Senior Regulatory Systems Manager - Home Based at Pharmaceutical Research Associates, Inc.

Posted in Information Technology 7 days ago.

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Location: Raleigh, North Carolina





Job Description:

Pharmaceutical Research Associates, Inc.

Senior Regulatory Systems Manager - Home Based

US-Remote


Job ID: 2020-64147
Type: US
# of Openings: 1
Category: Regulatory Affairs

PRA Health Sciences

Overview

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.



Responsibilities

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.



Qualifications

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.

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