Andrew Swingle Email & Phone Number

Product Master Data Coordination in accordance with Falsified Medicines Directive (FMD) - Document and support coordination and maintenance of FMD master data- Develop cloud based FMD request tracking solution to support FMD process optimizations- Track FMD requests and management of investigative actionsCoordinate and Execute Migration and Validation activities in support of Vault RIM system implementation- Liaise with functional area business representatives to… Show more Product Master Data Coordination in accordance with Falsified Medicines Directive (FMD) - Document and support coordination and maintenance of FMD master data- Develop cloud based FMD request tracking solution to support FMD process optimizations- Track FMD requests and management of investigative actionsCoordinate and Execute Migration and Validation activities in support of Vault RIM system implementation- Liaise with functional area business representatives to identify business rules and decisions for migration value mapping activities- Coordinate UAT execution and evaluate test execution results to determine severity and/or prioritization of test defects- Track and manage post UAT execution defect resolution and coordinate re-testing as neededRegulatory Operations Labeling Management- Author labeling review QC Checklists and work instructions- Perform content and format review of CCDS, US PI, EU SmPC, EU PL and SPL documents- Ensure alignment of regional labels to CCDS and track/report compliance- Provide proofreading review for pre-submission product labeling changesEU & ROW Archiving Project Management- Co-lead regional meetings for global affiliates to present project scope, objectives and desired outcomes- Work with Regulatory Operations to develop and distribute EU/ROW Affiliate Survey using MS Forms- Analyze affiliate responses, lead QA sessions and managed survey data aggregation- Manage project team tasked to evaluate country storage and collect in scope documentationCRF Submission Preparation Team Lead- Develop study specific processes and work instructions- Lead workload and QC coordination efforts for a team of six consultants- Monitor and document schedule and deliverable changes.- Deliver project updates and milestone accomplishments to the client Show less

Bridgewater Nj

Manage the Publishing & Application Life-cycle One team, scheduling and assigning publishing activities while tracking workload and project demands. Prepare and compile eCTD submissions for IND, NDA, BLA, and DMF in support of product development lifecycle and ensuring compliance with FDA 21 Part 11, ICH guidelines and internal practices and procedures. Serve as the technical administrator for US publishing systems, evaluating and resolving technical errors in XML published output. Provide… Show more Manage the Publishing & Application Life-cycle One team, scheduling and assigning publishing activities while tracking workload and project demands. Prepare and compile eCTD submissions for IND, NDA, BLA, and DMF in support of product development lifecycle and ensuring compliance with FDA 21 Part 11, ICH guidelines and internal practices and procedures. Serve as the technical administrator for US publishing systems, evaluating and resolving technical errors in XML published output. Provide support in evaluating issues associated with authored documents. Monitor and maintain product and application information in the Insight Publishing 6.0 environment. Play leadership role in coaching and training team members for changes in regulatory requirements and publishing system environments.ACCOMPLISHMENTS:• Key role in the implementation of Veeva Vault Regulatory Information Management ADMS system. Represented the NA Pharma platform in migration and implementation activities and currently serving as a Super User and Functional Business Administrator.• Held full accountability in the transition of all publishing activities for IND investigator and safety submissions from full-time staff to contracted associates.• Spearheaded initiative to effectuate change in current publishing processes and systems to support the conversion of paper DMFs to eCTD complaint submissions.• Assumed full responsibility, as a system owner, for the design, testing and implementation of the IND-ST System, developed to provide reliable delivery and tracking of safety reports from USPV to Submissions Management.• Represented Regulatory Operations on the DP3/GRA-SMS Insight for Publishing project team to establish user requirements and evaluate three potential publishing solutions. Established workflows, roles/responsibilities and exclusively developed the performance testing strategy used by the project team. Show less

Bridgwater Nj

Manage publishing tasks associated with the compilation and dispatch of investigational and marketed applications. Support publishing of all IND, NDA and BLA application submission types. Coordinate with Regulatory Affairs product teams to meet timelines and deliverables. Coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other Publishers. Administrative tasks Provide support to special projects assigned by the… Show more Manage publishing tasks associated with the compilation and dispatch of investigational and marketed applications. Support publishing of all IND, NDA and BLA application submission types. Coordinate with Regulatory Affairs product teams to meet timelines and deliverables. Coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other Publishers. Administrative tasks Provide support to special projects assigned by the Dossier Publishing Manager. Ensure proper cross-training and support of business process optimization. Monitor and maintain products and applications in the DOMeCTD publishing system. Provide support in evaluating issues associated with authored documents and XML published output.ACCOMPLISHMENTS:• Lead Publisher for Priftin sNDA new indication for the Treatment of Latent Tuberculosis Infection approved by the FDA in 2014.• Lead Publisher for Nasacort Allergy 24HR (nasal spray) OTC Switch approved by the FDA in 2013.• Lead publisher for the Zaltrap Initial BLA and 120-Day safety update. Zaltrap was approved by the FDA in 2012, for use in combination with a FOLFIRI chemotherapy regimen to treat adults with colorectal cancer.• Supported the DOMeCTD upgrade project team to test and implement the S-Cubed publishing system, writing 18 UATs, executing 7 and post approving 4 in addition to performance and regression testing. Acted as one of two members of the migration team to transfer and load 141 product families totaling 570 GBs of data.• Lead publisher in 2010 of an Initial IND for a new basal, long acting, human insulin. Show less

Bridgewater Nj

Manage publishing tasks associated with the compilation and dispatch of investigational and marketed applications. Support publishing of IND, NDA and BLA application submission types. Coordinate with Regulatory Affairs product teams to meet timelines and deliverables. Prepare and compile regulatory submissions in eCTD, eNDA and CTD-Hybrid formats. Ensure submission readiness of documentation by engaging and collaborating with content owners and authors. Coordination of publishing tasks… Show more Manage publishing tasks associated with the compilation and dispatch of investigational and marketed applications. Support publishing of IND, NDA and BLA application submission types. Coordinate with Regulatory Affairs product teams to meet timelines and deliverables. Prepare and compile regulatory submissions in eCTD, eNDA and CTD-Hybrid formats. Ensure submission readiness of documentation by engaging and collaborating with content owners and authors. Coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other publishers.ACCOMPLISHMENTS:• Assisted in witting the Working Practice for the publishing of NDA submissions in eCTD format using eCTDBuilder.• Published eCTD reference submissions for training and publishing examples.• Acted as an SME in the evaluation and testing of the eCTDBuilder publishing solution.• Participated in the DI&A 21st Annual EDM Conference held in Philadelphia, PA Show less

Bridgewater Nj

Bridgewater Nj

Bachelor’S Degree, Computer Information Systems

Business Programing And Web Development

High School