Luke Balmelli-Everhart Email & Phone Number

Philadelphia, Pa, Us

Mainz, Rhineland-Palatinate, De

Plymouth Meeting, Pa, Us

• Regulatory Operations lead for Inovio’s immuno-oncology programs (6 studies)• Lead publisher for all document formatting, submission compilation and submission-level publishing i.e., hyperlinking, bookmarking and eCTD lifecycle operators• Project lead for the Health Canada pilot to submit CTAs in eCTD format• Develop and refine Regulatory Operations standards and processes for submissions, enhancing the quality and timeliness of submission compilation• Create SOPs to ensure consistency throughout the Inovio regulatory organization and manage the biennial review of existing SOPs• QC non-regulatory SOPs for technical accuracy, completeness and clarity• Educate and train functional areas on maintaining Inovio’s submission requirements, including use of templates and authoring tools, such as DocXTools and EndNote• Manage and coordinate the maintenance, review and compliance of all Investigator’s Brochures and Development Safety Update Reports for all Inovio studies• Collaborate with Inovio management and vendors to implement and support new technologies

Plymouth Meeting, Pa, Us

Advocate for GlobalSubmit clients as a technical lead throughout the sales cycle, both customer facing and behind-the-scenes: from collaborating with the GlobalSubmit marketing team as a technical resource for RFI and RFP requests and leading technical demonstrations during the pre-sales cycle. Once on-boarded, guide new clients through the installation, validation, implementation and training requirements for the software suite. Provide post-sales support as needed after the initial set-up period.Manage technical documentation and training programs to enhance customer satisfaction and comprehension during software training and decrease the frequency of post-implementation support requests through many mediums, including: text based user guides, computer based trainings, PowerPoint slide decks and windows CHM help files. Worked with a team to manage documentation creation for two brand new software product lines. Proofread and edit existing content for clarity and readability.Facilitate software improvements by providing customer feedback to development for bug issues and enhancement requests. Ensure maximum quality of work by performing exploratory, experience-based testing of alpha and beta builds of new software builds. ISTQB certified in software testing, foundation level. Work extensively with external vendors to vet and test process-improving software and services. Provide technical and usage fact comparisons and recommendations to management based on the information gathered for vendor selection. Small scale/maintenance SFDC administration including reporting.Work with SaaS (hosted by Amazon AWS) and on-premise versions of the software.

Bilingual support for IT administrators with technical issues relating to Mobile Device Management, particularly as a SME for Windows Phone, Blackberry and Mac OSX. Assisted with implementation of proprietary software. Educated new and junior support team members on best practices, troubleshooting steps of technical issues and achievement of resolutions. Worked with management on special projects and internal documentation as needed.

Denver, Co, Us

Assisted clinicians in technical issues surrounding proprietary clinical applications. Performed general technical support, as well as specialized hardware installations, documentation and training new employees. Part of a team that worked with new acquisitions as they integrated with DaVita. Ensured optimal resolution of issues and customer satisfaction.

Philadelphia, Pa, Us

General Tier 1 technical support- Password resets, triaged larger issues, documented issues.