Regulatory Systems Manager - Remote Based in the US

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

As a Regulatory Solution Manager, you will be responsible for the business analysis of regulatory technology solutions, business processes, supporting timely delivery of associated technology change projects and programs.  As a part of the Regulatory Solutions Analysis team within Global Regulatory Operations, this role provides business analysis and end user support for all the solutions owned and managed by Global Regulatory Affairs. The core regulatory solution areas are:

• Document management , e.g. EDMS, document archiving solutions, etc
• Publishing, e.g. publishing, eCTD validation, viewing tools, etc
• Regulatory planning and tracking, e.g. submission planning, tracking of registrations, tools for commitment management
• Regulatory Information Management, e.g. XEVMPD, IDMP solutions
• Regulatory intelligence, e.g. Q&A databases and sharepoint sites

Regulatory solutions analysis ensures that the systems used within GRA are fit for purpose, well understood and supported by a team of process and system experts. The function underpins our ability to run effective and efficient processes using a simplified set of tools.

This team promotes a global e-working environment and drives efficient, standardized best practices for regulatory technology solutions.

In this role, the Regulatory Solutions Manager will provide operational business analysis in support of our global end user community, understanding current business process within Global Regulatory Affairs, and providing guidance for business process best practices in integrated use of regulatory solutions.  The role is operational in nature and its positive impact on the end users within the GRA function is significant; a successful candidate will manage their own workload and prioritize demands. Detailed understanding of the regulatory suite of tools in use is required.  

• Provide timely, cross functional, cross regional, and country level (LOC RA) regulatory business process development and systems support
• Provide business process analysis in the form of daily direct contact either in person, on the phone, in teleconferences and via telepresence
• Building a solid understanding of the suite of core regulatory solutions
• Developing and optimizing business processes and use of current systems
• Understanding related business processes and suggesting process efficiencies to create smooth and integrated user experience in regulatory solutions
• Representing business needs in systems implementation, upgrade, and validation activities
• Working with the business end users and IT to develop detailed User Requirements in support of systems validation activities
• Working with the business end users, IT, and Quality organizations to execute User Acceptance Testing in support of systems validation activities
• Review, prioritize and respond to escalated  end user business process issues. Tracks queries to completion ensuring that the query was fully resolved prior to closure.
• Support system maintenance activities to ensure the system remains in a validated state and users are aware of the support activities
• Maintain communications to end users to ensure that they are aware of the regulatory solutions and associated business process status

What do you need to have?

Education:  Bachelor’s Degree is required. 

Skills: Experience

• • 2 Years of experience
  • Sizeable pharmaceutical industry experience
  • Experience working within Regulatory environment
  • Broad experience working with Liquent InSight Regulatory Information Management solution
  • Experience developing end user business process for regulatory solutions
  • Detailed understanding of and experience in systems validation in a pharmaceutical environment
  • Experience gathering end user requirements, authoring User Requirements Specifications and User Acceptance test scripts; experience executing User Acceptance test scripts
  • Knowledge of GRA processes and systems; for example document management, regulatory submissions, publishing, registration tracking, information management
  • Background in Global Regulatory Affairs as well as understanding of European, US and international regulations
  • Able to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
  • Able to multitask in a deadline controlled and highly regulated environment; prioritizing own workload
  • Able to understand and support the drug development and regulatory dossier creation, review and approval process
  • Excellent listening and communication skills; able to clearly and concisely express oneself to end users from a variety of technical and cultural backgrounds
  • Strong team working skills; able to perform in a distributed global team
  • Strong interpersonal skills as the candidate will be required to support and work Qualified project management experience
  • Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes
  • Solid understanding of document management systems and concepts
  • Experience of multitasking in a dead-lined controlled and highly regulated environment

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.