Allyn Selesky
Fort Lauderdale,FL
Summary
Energetic, well-spoken, highly competent Regulatory Systems professional with over 15 years industry experience. Worked to implement and manage a variety of Regulatory Systems with specific expertise in Veeva's Submissions Vault and Submissions Archive.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Manager, Regulatory Systems
PRA Health Sciences/ICON
06.2017 - Current
- Provides consulting services to various pharmaceutical clients worldwide for implementing and managing large submission information management systems
- Works across multiple teams to plan, develop, track and implement IT solutions
- Acts as a liaison between various business, technology and vendor stakeholders to ensure alignment across all relevant organizations
- Oversees the delivery of applications to ensure solutions meet business objectives
- Extensive experience with SDLC methodologies and computer systems validation within a pharmaceutical environment
- Experience with system-to-system data migrations
- Experience in all aspects of regulatory systems support that ranges from project initiation and planning activities, requirements gathering and business process development, configuration and testing, through system training including the development of system-specific policies and procedures
- Unique ability to translate and communicate complex concepts across various audiences
- Experience with project management tasks to ensure projects meet budget and timeline expectations.
Senior Regulatory Business Analyst
Calculated Technologies
06.2016 - 05.2017
- Supported client for business support during the migration of content for their Global Document Management System
Senior Product Expert
CSC
05.2011 - 05.2016
- Worked on various client projects to implement FirstDoc systems and supporting technologies
- Otsuka Pharmaceuticals, Business Analyst: Global validated document management system implementation
- System included the following applications: FirstDoc, Input Accel, Documentum’s IRM and a multi-region data migration
- BTG International, Project Manager: Local validated document management system implementation
- System included the following applications: FirstPoint and Sharepoint
- Watson Pharmaceuticals, Business Analyst: Multi-region Regulatory Tracking system implementation
- System included the following applications: TRS Tracker, TRS Viewer and a multi-region migration
- Takeda Pharmaceuticals, Subject Matter Expert: Supported requirements analysis by providing FirstDoc subject matter expertise during global system planning meetings
- TRS Tracker internal project team, Business Analyst: Update and manage user requirements specifications, configuration specifications documents
- Support testing activities and update user training materials
- FirstDoc User Interface internal project team, Business Analyst: Update end-user training materials and internal project documentation.
IT Business Analyst
Takeda Pharmaceuticals
05.2001 - 04.2016
- Worked as Business Analyst to support various R&D business systems and functions
- Worked on all system and validation documentation
- Worked with the business community to define and develop efficient business processes to align with technology solutions
- Followed industry standards, new initiatives, and regulations to ensure solutions are compliant with external agency requirements and evolving processes.
Education
Bachelor of Science - Marketing
Northern Illinois University
DeKalb, IL12.1995
Skills
- Strong Teamwork and Collaboration
- Detail Oriented
- Thrives in a fast-paced environment
- Successfully manages multiple priorities
- Good oral and written communication
- Ability to work across different functions and levels across an organization
- Computer Systems Validation
- Project management skills
Certification
Veeva Vault White Belt certification
Timeline
Manager, Regulatory Systems
PRA Health Sciences/ICON
06.2017 - Current
Senior Regulatory Business Analyst
Calculated Technologies
06.2016 - 05.2017
Senior Product Expert
CSC
05.2011 - 05.2016
IT Business Analyst
Takeda Pharmaceuticals
05.2001 - 04.2016
Bachelor of Science - Marketing
Northern Illinois University