Bridget Kelly
Leland
Summary
Dynamic project specialist with a proven track record in coordinating and managing diverse project activities to ensure seamless execution and delivery of results. Expertise in scheduling, budget management, and stakeholder communication fosters a collaborative team environment that drives success. Recognized for maintaining high standards and a results-driven approach, consistently optimizing office operations while adapting to evolving project demands. Strong organizational, communication, and multitasking skills contribute to achieving objectives and enhancing overall team performance.
Overview
17
17
years of professional experience
Work History
Project Coordinator, Medical Writing
Ultragenyx (contract)
10.2021 - 07.2022
- Responsible for project management and maintenance of Medical Writing and Publications functional and company facing SharePoint sites
- Responsible for managing and tracking publication timelines across all programs at Ultragenyx (includes conference abstracts, posters, presentations and manuscripts)
- Responsible for ensuring appropriate documentation and archival of author approvals and final presentations/publications
- Maintain a list of vendor Pos and contracts and coordinate timely updates as needed
- Provide high level administrative and program management and support
Executive Assistant, Commercial & Corporate Communications
Atara Bio (contract)
08.2020 - 10.2020
- Managed the CCO and the teams’ calendars, which included using judgment to negotiate and maximize managers’ use of time while addressing the needs of the organization, as well as anticipating and resolving scheduling conflicts. Kept team on track with work commitments
- Worked in Teams to schedule meetings, attend meetings, keep track of projects and utilized to keep in contact and support the entire Commercial Team
- Worked on projects in Visio and Adobe Pro upon request such as organization chart and editable fillable forms
- Utilized planner to help track projects and keep the team up-to-date and in sync for entire commercial team developed the Commercial team group in Planner and laid on channels for working projects
- Submitted Purchase Requisitions and New Vendor forms for all new vendors and consultants
- Used Concur Expense and Travel to submit expense reports and book travel if needed
Assistant to Vice President of Quality, Quality
FibroGen
04.2013 - 06.2019
- Supported Quality Assurance for all GxP projects (domestic and international)
- Supported and served as runner for all GxP audits and inspections (Includes Partners and FDA)
- Worked closely with VP of Quality to create and maintained department budget – providing updates as requested
- Responsible for coding and tracking all department invoices in Invoice Management System
- Responsible for updating and managing Quality Assurance department intranet page using SharePoint
- Work with Salesforce software to create and access company contracts for department
- Reviewed and Tracked Quality Control Stability Testing Work Orders on spreadsheet and send monthly accruals to Finance using company invoice management system
- Tracked all Vendor/Consultant Contract and WO for Quality Department and send monthly accrual updates to Finance with Salesforce database
- Responsible for QA/QC team’s domestic and international travel arrangements
- Responsible for recording and distribution of QA departmental meeting minutes
- Responded as directed to communications on behalf of department
- Maintained Quality department electronic and manual file systems, as needed
- Supported Document Control to maintain Quality training records, as requested Help track and file audit reports, responses, and supporting documentation generated by QA personnel, as requested
- Coordinated all Internal and External Meetings for Quality department and worked with multiple department teams coordinating company events which including food and beverage, room planning, hotel accommodations, AV and any other requests needed to execute a successful event.
- Lead for all department employees; open position candidate correspondence and scheduling, candidate travel logistics and expenses, interview schedule development and maintenance
- Processed all department new hires, including location and technical set up, initial orientation and required training, and coordinating with Doc Control to develop training binder with appropriate curriculum matrix
- Prepared and processed expense reports, department invoices, memos, general correspondence, and other routine documents in a timely manner for all team members.
Senior Administrative Assistant, Medical Affairs Medical Affairs
Theravance (contract)
02.2012 - 11.2012
- Responsible for managing and sharing company’s scientific literature database using Quosa software in creating bibliographies, ordering publications and organizing publications in a shared efile.
- Lead Administrator for the SteepRock (Key Medical Expert Management System) database used to organize and maintain Investigator Initiated Trial documents, tracking spending on Investigators to ensure medical affairs is compliant.
- Responsible for setting up the new ey Medical Expert Management System (Steeprock) by working with Director’s to design system to effectively organize Investigator Trial documents as well as transferred all Phase 4 trial documents from partner back to Theravance
- Responsible for creating all department Workflows using Microsoft Visio
- Responsible for all travel, heavy scheduling and expenses for Medical Affairs team
- Supported departmental managers with planning, vendor management tasks, contract processing, and contract close out, and maintenance of compliance files for assigned advisory boards, investigator meetings, departmental meetings, and congresses as assigned.
- Responsible for tracking and processing contracts, Scope of Works (SOWs), Work Orders (WOs), Letter of Agreements (LOAs), Purchase Orders (PO), Check Requests, and all other documentation necessary to support projects in the Medical Affairs department
Administrative Assistant II, Clinical Operations
BioMarin (contract)
06.2011 - 02.2012
- Ordered, sourced, distributed, and tracked study material for Morquio studies
- Reviewed and maintained Trial Master File (TMF) for ph 2 Morquio Study both electronic and paper
- Scanned and uploaded TMF files into electronic file system and maintained study specific documents
- Responsible for creating and maintaining multiple study trackers
- Required to take meeting minutes for all Morquio team meetings
- Supported study team members (i.e., CRA, CR Assistant, CPM, etc.)
- Planned and supported CRAs for all study Investigator and Team meetings
- Prepared PowerPoint meeting presentations for multiple people
- Entered data and ran reports using the Clinical Trial Management System, TrialWorks
- Responsible for running and distributing bi-weekly management reports using Crystal Reports
- Assistant to the Vice President of Clinical Operations as well as the Senior Director for the Morquio (Enzyme Replacement Therapy) team and the Associate Director of the Firdapse (Lambert-Eaton Myasthenic Syndrome) Team
- Responsible for travel arrangements, heavy scheduling and expenses for Clinical Operations team
Executive Assistant, C-Level Team
Napo Pharmaceuticals, Inc.
10.2005 - 06.2010
- Primary assistant to entire executive team which included CEO, CFO, CSO, and CMO
- Supported clinical team with processing invoices, planning meetings, and ordering and sourcing study materials
- Event planning including shareholder, investor, steering committee, investigator and board meetings
- Responsible for travel arrangements, heavy scheduling and expenses to include reconciliation of executive corporate and personal credit cards
- Liaison between shareholders and transfer agent
- Project management of print and web-based materials (such as the Prospectus and Website)
- Coordinated complex schedules for executives, ensuring optimal time management and prioritization of tasks.
Education
Bachelor of Arts - Liberal Studies
San Francisco State University
Overview of Drug Development and Good Clinical Practices Part I and Part 2
SFSU Extending Learning
Skills
- Effective problem resolution, versatile in dynamic environments
- Project timeline management, prioritization, scheduling, thoroughness in task execution, deadline adherence
- Document organization and management
- Effective Multiple calendar Management
- Domestic/International Travel and Expense utilizing Concur
- Advanced in Microsoft Office, Visio, Sharepoint, Teams, Salesforce and Adobe Applications
- Strong Documentation and Data analysis skills utilizing Learning Management Systems, Document control management systems, Clinical Trial Data Management Systems
- Website Maintenance
- Accounting support, billing and coding
- Event management, planning and execution
- Multi-operations management
- Budget development and maintenance
- Subcontractor and Vendor oversight
- Recruiting and Onboarding management
Timeline
Project Coordinator, Medical Writing
Ultragenyx (contract)
10.2021 - 07.2022
Executive Assistant, Commercial & Corporate Communications
Atara Bio (contract)
08.2020 - 10.2020
Assistant to Vice President of Quality, Quality
FibroGen
04.2013 - 06.2019
Senior Administrative Assistant, Medical Affairs Medical Affairs
Theravance (contract)
02.2012 - 11.2012
Administrative Assistant II, Clinical Operations
BioMarin (contract)
06.2011 - 02.2012
Executive Assistant, C-Level Team
Napo Pharmaceuticals, Inc.
10.2005 - 06.2010
Overview of Drug Development and Good Clinical Practices Part I and Part 2
SFSU Extending Learning
Bachelor of Arts - Liberal Studies
San Francisco State University