, empowerment, coaching excellence, and a culture of continuous learning and improvement, by consistently applying and exemplifying Jazz’s high-performance practices....

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...