Regulatory Information Specialist
- Experience Level
- Experienced (non-manager)
PRA Health Sciences are an award winning CRO.
We are proud to have won Pharma Times “Clinical Research Company of the Year” in 2017 for the fourth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.
As a Regulatory Information 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.
In this role you will be responsible for entering data in the company’s Regulatory Information Management (RIM) system(s) and carry out remediation activities for known data quality issues. You will also be responsible for:
- Establishing and maintaining regular contact with information providers, verifiers, and key stakeholders.
- Identifying internal process issues/risks/ deficiencies to senior information specialist.
- Overseeing submission of data and supporting documentation to external agency databases (i.e. XEVMPD) in compliance with agency requirements.
- Identifying, logging, and tracking issues raised by information providers and team members through to resolution.
- Collaborating with other submission and information management functions to review requests and identify recurring issues and trends; identifying the need for business process/system change and making recommendations to line management accordingly.
- Ensuring line management is notified of changes to relevant agency guidelines/ regulations found during daily processes
- Supporting development of education offerings (training materials, quick reference guides etc.) to support accurate, timely and reliable entry of data into the company’s RIM systems/external agency databases
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To be successful in this Regulatory Information Specialist position, you will need to have:
- Regulated Pharma/CRO industry experience.
- Proven experience in Regulatory Information Management and knowledge of Regulatory Affairs/Operations business and/or systems
- Working Regulatory Technology experience (RIMS)
- Ability to multi-task and work well with peers, clients, buyers and partners
- Excellent organisational, communication, and time management skills
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 Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com
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