Memorial Day 2019, May 27, Monday, USA - Katalyst HLS

Memorial Day 2019, May 27, Monday, USA Katalyst HealthCares & Life Sciences On #MemorialDay our respect for those who paid the ultimate sacrifice while serving their country and protecting our freedom. #ServeWithHonor #Freedom #KatalystHLS

https://www.indeedjobs.com/katalysthls/_hl/en_US?cpref=JXWAtnzf3XWjLOi4YeVNLuV7xMD8uRK8KuUGCe4cjWs

Careers at Katalyst Healthcares & Life Sciences Inc

Find your next great career opportunity at Katalyst HealthCares & Life Sciences Inc. Search for job openings today.

https://www.indeedjobs.com/katalysthls/_hl/en_US?cpref=JXWAtnzf3XWjLOi4YeVNLuV7xMD8uRK84nmyHRCe468

Regulatory Publishing Associate - South Plainfield, NJ - Katalyst HLS

Regulatory Publishing Associate - South Plainfield, NJ - KatalystHLS.com Responsible for the compilation, publishing, and technical quality control / troubleshooting of Regulatory submissions. Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSURs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.

https://www.indeed.com/viewjob?t=regulatory+publishing+associate&jk=438e8e8fd88499d3&_ga=2.252386441.1453139292.1557651723-2077807285.1533320279

Pharma Validation Engineer - New York, NY.

Pharma Validation Engineer - New York, NY - KatalystHLS.com Pharma Validation Engineer is responsible for interpreting technology projects in the context of CSV, defining validation approach based on the nature of the project, creating and owning the relevant documentation and activity in alignment with both local and global CSV governance in accordance with cGxP, CFR Parts 11, GAMP V and other applicable regulations or procedures.

https://www.indeed.com/viewjob?t=pharma+validation+engineer&jk=4f95f92b9ab838a4&_ga=2.16284726.1453139292.1557651723-2077807285.1533320279

TMF Specialist, Clinical - Bridgewater, NJ.

TMF Specialist, Clinical - Bridgewater, NJ - KatalystHLS.com TMF Specialist collects, reviews, files, maintains and archives essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 International Conference on Harmonization (ICH) Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, European Medicines Agency (EMA) Clinical Trials Directives), and company Standard Operating Procedures (SOPs) as appropriate.

https://www.indeed.com/viewjob?t=tmf+specialist+clinical&jk=f8c6c314be4d3323&_ga=2.20600760.1453139292.1557651723-2077807285.1533320279

Gilead Sciences to Provide Free Truvada for PrEP® to Support U.S. Initiative to End the HIV Epidemic

Gilead Sciences to Provide Free Truvada for PrEP® to Support U.S. Initiative to End the HIV Epidemic May 9, 2019-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it will donate Truvada for PrEP® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) to the U.S. Centers for Disease Control and Prevention (CDC) in support of national efforts to help prevent HIV and end the epidemic. This medication donation is among the largest ever in the United States and is part of Gilead’s broader ongoing initiatives to help ensure that everyone who can benefit from PrEP is able to access it. Gilead will provide to CDC up to 2.4 million bottles of Truvada® annually for uninsured Americans at risk for HIV. The donation, which extends up to 2030, will transition to Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets), if it is approved for use as PrEP.

https://www.gilead.com/news-and-press/press-room/press-releases/2019/5/gilead-sciences-to-provide-free-truvada-for-prep-to-support-us-initiative-to-end-the-hiv-epidemic

Regulatory Affairs Associate, CMC - Morristown, NJ - Katalyst HLS

Regulatory Affairs Associate, CMC - Morristown, NJ - KatalystHLS.com responsible for ensuring RA CMC technical writing objectives are met by authoring/compiling the chemistry, manufacturing, and control (CMC) sections of clinical and marketing application documents. Also ensure proper communication with all key partners in the functional departments of Research and Development and Commercial groups in support pharmaceutical development and regulatory filings.

https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=920dc828dddf37a6&_ga=2.242643650.1132749158.1556810066-1763958782.1550934870&_gac=1.158927688.1553486033.CjwKCAjw1dzkBRBWEiwAROVDLNf7ITqdLF-71K5gdKrWfjVuvJRIOqvA_46SAs2PUlEadZjDWmRGQRoCXGMQAvD_BwE