Lori Kirsch Email and Phone Number

Serve as administrator of 2 online medical libraries. Lead as a skillful medical researcher with the ability to summarize data from clinical studies, consult on research strategies, and edit statistical/clinical reports.Responsible for content development/editing of complex scientific data with a wide variety of audiences.Experience in implementing strategies and tactics spanning across durable and electronic media (e.g., educational slide presentations, webcasts, and print materials). Serve as Content Manager for web-based medical literature library responsible for weekly publication updates, e-newsletters, and metrics reports.Utilize interdepartmental communication skills in liaising between external agencies, CROs, and clients.Implement editorial tasks as a member of AS&K Mercury Healthcare Communications account teams. Duties include: editing, proofreading and organizing artwork and typesetting of editorial projects under the supervision of an Editorial Manager, in liaison with other members of the account team.Effectively ensure the accuracy, consistency and referencing of projects as part of the project team.Liaise between cross-functional department team members, managing selected writing projects to ensure that background materials are provided, timelines are communicated, and questions are answered.Specific duties include: handling day-to-day project management, assisting with research, organizing study data, performing accuracy checks, summarizing important details, referencing, and proofreading.Organize files, including: regulatory binders, study specific source documentation, and other materials.Work to develop new material, including research, proposal writing, and development of concepts.Consistently exceed team performance for compliance with customer service standards and policies.

Participated in study design meetings along, which included teleconferences and in-person client testing.Designed end-user documentation with plan specifications, call flow charts, and other study related documents as necessary. Assured specifications and other study-related documentation as necessary.Aided in design and implementation of IVRS/IWRS systems. Created and executed unit testing plans.Served as a liaison with UK and inter-departmental colleagues on possible project-related issues.Identified and resolved design issues in early stages to keep projects on time and within budget.Created user acceptance testing materials and supported the client testing process by being available to provide client with completed documentation that IVRS/IWRS system accomplished its intended goals.Collated completed study validation packages for transfer to the UK for the Clinical Project Managers.Raised Project Amendment Forms, tested PAF changes, and followed through to completion and go-live.Consistently reviewed and approved test results and confirmed that they met the project requirements.Experienced in working with project managers on project plans, delivery schedules, and project efficiency.Wrote detailed project plans, specification documents, test cases, and technical release documents.

Was hired as a contractor to separate and merge documents in the Takeda documentation system.Assigned for identifying and organizing medical and legal HIPPA documents; researched, indexed, retrieved, and copied all types of physical and electronic records the Records Management System (RMS).Provided a broad range of record-related support (e.g., verified the filing accuracy of physical and electronic records in accord with the business unit’s file plan). Validated agreement between web-based clinical data with original source documentation, and ensured all data met reporting requirements.Assisted in performing routine quality control procedures to verify quality of records management data in the Records Management System. Was responsible for performing quality control procedures for RMS.Built and developed business relationships vital to the success of organizing medical and legal documents. Provided support to management and team members on project management tools and techniques.Identified business challenges and collaboratively shaped solutions to resolve record management issues.Organized data, reviewed methods, and suggested ways to improve Records Management System (RMS).

Hired to effectively track serious adverse events (SAEs) for a major post-litigation case for an anti-inflammatory medication that was taken off the market due to patients experiencing adverse events. Tracked SAEs reported during pre-clinical and post- clinical trials in-line with FDA guidelines.Determined whether the SAE report complied with both company and FDA requirements and procedures.Reviewed and standardized SOP for SAE reporting for pre-clinical and post-marketing clinical studies.Effectively wrote case narratives and performed MedDRA and WHO-DRUG coding for SAE database.Conducted SAE reconciliation, data review, post queries, and close queries; updated the drug database.Investigated incidents; provided written reports on cause; recommended preventative actions to be taken.Provided assessment of SAEs from clinical trials, literature reports, registries, and FDA guidelines.Prepared reports for submission to regulatory authorities and business partners within specified deadlines.