Global Labeling Delivery Manager, MD - Katalyst HealthCares & Life Sciences

Global Labeling Delivery Manager - Packaging/Artworks. The Global Labeling Group (GLG) is part of Global Regulatory Affairs and focuses on both the preparation and maintenance of labeling documents for prescribing information, patient information and regulatory information on packages for Health Authority approval.
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Associate Director, Global Regulatory Affairs, CMC I - Katalyst HLS

CMC Regulatory Affairs IgMAX Regulatory CMC strategy Team Lead will provide leadership and be the Regulatory CMC point of contact for major projects in the Plasma OpU, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization of manufacturing. Include formulating and implementing CMC regulatory strategies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements, using contemporary submission standards, and owning all aspects of Modules 2.3/3.
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Technical Writer, Regulatory Affairs, Greater Boston Area, MA - Katalyst HLS

Technical Writer, Regulatory Affairs is responsible for preparation of high quality regulatory submissions and a wide range of supporting do
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Senior SAS Programmer, PA & NJ - Katalyst HealthCares & Life Sciences

Hands-on skills in legacy data conversions to CDISC SDTM data sets. Working experience in generating CDISC ADaM data sets and TLFs to support clinical study reports, ISS or Client. Preparation of electronic submission data package including define.xml for FDA submissions such as NDA or BLA is a plus. Strong working experience with Oncology. BS/MS in statistics or related science with 5+/3+ years of experience in the pharmaceutical industry.
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Quality Control job - Katalyst HealthCares & Life Sciences - Boston, MA |

July 16, 2018 - Quality Control - p b Responsibilities: /b /p ul li The Contractor, Quality Control is responsible for the day-to-day oversight of analytical testing at contract
https://www.indeed.com/viewjob?t=quality+control&jk=784e2730d916f27c&_ga=2.226626910.252329648.1531907807-1408033885.1530798869

Clinical SAS Programmer - Summit, NJ - Katalyst HealthCares & Life Sciences

Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=e902aa37bfec69e1&_ga=2.226779614.252329648.1531907807-1408033885.1530798869

Technical Writer, SOP job - Katalyst HLS - Lexington, MA.

July 5, 2018 - Technical Writer, SOP - p b Job description: /b /p ul li The Standard Operating Procedures (SOP) Technical Writer is responsible for working with Subject Matter
https://www.indeed.com/viewjob?t=technical+writer+sop&jk=c7eda47427419012&_ga=2.79986903.1924989229.1530982037-366033881.1528839132