Operations consultant állások, munkák egészségügy, gyógyszeripar területen

Analyze customer requirements and support solution design and architecture of trial sponsors or contract research organizations (CRO) in Vault Clinical (e.g., eTMF, CTMS, SSU, Payments, etc.)...

Organize and coordinate internal and external learning and training activities - from planning and scheduling to attendance management and training evaluation. ...

• Developing the medical strategy our partner in Hungary
• Medical support and/or execution of local product strategies
• Scientific differentiation of the portfolio products versus competitors
• Providing consultation on indication- and product-related professional matters

• Responsible for receiving/downloading information from different channels and receiving voice calls for reporting safety information.
• Route information/safety reports to appropriate Department (e.g. medical information, quality assurance) as applicable.

• 40 hours per week
• Normal business hours
• Office attendance: Once a week
• Tracking different regulatory submissions in the corporate regulatory database – update database with specific documents and/or information
• Running daily queries, providing reports to client stakeholders

• Develop, modify, and maintain quality evaluation and control systems for materials, in-process parts, and finished products.
• Translate product requirements/specifications into test plans, methods, and fixtures to ensure product reliability.

• Responsible for receiving/downloading information from different channels and receiving voice calls for reporting safety information.
• Route information/safety reports to appropriate Department (e.g. medical information, quality assurance) as applicable.

• Responsible for receiving/downloading information from different channels and receiving voice calls for reporting safety information.
• Route information/safety reports to appropriate Department (e.g. medical information, quality assurance) as applicable.

• Coordinate laboratory projects and daily laboratory activities
• Schedule and monitor laboratory tasks and deadlines
• Prepare, manage and maintain laboratory documentation
• Handle technical documentation and certificates
• Prepare regular reports and summaries related to laboratory activities

You will be a focal point for our customers, on how to best align their transformational business & IT initiatives with our SAP portfolio, partner solutions and the latest product developments, for achieving the best outcomes and value for their day-to-day operations....

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)...

• Acting as a trusted advisor and thought partner to the Head of Technology Unit in decision-making, prioritization, and execution of key initiatives.
• Managing critical projects and ensuring alignment with business goals and objectives.

Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to execute translational science strategies in clinical trials....

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...

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• 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

• Development new formulations: contribute to design of studies, perform experiments and prepare reports
• Develop analytical methods (e.g. HPLC)
• Prepare and characterize large number of formulations following DOE
• Assist in the development of methods to characterize formulations or raw materials

• Working with high throughput lab – analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• Plan and execute different work packages for the development of molecular diagnostics test