Marisa Mager (Hoffman) Email & Phone Number

United States

- Responsible for maintenance and support of Veeva Vault R&D systems and related third part applications- Technical design, configuration, and execution support for Veeva RIM, CTMS, eTMF, and Quality Docs applications- User administration, troubleshooting, and routine change support- Provide internal technology expertise to drive technology use forward in a sustainable consistent manner

Austin, Texas, United States

- Oversee data collation/governance activities to ensure information quality in Vault RIM. - Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM. - Manage user groups and workflows and create and maintain archives of Health Authority interactions. - Develop, manage, and distribute reports, dashboards, and templates to meet user needs. - Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management. - Provide Tier 1 support for end users and escalate issues to IT. - Facilitate meetings with decision makers to discuss issues and ensure alignment. - Interact with end users to understand evolving requirements and work with RIM team to map requirements to RIM program roadmap. - Partner with IT and Quality to support system validation activities. - Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM. - Participate in data migration and impact analysis activities, as needed. - Interact with other Vault Business Process Owners across Sage to improve processes and align where necessary. - Serve as primary contact for Health Authority correspondence/submission archives and perform document management/tracking related to archival. - Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, NDA, etc.). - Coordinate and track delivery of required submission content from content/document owners. - Manage timelines for submission deliverables and reviews in accordance with program/corporate objectives. - Publish and submit regulatory submissions as needed.

Austin, Texas, United States

- Member of the largest team of Salesforce and Veeva-certified professionals in the industry.- Lead the development and implementation of Veeva Vault solutions (Quality, Clinical, RIM, Safety, etc.) for top-tier pharmaceutical clients. - Gather and analyze information to define project specifications and requirements, and review design specifications.- Implement a repeatable approach, cohesive framework, and available industry-standard techniques to deliver solutions that are scalable and maintainable.- Identify functional changes for new or existing features to meet business requirements.- Assist client with Veeva release-management strategy and approach. - Write functional specifications, use cases, and requirements that describe the necessary system changes or new system features. - Oversee and motivate a team of both onshore and offshore resources to meet client deliverable dates on time, if not early. - Develop solutions, strategies, and functionality that meet client business, IT, and development teams’ expectations.- Provide functional support to development teams when building custom solutions. - Understand strategic direction and implement methods and procedures that will align with this strategy. - Leverage and adapt existing methods and procedures to create new solutions. - Part of Accenture internal TechStar (highly selective) Program which globally recognizes, inspires, engages and invests in high-performing Technology consultants.

United States

- Oversight and responsibility for the Veeva RIM Vault Implementation for Customers with Releases and Required Technology Upgrades - Managed multiple teams of technology, support, QA, and vendors for Veeva Vault Customer - Oversight of the Project Plan, Roadmap, Schedules, Resources, Status, and Risk Management, collaborating with stakeholders (Infrastructure, IT, strategy, clients, leadership, partners) to determine a plan for release and upgrades- Implemented project management processes into a large-scale new product development program.- Partner with Change Champions to deliver successful “Train the Trainer” for customer - Applied AGILE techniques to Reduce Time to Market for systems from years to months.- Led team of CDP (College Development Program) Analysts through SDLC and Veeva training to become a fully promoted consultant to the Veeva team - Rapidly configure and implement the Vault RIM suite to meet custom client requirements and processes. - Performed project management tasks including resource planning, leading, and motivating a cross-functional team.- Configured and migrated client StartingPoint templates to the new Veeva Vault solution using Veeva best practices.- Created and updated client template materials for RIM processes (SOPs, Work Instructions, Quick Reference Cards, etc.) as part of Veeva’s internal Business Process Development team. - Delivered Business Process Development projects using template materials and altering them to fit client processes, enabling the client to have a successful go-live with procedures in place. - Member of the internal RIM Publishing task force - created many materials for training, delivering, and release management for the Publishing tool used by many clients.

Philadelphia, Pennsylvania

- Member of the Regulatory Domain (RIM).- Implemented Veeva’s cloud software applications for tier 1 pharma clients, including (but not limited to): Submissions, Submissions Archive, Registrations, Publishing, Quality, and eTMF systems. - Provided business process consulting to Regulatory Information Management customers. - Designed and configured custom workflows, lifecycles, objects, and security for Veeva Vault customers based on custom client requirements. - Led business process discovery workshops, gathering requirements, configuring the solution, and performing testing and final deployment.- Created customer validation materials (UAT Scripts, Traceability Matrices, URS, Validation Plan, Validation Summary)- Migrated documents into client environments using FTP and loader functionality.

East Norriton, Pa

- Member of the R&D Center of Excellence.- Participated in teams to structure analyses, assess findings, and develop client recommendations for Veeva Vault solutions. - Participated in business process decomposition and re-engineering in Veeva Vault implementation project teams.- Prepared and delivered custom client Train-the-Trainer materials.- Wrote client project documentation including Working Instructions, SOPs, and Training Materials- Assisted in migrating legacy documents to clients’ new Veeva Vault solution using industry best practices.- Implemented Veeva Vault RIM and IQVIA RIMSmart systems to small to medium pharma/biotech companies and tier 1 pharma companies.

1500 Market Street Philadelphia Pa 19102

- Review Radiation Oncology codes for compliancy prior to billing for the University of Pennsylvania Radiation Oncology Department- Identified and initiated a recovery project of all 77387 (IGRT) codes denied incorrectly from IBC for their commercial plans based on UPHS contract. Recovery project dates back to 2015 and had a net recovery of over $4M.- Appeal denied claims with all Insurance Companies (Pulling medical records from Epic and ARIA)- Research contractual adjustments for underpayments and zero pay- Perform patient billing and reporting activities in a timely fashion - Review patient accounts to identify delinquent and due accounts- Follow collection procedures to receive correct payments- Utilizes computer software to process, print and e-mail patient medical bills- Maintain a database of client accounts and billing information - Contact insurance companies for claim processing and reimbursements- Address billing issues and inquiries from patients- Arrange payment schedules, generate billing entries, print or e-mail bills, and create reports- Perform front-desk duties and administrative work when needed- Coordinate with insurance companies to resolve payment problems and reimbursement issues

Langhorne, Pa

- Front Desk Management (check in/check out)- Obtained insurance information as well as referrals/authorizations- Conducted full and thorough patient registration - Input all patient information data into electronic medical record system (e-clinical works)- Scheduled appointments- Performed patient triage (vitals)- Compiled medical records for legal reports - Reviewed medical records and informed billing department of E&M codes- Scribed office visits- Conducted patient surveys for quality assurance purposes - Shadowed neurosurgical procedures in the operating room- Reviewed patient medical records - Obtained physical therapy, imaging, and pain management reports - Compiled all necessary documentation from physicians, nurse practitioners, and physicians assistants practice wide regarding new/interesting cases that would be presented at monthly NeuroRounds meeting