Regulatory Systems Manager
- Experience Level
- Experienced (non-manager)
As a Regulatory Systems Manager, 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.
Your responsibilities will be to:
- Act as a subject matter expert for PRA’s regulatory technology, including Liquent Insight Publisher
- Working on regulatory technology projects, provide subject matter expertise on business setup and use of regulatory systems
- Perform analysis and design on publishing initiatives and systems projects supporting business facing activities, e.g. requirements analysis, UAT, data migration / cleansing.
- Drives the resolution of complex / escalated problems associated with internal and client publishing systems.
- Create as-is and to-be business process flows and make best-practice recommendations
- Act as a change agent, communicating the benefits of processes, tools, and systems and gaining buy-in and acceptance from the user community
- Support the creation and delivery of end user training to business users
- Provide expertise and support for client migration activities, including mapping and verification
- Extensive experience of business analysis experience in a Regulatory Operations environment
- Expertise in publishing technology, ideally include Insight Publisher, eCTDXpress, TRS, Docbridge, and connectors with EDMS (FirstDoc / Veeva)
- Knowledge of Regulatory Affairs and Operations and the systems that support the function
- Direct experience working with Regulatory clients to implement new or enhance existing systems
- Experience working with the Veeva platform preferred, but not required
- Desire to work in a fast-paced environment, working one-on-one with clients and PRA project teams to implement publishing technology
- Excellent organizational, communication, and time management skills
- Able to work well with peers, clients, partners and stakeholders
Your health, your family, your career, your money — the things that matter to you, matter to us. We consider part time or full time working.
The benefits of PRA just keep getting 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