Ogłoszenie numer: 4345447, from 2021-03-22
Phlexglobal is a specialist provider of document management solutions and other support services to the global clinical research market. We have offices in the UK and the US, as well as Lublin, to serve the needs of our global customers.
We are looking for:
Regulatory Affairs Consultant
Location: lubelskie, Lublin
Job description
Recruitment: remote
Workplace: Lublin office (with remote work possibility)
Phlexglobal is a specialist provider of document management solutions and other support services to the global clinical research market. As a Regulatory Consultant, a large portion of your time you will be working with customers, answering their questions, and helping them to analyze regulatory and functional challenges they may be experiencing.
What responsibilities you will have:
- Work with customers to answer questions and/or resolve process or technology-related challenges within their Cunesoft environment
- Analyze and respond to customer support tickets with solutions within established timeframes
- Collaborate with the technical team to determine technical solutions
- Actively communicate technical and regulatory solutions to customer
- Document issues, status, and resolutions within established systems
- Understand customer requirements and document these as business requirements for new software functionality
- Train users via web meetings as required
- Participate and assist with testing, configuration/release management, deployment as well as validation
- Demonstrate software in support of requirements gathering as well as occasional sales support
Requirements
You fit us perfectly if you have:
- 3 - 5+ years of direct experience as regulatory consultant / support consultant with regulatory computer systems for eCTD and/or xEVMPD and/or RIM and/or DMS systems
- Excellent English skill
- Understand regulatory requirements for eCTD publishing
- Understand and previous experience with GxP and/or 21 CFR Part 11
- Ability to lead customer-facing web meetings with end users, but also senior level participants
- A good and solid understanding of regulatory processes and procedures
- A good understanding of regulatory software
We offer
- Regular performance reviews to help you to achieve your career development goals
- Possibility of remote work
- Flexible working arrangements
- Good atmosphere at work with highly motivated and integrated team
- Great benefits (MyBenefit, private healthcare, English language training, pension and life assurance)
- Employment in an international company with offices in the UK, US, Germany and India