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

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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.

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Clinical Programmer - Irvine, CA - Katalyst HLS

Clinical Programmer - Irvine, CA - KatalystHLS.com Clinical Reporting Lead will lead the design, development, validation, rollout of reports/dashboards using business intelligence tools (e.g., Spotfire, J-Review) and programs (e.g., SQL, PL-SQL, SAS) used in Clinical Research and Development studies. Additionally, the Clinical Reporting Lead will analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies.

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Clinical Data Manager, Madison, NJ - Katalyst HLS

Clinical Data Manager, Madison, NJ - Katalyst HLS Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock.

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Adjuvant Treatment for HER2+ Early Breast Cancer Receives FDA Approval

Adjuvant Treatment for HER2+ Early Breast Cancer Receives FDA Approval Officials with the FDA have approved ado-trastuzumab emtansine (Kadcyla, Genentech) for post-surgery treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab (Herceptin)-based treatment.

https://www.gene.com/media/press-releases/14785/2019-05-03/fda-approves-genentechs-kadcyla-for-adju

AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

https://news.abbvie.com/news/press-releases/abbvie-expands-immunology-portfolio-in-us-with-fda-approval-skyrizi-risankizumab-rzaa-for-moderate-to-severe-plaque-psoriasis.htm

Increase in Measles Cases — United States, January 1–April 26, 2019

Increase in Measles Cases — United States, January 1–April 26, 2019 From January 1 to April 26, 2019, 704** individual cases of measles have been confirmed in 22 states. This is an increase of 78 cases from the previous week. This is the greatest number of cases reported in the U.S. since 1994 and since measles was declared eliminated in 2000.

https://www.cdc.gov/mmwr/volumes/68/wr/mm6817e1.htm

FDA Approves First Vaccine for Dengue Disease Prevention in Endemic Regions

FDA Approves First Vaccine for Dengue Disease Prevention in Endemic Regions - KatalystHLS.com Officials with the FDA has approved Dengue Tetravalent Vaccine, Live (Dengvaxia, Sanofi Pasteur), the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas.

https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-dengue-disease-endemic-regions