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Regulatory Support Consultant (m/f/d)
Location: United States (Remote)
Responsibilities
- Serve as the first point of contact for customer questions and inquiries on a range of different LORENZ products and services through the LORENZ support line via calls, emails and/or current open tickets
- Answer functional, technical and eCTD validation questions submitted by customers
- Perform trouble shooting sessions, replicate issues and discuss resolution processes with customers
- Work with LORENZ’s support processes and tools to accurately log and update tickets, and follow up with customers as needed
- Correctly identify and redirect issues to other teams as needed
- Manage customer communications effectively and collaborate with account managers and development team members closely to achieve high customer satisfaction
- Work on other related technical projects as needed
As a Regulatory Support Consultant with LORENZ’s North American team, you will provide post implementation support to LORENZ’s customers in the US and Canada
Requirements:
- Bachelor’s Degree in Computer Science, Regulatory Affairs, or other related disciplines
- Must be authorized to work in the US
- Must reside in the US (does not include CA, CO, IL, MD, NY, and WA residents)
- 3+ years of experience as a Business System Analyst (strongly preferred) or other related roles in IT, regulatory affairs, and regulatory information management
- Experience with document management, submission management and product information/life cycle management preferred
- Proficient in client-server application deployments and cloud-based system deployments (AWS or Azure)
- Basic knowledge of database systems (SQL) and XML languages
- Prior experience in validation processes with an understanding of validated environments, IQ, OQ and PQ documentation
- Knowledge of JIRA or similar ticket management tools
- Ability to communicate effectively with customers
- Ability to work under pressure, both independently and in a distributed team environment to resolve customers' issues
- This role may require maintaining a seated position for extended periods or standing for prolonged periods when performing tasks
We offer:
- Fully remote; work from home
- Flexible work schedule
- International work environment: We offer opportunities to work with customers and colleagues around the globe and travel the world to connect with end users at conferences and meetings
- Modern workstation set up: Brand new, high end laptop for each new employee
- Monthly home office and cellphone stipend
- Generous paid vacation which increases based on years of service and paid sick leave
- 10 paid public holidays annually
- Comprehensive health insurance plan: LORENZ covers 90% of employees' self-only insurance plans and 70% of employees' family insurance plans
- 401K match up to 4%
- Professional development stipend
- Employee referral bonus up to $5,000
- LORENZGives: Each employee receives $500 and 2 working days per year to donate to a charity of their choice
- Birthdays, holidays and work anniversary celebrations and so much more
LORENZ is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
