Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Solution Delivery
Regulatory Affairs Application Support
- Provide application support to key users for the eDMS, RIMS and eSM platforms (e.g., business functional operations, high-level data analytics, data management, change management)
- Work with IT and external vendors to troubleshoot technical issues and coordinate system updates
- Support system data management activities, e.g. master data management, data quality, security and integrity, preparation and implementation of data-related changes
- Technically support between the handling of operative master data, operative business units and regulatory units
- Create and maintain all User Requirement Specifications and Quality Control documents as required by SOPs and Processes
- Analyse, manage, and align on solution releases e.g. process and data requirements, as well as the design, tests scripts authoring and execution
- Lead business operations impact assessments and industry best practices implementation
- Federate the user community proactively engaging on new regulatory changes being implemented in the eDMS, RIMS and eSM systems
- Lead business operations impact assessments and other industry best practices
1
- Bachelor’s or higher degree in a scientific discipline (e.g. computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science)
- Knowledge of systems in the Regulatory Affairs domain, incl. Regulatory Information Management, electronic Document Management and Publishing Management systems with demonstrated experience in managing support and demand needs for these systems
- Extensive knowledge of Regulatory Affairs (GRA) business domain and GRA business processes & data management
- Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions
- Familiar with regulatory data standards - IDMP/XEVMPD
- Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions
- Some working experience in the Regulatory Affairs area might be beneficial
de3351a6-f509-4ff8-8d65-639011a6b60d
445cef6c-0f04-4642-a23f-09b101505d0a
Kosice
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Solution Delivery
- Provide application support to key users for the eDMS, RIMS and eSM platforms (e.g., business functional operations, high-level data analytics, data management, change management)
- Work with IT and external vendors to troubleshoot technical issues and coordinate system updates
- Support system data management activities, e.g. master data management, data quality, security and integrity, preparation and implementation of data-related changes
- Technically support between the handling of operative master data, operative business units and regulatory units
- Create and maintain all User Requirement Specifications and Quality Control documents as required by SOPs and Processes
- Analyse, manage, and align on solution releases e.g. process and data requirements, as well as the design, tests scripts authoring and execution
- Lead business operations impact assessments and industry best practices implementation
- Federate the user community proactively engaging on new regulatory changes being implemented in the eDMS, RIMS and eSM systems
- Lead business operations impact assessments and other industry best practices
1
- Bachelor’s or higher degree in a scientific discipline (e.g. computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science)
- Knowledge of systems in the Regulatory Affairs domain, incl. Regulatory Information Management, electronic Document Management and Publishing Management systems with demonstrated experience in managing support and demand needs for these systems
- Extensive knowledge of Regulatory Affairs (GRA) business domain and GRA business processes & data management
- Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions
- Familiar with regulatory data standards - IDMP/XEVMPD
- Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions
- Some working experience in the Regulatory Affairs area might be beneficial
de3351a6-f509-4ff8-8d65-639011a6b60d
445cef6c-0f04-4642-a23f-09b101505d0a
Kosice