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.

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.
• 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.
• 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.

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.
• 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.
• 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.
• 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