Christine Stapleton Email & Phone Number

Deerfield, Illinois, United States

Business Administrator for registrations & product lifecycle in Veeva Vault RIM, SBX, VAL, QU environments.; successful migration & testing of multi-tiered data transfer from 2 legacy RA systems.● Updated/verified Baxter’s product licenses/registrations & product-level changes prior to migration/system decommission.● Coordinated annual audit and ensured all updates were captured, provided timely communications, verified all system updates and reported completion.● Completed full training program in Veeva Vault Business and System Administration to support PromoMats and assisted the cross-functional team with coordinating submissions of regulatory / advertising promotional pieces to FDA.● Assisted AdProm team with Veeva Vault System roll-out by providing clear, concise communications, website and process improvement advice, system and security updates, internal customer support and collaborated with IT regarding enhancements.● Participated as an SME on cross-regional communications team to streamline various communications methodologies by brainstorming process improvements for the RA Townhall which included the development and analysis of surveys to determine communication needs.● Managed Internal RA SharePoint and GRA website; successfully migrated content from legacy platform and distributed content between RA SharePoint and web. Maintained green content while performing quarterly quality checks to maintain lifecycle compliance; collaborated with the management team to update GRA website to align changing organizational structures.● Coordinated RA Operations Metrics for Leadership Review by extracting data from SharePoint, gathering metrics from team members, and creating reports with graphics and charts.● Accurately updated and maintained Data Dictionaries for Regulatory, Quality, and Clinical Trials in customized FirstDoc DMS. ● Managed PRIME (MS Project Tracking Tool) with updates to resources, providing reports and RA user technical assistance.

Deerfield, Illinois, United States

Served as CSO signature authority for FirstDoc account requests. User Support / resolver for FirstDoc onboarding and system access. BaxData Account Requests processing. GRA Webmaster providing website maintenance of GRA and FirstDoc Websites.● Maintained documentation / GDP compliance and ensured user system training completion on complex RA systems access forms for users requesting access to FirstDoc.● As BaxData list owner, provided value data review and approval on product records and served as technical data steward providing transition of approved requests into production on legacy registration system.● Regulatory Operations SharePoint site administrator providing share point support and maintenance for the new internal customer support site, RIM SOS SharePoint, and RAO bridge support as requested.● Provided RIM SOS metric reporting, updated sensitive products in FirstDoc system, and secure access to RA eLibrary and RA file shares.

Mcgaw Park, Il

Served as CSO signature authority for FirstDoc account requests by approving account access and ensuring accurate, complete records for system access permissions were submitted with required training documentation and verified completed access requests met GDP standards. Maintained permission levels in FirstDoc for access to restricted products. User Support / resolver for FirstDoc Onboarding and system access.● Successfully led and managed project for RA business to transform hard copy FirstDoc account request form into fully automated SMART form by checking project feasibility with the DDM, engaging the appropriate individuals to map profile options and create a user-friendly “SMART” form utilizing Adobe LiveCycle Designer or Microsoft Word macros, determining availability of technical coding expertise within department; presenting vision to IT to obtain buy-in and collaborating with QMR to determine Quality requirements were met. Project was a successful key component of RSLT support Optimization Initiative, reducing incorrect completion of form by approximately 90%.● Served as GRA Webmaster / TeamSite Branch Owner to significantly improve the overall internal RA website by leading an operations team to collaborate with multiple RA teams to develop consistency and branding across functions while ensuring compliance to corporate website standards. Successfully led projects for BaxEDGE and GRA websites as key components of RSLT support optimization initiative, completing within scope and on time.

Mcgaw Park, Il

● Special projects and process mapping initiatives:● Provided technical and project support to the RAO BRIDGE, a collaboration and web-based solution for the RAPV community.- Collaborated with SMEs to collect content for web pages- Created web pages and web parts utilizing a customized SharePoint- Tested links- Performed quality checks on web page content- Created instructions for Training manual- Reviewed training manuals and performed in-depth quality checks to ensure consistency along with extensive formatting.● Collected process flow information for the BSI organization to help streamline processes and collect data for the development of metrics. Created a quadrant metrics template utilized by operations team members to provide team metrics for Leadership reporting.

Mcgaw Park, Il

Training associate supporting Regulatory Affairs and Pharmacovigilance at Baxter Healthcare. Providing support in extracurricular and internal training, and evaluation of training programs. Facilitated access to external and internal training and education opportunities to meet the professional learning needs of the RAPV organization. Partners with RAPV Management to build knowledge, skills, and expertise within the employee population via education and information relevant to the regulatory affairs and pharmacovigilance disciplines.

Mcgaw Park, Il

Regulatory Affairs/Pharmacovigilance Associate supporting Baxter Healthcare Corporation in Policies, Procedures and Training. - Administered the documentation control system for the development and processing of procedures, forms and manuals for the Global Regulatory Affairs and Pharmacovigilance (GRAPV) organization.- Supported the Training function by identifying, communicating, and coordinating access to external and internal training and development opportunities for the RAPV organization and provided support to the procedures function.

Deerfield, Illinois, United States

Documentation Specialist supporting Baxter/BioLife Plasma Quality/Regulatory

Supported Information Technology global and domestic remote access, relational database/server synchronization and technical support and associated chargebacks.

Mcgaw Park, Il

Supported Vice President of Renal Information Technology and 3 department managers●Operated as IT point of contact for Renal Division, including resource management (access to equipment, software, documentation)●Coordinated videoconference support for Renal Division in McGaw Park, including equipment installation/implementation, demonstrations and training, and troubleshooting

Deerfield, Illinois, United States

Provided administrative support to Vice President of Customer Services and seven department managers

Deerfield, Illinois, United States

Provided administrative and special projects support to Director of Marketing and six staff members.