Katalyst Healthcares & Life Sciences

Monday, February 11, 2019

Friday, February 8, 2019

Senior SAS Programmer - Buffalo, NY

Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/Client Work with all types of safety data and coding dictionaries (MedDRA and WHODRL) commonly used by the pharmaceutical industry

https://www.indeed.com/viewjob?t=senior+sas+programmer&jk=7ab2a191337e7ff9&_ga=2.109611590.2109980052.1549661589-2077807285.1533320279

Regulatory Affairs Associate, CMC - Richmond, CA

Responsible for the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. Involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. Expertise with biologics and/or drug/biologic/device products is strongly preferred.

https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=bc3b7f840cbc32a8&_ga=2.70862547.2109980052.1549661589-2077807285.1533320279

Validation Engineer - Bridgewater, NJ

Overview: Draft validation documents (VP, URS, Protocols, data migration, RTMs, VSRs, etc.) and route those for review, feedback and approval. Assist user base with execution of protocols and incident management. Review of executed protocols. Need to be Gxp focused and familiar with QA systems (LMS, LIMS, Document management).

https://www.indeed.com/viewjob?t=validation+engineer&jk=379e8e5888b782c8&_ga=2.9662326.2109980052.1549661589-2077807285.1533320279