Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Application Support Specialist - Burg AG - Arcondis
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Qualification & Validation Consultant
vor 3 Wochen
Burg AG, Schweiz Arcondis VollzeitArcondis 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...
Regulatory Affairs Application Support Specialist
vor 2 Monaten
Arcondis, a global consulting company with a focus on healthcare and life sciences, is seeking a skilled professional to provide application support for our eDMS, RIMS, and eSM platforms.
Key Responsibilities:- Provide technical support to key users for the eDMS, RIMS, and eSM platforms, including business functional operations, high-level data analytics, data management, and change management.
- Collaborate with IT and external vendors to troubleshoot technical issues and coordinate system updates.
- Support system data management activities, such as master data management, data quality, security, and integrity, as well as preparation and implementation of data-related changes.
- Technically support the handling of operative master data, operative business units, and regulatory units.
- Create and maintain User Requirement Specifications and Quality Control documents as required by SOPs and Processes.
- Analyze, manage, and align on solution releases, including process and data requirements, design, test 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.
- Bachelor's or higher degree in a scientific discipline, such as computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science.
- Knowledge of systems in the Regulatory Affairs domain, including 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.
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. We have a global footprint with offices in North America, APAC, and across Europe. Our focus lies in creating value for our clients through our expertise in compliance, business processes, information technology, and digital transformation. We are owned by a charitable Foundation and contribute to social causes every year. Our motto, "We make healthcare better," reflects our commitment to improving the lives of people through our work.
