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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE - cellphoneEMAIL AVAILABLE -email addressSUMMARY Seasoned Grants Coordinator and Project Administrator with experience specific to the Pharmaceutical industry, including Medical Affairs Well versed with MS Office - Word, Excel, PowerPoint, Outlook, and MS Project Supports Project & Program Managers, assisting with project-level planning, analysis, tracking & reporting activities to keep projects on schedule and within budget, using MS Project, MS Access, Clarity and SharePoint An assertive, well-organized and focused individual with diversified program development, training, administrative, accounting and presentation design experience Self-motivated, dependable, dedicated, and able to work independently as well as in a team environment Strong problem solving and analytical skills. Most notably, strong interpersonal skills and a passion for delivering quality results Experience includes working with CRO for Phase III Studies from beginning to end (from assisting with the hiring of Clinical Sites to the reconciliation of TMF contents and document progress, to sending documentation to the FDA for approval) Monitoring of volunteers visits and working with the Medical Writers Knowledge and the know how of Registries, which is the collection of information regarding an individual's disease and/or condition to provide to HCPs and researchersSKILLSMicrosoft Office Suite (Word, Excel, PowerPoint, Access, Outlook), MS Project, MS Visio, Internet Applications, Adobe Photoshop, Accounting Systems, SharePoint, Clarity, RMS, Lotus Notes, WebEx/Webnair Video Conferencing, Interoffice Instant Messaging and Video Chatting and File SharingEXPERIENCENovartis Pharmaceuticals, East Hanover, NJ. 9/2021-12/2022 NOGE Sponsorship Project Coordinator, Medical Affairs (Contract Employee) Responsible for Compliance Reviews; Ensures Sponsorship submissions supported are in alignment with external regulation, industry guidelines and Novartis policy and process. Ensures all NOGE Sponsorships are reviewed by the GRC Advises R2 Reviewer on additional information needed Completes initial compliance review in NGCS Uploads the Novartis LOA according to Signatory approval amount Processes the approval ensuring any applicable GRC decisions and contingencies are documented Tracks Payment Details for all NOGE Sponsorships Updates approved sponsorships and grants trackers Sends monthly sponsorship budget update to Dawn GrossmanFinance Sends monthly approved sponsorships tracker breakdown by TA to Medical DirectorsDirectors of Operations Updates quarterly grant metrics / report card Funding Review Process Executes Funding Review Processes for sponsorships in Medical Affairs. Coordinates information flow from internal and external sources to facilitate the dissemination of information to internal (e.g. Grant Review Committee) and external customers (e.g. external funding requesters) Drive Innovation/Process Improvement Leverages digital capabilities to drive impact and efficiencies within the submission portal. Collaborates to track budget and government reporting Compliance/Reporting Ensures adherence to department Working Practice Documents (WPDs). Ensures accurate and timely reporting of all activitiesBausch Health, Bridgewater, NJ 04/2021 9/2021Medical Affairs Grants Coordinator (Contract Employee) Manage vendor-related activities. This includes (a) creating, modifying and issuing vendor agreements, (b) cycling contracts through the system for signoff, (c) processing the payment of invoices. Vendors include logistics providers, statistical analysis companies, and medical writing groups Ensure that health-care provider related expenses are reported internally to fulfill obligations under our corporate integrity agreement and the Sunshine Act Under supervision of the Head of Medical Affairs, manage investigator-initiated grant request procedures (e.g., documenting communication with investigators regarding study updates, invoice processing and payment tracking) Archive documents as per records retention policy Follow all applicable policies and procedures related to Medical Science Liaisons. This includes, but is not limited to the o Corporate Integrity Agreemento Grants SOPo Grants Committee Mandateo IIS SOPo Grants and Investigator-Initiated Studies Policy o Sunshine ActEisai, Woodcliff Lakes, NJ 06/2017 03/2020Grants Project Coordinator Received and tracked CME (Continuing Medical Education) grant requests and prepared CME grants for review and approval Assisted with contract execution for CME and IIS (Investigator Initiated Research Studies) grants; processed invoices for grants payments Processed grant payments to approved vendors Assisted Senior Coordinator with IIS grant requests activities as requested, including meeting preparation Assisted with processing drug distribution requests received from IIS sites Provided other Coordinator/Administrative duties and special projects for department as needed Provided timely and professional assistance to grant requestors and internal colleagues regarding CME grants Assisted with budget and forecast activities and compliance reporting processes UPS, Mahwah, NJ 01/2017 05/2017Project Administrator (Contract Employee) Microsoft SharePoint development and maintenance including InfoPath forms, workflows, security groups and content Microsoft Access development, maintenance and reporting File Transfer Protocol (FTP) user Administration Scheduling, preparations, follow-up and reporting for Supplier Business Reviews Appropriation dispatching and reporting Record retention coordination including: contract verification, inventory management, reporting and storage Various Department Reporting: Contracts Status Report, Appropriation Spend Report, Purchase Order Spend Report, DIM Report, Customer Service Index Report, Ad-Hoc reports, Procurement Spend Visibility Sandwiches Unlimited, Orange, NJ 07/2016 07/2017 Credit Card Conciliation Coordinator/Analyst Reconciled daily credit card receipts to daily batch reports per Cashier (Excel) Reconciled Vendor reports Balanced books for the shop, deliveries, catering and vendors Sanofi-Aventis Pharma, Bridgewater, NJ 03/2016 06/2016 Project Coordinator, R&D QA Department (Contract Employee) General Administrative Assistant responsibilities (setting up meetings, conference room planning, taking meeting minutes) Training file organization and management (creating PowerPoint presentations, use of Webnair/WebEx/Linx) Historical file organization and management (Lot release files, archiving) Staff meeting management and oversight (communicated with the team regarding ongoing project progress) Meeting minutes (e.g. APQM Update, RQN, etc.) Build file structure, save documents (e.g. email attachments) Project Manager Assistant (hosting meetings in the Managers absence, updating Manager on projects) Assisted with clinical project requirements as needed (gathered information on projects and updated the Manager) Temperature excursions (enabling/trending for Clinical Ops personnel) Pre-approval inspections Product technical complaints (gathered information and communicated to the team) Change control routingMercedes-Benz, Montvale NJ (Contract Employee) 05/2015 08/2015 Created and modified presentations, updated spreadsheets; proficiency with MS Excel, MS Project, Clarity, MS PowerPoint and MS Word Supported Project Manager in training related endeavors, including but not limited to: o Creation of training related documentation and presentation (PowerPoint) o Delivery of process and tool training in a group setting as well as 1:1 sessions (WebEx) o Validated weekly time and project cost tracking and reporting (Clarity) Express Scripts, Franklin Lakes, NJ 09/2013 12/2014 Project Coordinator, QA Department (Contract Employee) Supported Project Manager in training related endeavors, including but not limited to: o Creation of training related documentation and presentation (PowerPoint) o Delivery of process and tool training in a group setting as well as 1:1 sessions (WebEx) Supported internal client point of contact in the facilitation of testing events and escalated concerns when appropriate Understood client's testing objectives through participation in internal meetings with Account Management and project teams Managed expectations for testing Ran test data through a validation tool and re-ran or re-routed depending on rules given by client Validated weekly time and project cost tracking and reporting (Clarity) SharePoint Administrative duties; establish subsidies, grant and remove user permissions, upload documentation, manager versions of documents, site maintenance and clean-up GalaxE.Solutions, Inc., Somerset, NJ 12/2011 07/2012 Project Coordinator, IT DepartmentHorizon BCBS NJ, Newark, NJ 07/2010 10/2011Project Coordinator, IT Department (Contract Employee) Forest Research Institute, Harborside Financial Center, Jersey City, NJ 07/2008 - 07/ 2010 Clinical/Project Assistant, Clinical Development Department (Contract Employee) Montclair State University, Upper Montclair, NJ 07/2001 - 03/2008 Budget & Planning Coordinator/Administrative Assistant, Psychoeducational Center Office Specialist/Administrative Assistant, Senior Vice President for Administration EDUCATIONMetropolitan Institute of Network Technology (Jersey City, NJ) - Network Management (AS Degree) 1996-1998 |
