Support Analyst with Regulatory Biotech or Pharma Experience (ECTD)

Remote position must be East Coast based.

Responsibilities:

• Serve as the first point of contact, answer and resolve questions coming into the support line from calls, emails and/or current open tickets on a range of different SW products and services.
• Be able to answer functional, technical and validation questions and explain to customers the differences if/when asked
• Replicate the problem, walk the customer through his/her problem solving process, perform remote trouble shooting and inform customer of next steps
• Work within the current support processes and tools already in place.Accurately log and update tickets, and follow up with customers as needed
• Correctly identify and redirect issues, collaborate with account managers and development team members to facilitate customer satisfaction and follow up as needed
• Manage customer communications with effective written and verbal communication skills.

Qualifications:

• Bachelor’s Degree in Computer Science, Regulatory Affairs or other related discipline.
• 3+ years of experience as a Business System Analyst (strongly preferred) or related role in IT, regulatory affairs and regulatory information management, especially document management, submission management, product information/life cycle management.
• Expertise in “Client-server applications, virtualization platforms, database systems (SQL), PDF, cloud-based systems (AWS or Azure) and XML Language
• Prior experience in validation processes and an understanding of validated environments, IQ, OQ and PQ documentation.
• High comfort level in communicating remotely and resolving issues under time pressure
• Knowledge of JIRA or similar issue management tool