Regulatory Systems Specialist
- Experience Level
- Experienced (non-manager)
PRA and our employees have won numerous awards and accolades in the CRO industry and 2020 hasn’t been any different with gold winners in the Project Manager and Clinical Research Team of the Year at the Pharma Times awards! We have won multiple awards across Europe, The America’s and Asia Pacific including BioPharma Asia/Phar-East Best CRO, Pharma Times Clinical Company of The Year and special recognition at the Vaccine Industry Excellent Awards.
As a Regulatory Systems Specialist, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors PRA’s commitment to career development.
You will be responsible for:
- Assisting users with the resolution of simple to moderate problems associated with regulatory affairs systems
- Delivering 1:1 or group training to end users
- Maintaining and developing supporting materials / tools for regulatory affairs system applications
- Managing end user access requests for regulatory systems
- Identifying trends in end user issues and escalating for resolution.
- Focusing on supporting publishing systems
Qualifications and Experience:
- Regulated Pharma/CRO industry experience.
- Knowledge of Regulatory Affairs/Operations business and/or systems
- Excellent organizational, communication, and time management skills a must
- Able to work well with peers, clients, buyers and partners
- Intermediate knowledge of regulatory affairs principles, processes and regulations
- Working knowledge of the software development life cycle and software development methodologies
- Ability to determine unstated user needs through application of functional knowledge
- Ability to learn new applications, processes and procedures of varying complexity
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
For more information please visit our website: www.prahs.com
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