Brenda Hunsberger Email & Phone Number

Malvern, PA

Malvern, Pennsylvania, United States

Frazer, Pennsylvania

• Conducted global regulatory operations within Regulatory Affairs that encompasses the successful handling of many diverse responsibilities.
• Directed two successful projects from requirements gathering to launch for successful online request tools used department–wide to ensure an improvement time for Certificates of Pharmaceutical Products (CPP) and User.
• Effectively reviewed, re-wrote, and updated department’s Standard Operating Procedures (SOP) in Learning Management system.
• Successfully maintained and updated Regulatory Affairs Department SharePoint sites, database management, granting permissions, troubleshooting, and site development.
• Conducted reporting metrics/tracking: Regulatory Training, FDA User Fees paid, CPPs issued, PLAIRs issued, and Site Registrations.
• Managed and and facilitated Regulatory Professional Learning sessions for Global Regulatory Affairs and business partners. Provided support and editing expertise for Regulatory Affairs monthly newsletter.

Frazer, PA

• Successfully maintained and updated SharePoint sites for Project Approval Committee (PAC), Long Range Planning (LRP), and multiple Team sites. Skilled system administrator for the department’s SharePoint sites..
• Directed administrative support for Vice President, Sr. Director, Director, and staff on day-to-day activities.
• Executed beyond daily administrative responsibilities to include compilation, editing, and refining the Monthly Status report to showcase pipeline projects.

Collegeville, Montgomery County, PA

• Facilitated the administration of various tools and systems used by Pfizer’s portfolio planning staff for new and continuing drug candidate projects.
• Managed creation of step-by-step user manuals and quick reference guides for IT systems and tools.
• Improved new hire training for various systems by creating and implementing e-learning modules that enhanced training by providing “as-needed” training for employees.
• Successfully tested for system bugs and provided feedback/suggestions for product enhancements for testing of Snapshot, iPort (interactive portfolio tool), Medical Implementation Plan, and others that enabled a better.
• Skilled system administrator for the department’s SharePoint sites. Conducted Lunch and Learn demos for department to familiarize colleagues with new or upgraded functionality.

Collegeville, Montgomery County, PA

• Conducted as system analyst and administrator for project planning system used by Project Management and Clinical Business departments.
• Assisted with the initiation and implementation of a comprehensive tracking and planning system (Pro-MAP) used for project planning, status reports, and tracking clinical cost and resources.
• Collaborated with Information Technology (IT) colleagues for change control and new releases for planning system. Conducted extensive testing for system bugs on upgrades and enhancements prior to releasing to Project.
• Improved the quality and content of monthly pipeline project status reports that were distributed to executive and senior management staff.
• Created, updated, and issued step-by-step system user manuals and e-learning modules.
• Selected by management as the Project Management’s eRoom coordinator. Oversaw organization, content, and access control of eRoom structure.