ARISg Technical Consultant job - Katalyst HealthCares & Life Sciences, NJ.

March 22, 2017 - ARISg Technical Consultant - Responsibilities: Technical person to provide end users support for ARISg tools and MedDRA coding. consultant with 9 to 10 years in implementation and maintenance of safety applications. Strong Experience in ARISg 6.x Safety suite. Good knowledge of Clinical and Safety process, Data Management, Safety Data Processing and applicable regulatory requirements (21 CFR Part 11, ICH-GCP, EMEA, DCGI and etc.,). Profound experience in support activities. Experience in MedDRA coding, WHO drug coding and various reports generation (PSUR, DSUR, CIOMS, MedWatch etc.,)
https://www.indeed.com/viewjob?t=arisg+technical+consultant&jk=ad7b86eb54f80993&_ga=1.213605522.723732116.1488996662

Director Of Medical Communication job - Katalyst HealthCares & Life Sciences - MA.

March 27, 2017 - Director Of Medical Communication - p b Responsibilities: The Director of Medical Communications, Dupilumab, will be accountable for development of the global medical communications strategy, establishment of scientific platforms, and implementation of the medical education and communications plans for Dupilumab in atopic dermatitis. Advanced scientific or clinical degree in the life sciences (e.g., Ph.D., RPh, Pharm.D.) is required. 8-10+ years in scientific communications/medical affairs within pharma/biotech industry is preferred
https://www.indeed.com/viewjob?t=director+medical+communication&jk=a90ed51dde086906&_ga=1.74784276.723732116.1488996662

Director Medical Communication & Publications, Oncology job - Katalyst HealthCares & Life Sciences - MA.

March 27, 2017 - Director Medical Communication & Publications, Oncology - p b Responsibilities: The Director of Global Medical Communications & Publications will oversee the development and execution of scientific communications & publications strategies and plans in Oncology world-wide, with a primary focus in prostate cancer. Doctoral level degree (Ph.D., Pharm.D., or M.D.) in life sciences with minimum of 5 years bio-pharmaceutical industry experience within Medical or Clinical Affairs and Industrial Oncology is required.
https://www.indeed.com/viewjob?t=director+medical+communication+publications+oncology&jk=075feb8ae07f17b2&_ga=1.74784276.723732116.1488996662

Director of Medical Publications, Global Medical Affairs job - Katalyst HLS, MA.

March 28, 2017 - Director of Medical Publications, Global Medical Affairs - Responsibilities: The Director of Medical Publications will be accountable for development and implementation of strategic publication plans for Sarilumab (Kevzara) in rheumatoid arthritis. Advanced Scientific/Medical degree (i.e. PhD, MD, PharmD, MS, MPH), 8-15 years scientific writing, communications, and/or publications experience Minimum of 5 years pharma/biotech industry global or US publications experience Strong analytical and communication skills, both oral and written Doctorate level Scientific/Medical degree (i.e. PhD, MD, PharmD)
https://www.indeed.com/viewjob?t=director+medical+publications+global+medical+affairs&jk=a6af9941fe2a8ebd&_ga=1.53295022.723732116.1488996662

Computer System Validation job - Katalyst HealthCares & Life Sciences - TX

March 27, 2017 - Computer System Validation - Responsibilities: Requires thorough understanding of System Development Life Cycles for FDA regulated applications Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts ( IQ, OQ, PQ ), Traceability Matrix , and Validation Reports . Requires thorough knowledge of US CFR 21 Part 11 regulations.
https://www.indeed.com/viewjob?t=computer+system+validation&jk=6dda6e32bd200565&_ga=1.217413392.723732116.1488996662

Senior SAS Programmer job - Katalyst HealthCares & Life Sciences - NJ

March 30, 2017 - Senior SAS Programmer - Responsibilities: Must have at least 4 years’ current experience within the pharmaceutical industry (Pharma. Biotech, CRO) working as a SAS/Statistical Programmer. Experience in clinical development statistical programming methods and processes in industry setting required.
https://www.indeed.com/viewjob?t=senior+sas+programmer&jk=1f467e928f66fd16&_ga=1.238231430.723732116.1488996662

Labeling Manager, Pharma, NJ - Katalyst HLS

Now Hiring - We have an immediate Full-Time Position available for Labeling Manager, Pharma with our client in NJ. The purpose of the position is to prepare corporate, US and EU labeling (prescribing information, patient information and other required labeling components) documents for developmental, mature and marketed products to obtain company and/or agency approval. Development of labeling for these products is based on study results (including consumer studies), coordination of labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates. Apply: https://goo.gl/FY3JJ4
https://goo.gl/FY3JJ4