Regulatory Affairs Application Support (DocuBridge, CARA) Top Pharma

Compliance Services - Frankfurt, Basel, United States

About Arcondis

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create 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.

About us

Open Position

Mission

Tasks and responsibilities

For one of our key clients, one of the most sought-after pharma companies, we are looking for a Regulatory Affairs Application Support to

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

Studies

Your profile

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
Ideally experience with at least one of the following applications:
DocuBridge
CARA
Veeva Vault
TIBCO Spotfire GxP
TIBCO Exploratory
SAS
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
Intrinsic motivation to making healthcare better around the globe