Darlene Pearson Email & Phone Number

(Formerly: Sr. Services & Architecture Assoc/Sr. GD Systems Assoc/Sr. CDRA Systems Assoc)• Spearheaded efforts to drive continuous improvement by enhancing and extending existing systems/platforms to meet business needs• Orchestrated system support and administration activities across Global Development (GD) systems, including task prioritization/delegation and workflow coordination/adjustment for a team of analysts• Supervised process modeling and optimization across GD systems… Show more (Formerly: Sr. Services & Architecture Assoc/Sr. GD Systems Assoc/Sr. CDRA Systems Assoc)• Spearheaded efforts to drive continuous improvement by enhancing and extending existing systems/platforms to meet business needs• Orchestrated system support and administration activities across Global Development (GD) systems, including task prioritization/delegation and workflow coordination/adjustment for a team of analysts• Supervised process modeling and optimization across GD systems, including updating Admin Work Instructions (WI), user admin guides, security matrices, and job aids related to Admin Standard Operating Procedures (SOPs)• Designed and implemented the GxP Electronic Access Request (GEAR) process and workflow to transition from print to digital; defined and enforced adherence to SOPs for managing the GEAR process• Delivered ServiceNow (ITSM) training for colleagues obtaining ITIL access• Generated and maintained training and reference materials, leveraging strong technical acumen and knowledge of industry conditions• Served as a subject matter expert (SME) for Functional Service Providers (FSP), with responsibility for onboarding FSP models, creating onboarding templates, and increasing efficiency of onboarding services• Cultivated and nurtured professional relationships and corporate IT partnerships to elevate service quality• Liaised between IT and other departments regarding updates, issues, transitions, etc. for GD systems to ensure consistency and streamline support to end-users; bridged communications across functional areas to align objectives, share knowledge, and collaboratively address arising challenges• Managed ServiceNow (ITSM) incidents and requests lifecycles, reporting (creating, sharing, training, scheduling), CMDB entries, and Knowledge Base Articles, requirements for workflow development• Steered efforts to maximize portfolio and operational productivity; standardize support, process support, and project support for GD systems. Show less

Tarrytown, New York, United States

Client: Regeneron Pharmaceuticals Inc., Tarrytown, NY• Offered a permanent role few weeks into a 6-month contracted term in recognition of high performance• Furnished direct/backup support and for GD (formerly Clinical Development & Regulatory Affairs [CDRA]) production systems and projects (e.g., GD Workspace, Publishing Solutions)• Demonstrated advanced knowledge of all supported hardware/software/systems, including features, functionalities, and established troubleshooting… Show more Client: Regeneron Pharmaceuticals Inc., Tarrytown, NY• Offered a permanent role few weeks into a 6-month contracted term in recognition of high performance• Furnished direct/backup support and for GD (formerly Clinical Development & Regulatory Affairs [CDRA]) production systems and projects (e.g., GD Workspace, Publishing Solutions)• Demonstrated advanced knowledge of all supported hardware/software/systems, including features, functionalities, and established troubleshooting procedures• Contributed to the planning and execution of projects including system upgrade/implementation support, system user management, end-user support, technical issue resolution, SharePoint site design, documentation coordination, and individual assignments• Interpreted the results of technical troubleshooting to diagnose root causes of identified problems and devise corrective/preventive actions• Oversaw the provision of operational support, backup support, end-user support, system administration, and access control; facilitated ad-hoc training (e.g., Veeva Vault systems [RIM, eTMF, QMS], PleaseReview, SharePoint, etc.)• Produced, edited, revised, and updated training materials to reflect technological/methodological advancements, industry best practices, and relevant federal/state regulations• Streamlined the rollout of the ARGUS Safety Database for Pharmacovigilance & Risk Management, including end-user support and backup system administration Show less

Montville, Nj

Bayer Healthcare / BERLEX, Inc. [Acquired by Bayer], Montville/Wayne, NJ(Previously: Senior Administrative Assistant/Quality Specialist/SOP Quality Manager)• Delivered first-line software/hardware troubleshooting and end-user support/training/mentorship for desktop applications• Oversaw the assessment, procurement, and arrangement of hardware, software, and network access for staff• Optimized site/workplace logistics, including planning, assigning, and negotiating site… Show more Bayer Healthcare / BERLEX, Inc. [Acquired by Bayer], Montville/Wayne, NJ(Previously: Senior Administrative Assistant/Quality Specialist/SOP Quality Manager)• Delivered first-line software/hardware troubleshooting and end-user support/training/mentorship for desktop applications• Oversaw the assessment, procurement, and arrangement of hardware, software, and network access for staff• Optimized site/workplace logistics, including planning, assigning, and negotiating site logistics, onboarding and offboarding, move coordination, equipment needs, furniture needs, personal needs (e.g. handicapped), etc.• Established and updated the US Pharmacovigilance (US PV) SOP Quality Management process necessary to deliver results in accordance with standards and regulations, including managing document change control and security via various Document Management Systems• Supervised the provision of support for various process improvements• Created, verified eCTD readiness, and distributed aggregate reports to Regulatory Affairs for submission to FDA• Appointed as the liaison to the Global Pharmacovigilance (GPV) Process Improvement, the liaison to the Global Pharmacovigilance Business Excellence, and the site administrator, developer, and trainer for the US Pharmacovigilance SharePoint Site Collection• Confirmed the timely transfer and retrieval of all vital records, including adverse event case files, aggregate Periodic Reports, and department-related documentation to offsite storage, and maintained accurate records, in according with the Records Retention Schedule and Corporate Policy• Redesigned the Global Medical Safety Surveillance (GMS) SOP Quality Management process necessary to deliver results in accordance with standards• Governed the workflow process and documentation control of Local and Global GMS Procedures via Document Management System (PlanetOne) to assure compliance with standards and according to planned GMS Workflow timelines Show less

Parsippany, Nj

Client: Berlex, Inc., Wayne, NJ (formerly Berlex Laboratories) (acquired by Bayer in 2007)Temporary Employee - Administrative AssistantProvided administrative support to the Drug Safety Officers and Drug Safety Specialists of the Medical Affairs and Drug Safety Department

Parsippany, Nj

-- Supervised, trained, and mentored Provider Bill Audit (PBA) Overflow Unit-- Technical Advisor for the U.S. Northeast/Mid-Atlantic Region for system troubleshooting, training on Workman’s Compensation claims, coding, state fee schedule, state guidelines, and processing of claims-- Monitored Suspense Reports, Internal Bill Inventory Summary Report, Batch Activation Aging Report, and metrics for assigned region; provided backup to other regions-- Conducted monthly regional… Show more -- Supervised, trained, and mentored Provider Bill Audit (PBA) Overflow Unit-- Technical Advisor for the U.S. Northeast/Mid-Atlantic Region for system troubleshooting, training on Workman’s Compensation claims, coding, state fee schedule, state guidelines, and processing of claims-- Monitored Suspense Reports, Internal Bill Inventory Summary Report, Batch Activation Aging Report, and metrics for assigned region; provided backup to other regions-- Conducted monthly regional conference calls to discuss issues, monitored reports, troubleshooting, and process/training plans Show less

Parsippany, Nj

-- Coded and processed Workman’s Compensation claims, which included Hospital, Doctor, Pharmacy, and Supplier claims-- Conducted Adjudications on all suspended claims, which included verification and cross-referencing of all information submitted on claims-- Performed quality check and conducted Adjustments on finalized claims and corrected as necessary-- Selected out of the PBA Overflow Unit to be the Department Leader, which included training colleagues in coding… Show more -- Coded and processed Workman’s Compensation claims, which included Hospital, Doctor, Pharmacy, and Supplier claims-- Conducted Adjudications on all suspended claims, which included verification and cross-referencing of all information submitted on claims-- Performed quality check and conducted Adjustments on finalized claims and corrected as necessary-- Selected out of the PBA Overflow Unit to be the Department Leader, which included training colleagues in coding, adjudications, and adjustments as well as answering any questions Show less