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The Regulatory Solutions Business Analyst will be responsible for the end user support of technology solutions and the timely delivery of associated technology change projects and programs.
What will you be doing? As a Regulatory Solution Analyst, you will be responsible for the end user support of technology solutions and the timely delivery of associated technology change projects and programs. This team is made up of 2 sub teams; regulatory solutions analysis and project management.The Regulatory Solutions analysis sub team provides business analysis and end user support for all the solutions owned and managed by Global Regulatory Affairs. The core regulatory solution areas are:
Document management , e.g. EDMS, document archiving solutions, etc
Publishing, e.g. publishing, eCTD validation, viewing tools, etc
Regulatory planning and tracking, e.g. submission planning, tracking of registrations, tools for commitment management
Regulatory Information Management, e.g. XEVMPD, IDMP solutions
Regulatory intelligence, e.g. Q&A databases and sharepoint sites
Regulatory solutions analysis ensures that the systems used within GRA are fit for purpose, well understood and supported by a team of process and system experts. The function underpins our ability to run effective and efficient processes using a simplified set of tools.This team promotes a global e-working environment and drives efficient, standardized best practices for regulatory technology solutions. In this role, the Regulatory Solutions Analyst will provide operational end user support, create pre-agreed communications to users, and understand current business process in local area of expertise. The role is operational in nature and its positive impact on the end users within the GRA function is significant and will be expected to manage their own workload.Understanding the regulatory suite of tools and possessing end user support skills, this role will support end users of regulatory solutions in their day to day use.
Provide timely, cross functional, cross regional, and country level (LOC RA) end user training, process and systems support
Provide support in the form of daily direct contact either in person, on the phone, in teleconferences and via telepresence
Building a solid understanding of at least 1 of the core regulatory solutions
Understanding and be able to clearly explain how to follow current processes and use current systems in at least one regulatory solution
Understanding all the support tools available for at least 1 of the core regulatory solutions and is able to explain these tools to end users
Working with IT to triage and troubleshoot support tickets taking responsibility for resolving business process and end user support related issues
Execute the process to provide end user access to core regulatory solutions
Working with end users to understand their requirements
Working with IT to create, maintain and retire user accounts
Review, prioritize and respond to end user issues, escalating complex issues appropriately. Tracks queries to completion ensuring that the query was fully resolved prior to closure
Support system maintenance activities to ensure the system remains in a validated state and users are aware of the support activities
Maintain communications to end users to ensure that they are aware of the regulatory solutions status
Sizeable pharmaceutical industry experience
Experience working within Regulatory environment. Broad experience in at least 1 of the regulatory solutions areas
Experience providing end user support for at least 1 core regulatory solution
Knowledge of GRA processes and systems; for example document management, regulatory submissions, publishing, registration tracking, information management
Background in Global Regulatory Affairs as well as understanding of European, US and international regulations
Able to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
Able to multitask in a deadline controlled and highly regulated environment; prioritizing own workload
Able to understand and support the drug development and regulatory dossier creation, review and approval process
Excellent listening and communication skills; able to clearly and concisely express oneself to end users from a variety of technical and cultural backgrounds
Strong team working skills; able to perform in a distributed global team
Strong interpersonal skills as the candidate will be required to support and work Qualified project management experience
Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes
Solid understanding of document management systems and concepts
Experience of multitasking in a dead-lined controlled and highly regulated environment
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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