Job ID: 2020-64147 Type: US # of Openings: 1 Category: Regulatory Affairs
PRA Health Sciences
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring, join us and Discover Your PRA.
Who are we?
We Are PRA.
We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting life saving drugs into the hands of those who need them most.
Who are you?
You are a leader that isn’t afraid to delegate but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate regulator and are an excellent communicator. You have a serious passion for content and document management. You never settle for what is but are always pushing regulatory forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place you love working where you’re more than an employee number.
Still here? Good. Because if this is you, we’d really like to meet you.
What you will be doing:
Senior Business Analyst, Regulatory Technology
Act as a subject matter expert for PRA’s regulatory technology, including the Veeva regulatory platform
Working on regulatory technology projects, provide subject matter expertise on business setup and use of regulatory systems
Work with clients to document business regulatory system requirements
Using business system requirements, create and execute User Acceptance Test cases, with or without client representation
Create as-is and to-be business process flows and make best-practices recommendations
Act as a change agent, communicating the benefits of processes, tools, and systems and gaining buy-in and acceptance from the user community
Create and deliver end user training to business users
Work closely with the User Management team during the initial transition to support following go live
Provide expertise and support for client migration activities, including mapping and verification
Within PRA, participate on the Vault deployment team to ensure that the required documentation is in place, end user training is complete and documented, and participate in release management activities.
What you need to have:
10+ years of business analysis experience in a Regulatory environment
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, with a particular emphasis on document and content management systems
Experience working with the Veeva platform preferred, but not required
Experience creating and facilitating end user training
Experience participating in and facilitating configuration workshops
Experience working with third party software vendors to understand system capabilities
Consulting experience a plus
Desire to work in a fast-paced environment, working one-on-one with clients and PRA project teams to implement regulatory technology
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.