Robert Conroy Email & Phone Number

North Wales, Pa

Global Regulatory Affairs and Clinical Safety - RAI HQ OncologyCurrently contract role - Keytruda Oncology Support

North Wales, Pa

Coordinated ORION clean up activities to ensure all approved Registrations exist in ORION and Product Detail Set and Package set information is accurate and up to date. Authored user instructions, presented training, and provided support to the user community.Supported the ORION Data Quality Management Plan (DQMP). Working with IT and consultants developed reports to support the DQMP monitoring activities. Validated and published core reports. Presented training to ORION user groups.Monitor ORION data quality by weekly, monthly, or quarterly report activities, either through query execution or manual review of selected data.MRL team member for the implementation of ORION 2.0.Updated guides for MRL label update process.Created Master and Local Update records for MRL for safety label updates.On team that created and ran excel and SAS reports for MRL global compliance activities.Performed data global data monitoring for safety label activities.Provided training and mentored contract personnel on the MU/LU process.Monitored the MRL mailbox providing support to worldwide users on all MRL related ORION activities.Participated in activities related to the migration from ORION 2.0 to 3.0.UAT; included UAT, business validation, working meetings, user training, report/guide review.Responsible for MRL ORION related business continuity activities

North Wales, Pa

Supports assigned products from the start of the WMA Submission Management ProcessResponsible for: Managing components lists for all versions of WMA/sWMA.Responsible for: WMA/sWMA (including US In-line & ex-US in-line). Responsible for: ex-US Agency responses (e.g. MR/CP/National) and ad hoc ex-US registration support (e.g. EU accession support).Responsible for the coordination of the submission/release of high quality agency communications, reports and other documentation to support assigned products. Review for content and format all documents for submission / release to worldwide regulatory agencies.This includes the following product franchises:--COZAAR/HYZAAR--MAXALT--CANCIDAS (In transition)--25 'In-Line' productsProvide team support:Advising team members of submission requirements, interpretation of regulations and internal guidelines to assure regulatory compliance.Provide support to liaison by scheduling meetings, distributing agendas, and recording meeting minutes.Continue with department tech support: support departmental group 'Regulatory Release Mailbox', web site maintenance, occasionally provide excel training.

North Wales. Pa

Assemble and delivering to the FDA electronic BB-IND submissions.Provide technical support on current WRC tools/processes.Coordinate the assembly and submission/release of high quality agency communications, reports and other documentation to support assigned in-line products (IND/CSA/NDA/WMA maintenance). Collaborate with WRO, CRIS and other groups to formulate and implement IT strategic initiatives for GSRD. Support Organizational Effectiveness and MRL Transformation efforts as appropriate.

North Wales, Pa

Responsible for the coordination of the submission/release of high quality agency communications, reports and other documentation to support assigned products. Review for content and format all IND and NDA/WMA documents for submission / release to worldwide regulatory agencies.This includes the following product franchises:--ZOCOR/MEVACOR --PEPCID OTC 20mg tablet Provide team support:--Providing regulatory support for the review of FDA guidance documents. --Advising team members of submission requirements, interpretation of regulations and internal guidelines to assure regulatory compliance.Provide support to liaison by scheduling meetings, distributing agendas, and recording meeting minutes.Provide regulatory support for IVRS and CSOPS Study Protocol's

North Wales, Pa

Worldwide GMP QAAssure the quality of Merck Biologics Licensing domestic and international vaccine submissions through the auditing of documents and supporting data used in regulatory submissions. Specific projects include the HIV and Human Papillomavirus vaccines. Primary contact for CMC submissions and support documentation. Committee chair for the evaluation of electronic audit techniques. Member of the Freedom of Information and the MRL Commitment Tracking Committee

West Point, Pa

Department of Cancer ResearchMajor research focus was the development of drugs effective for the treatment of cancer. This includes the completion of numerous projects from a basic research/proof of principle phase into the drug development phase.

Nutley, Nj

Hoffmann-LaRoche IncDepartment of Molecular BiologyAssociate Scientist, May 1989-May 1992Major research focus was the study of the enzyme phospholipase A2 and its role in inflammation; involving the isolation, cloning, sequencing, and expression in both bacterial and mammalian cell systems. In addition, a number of DNA mutagenesis techniques were employed to study protein structure-function relationships.Assistant Scientist, October 1984-April 1989Research included DNA sequence analysis of the Human Immodeficiency Virus genome and expression of these proteins in E. coli . Additional projects involved the cloning and sequencing of human lipocortin, the cloning and engineering for bacterial expression of Tumor Necrosis Factor and assisting in the study of protein-structure function relationships of the Chloramphenicol Acetyl Transferase gene.

New Haven, Ct

Yale UniversityResearch Assistant