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

ARISg Technical Consultant, NJ - Katalyst HLS

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. "www.KatalystHLS.com"
https://goo.gl/mQVog3

Clinical Document Management Specialist, NY - Katalyst HLS

Responsible to manage documentation associated with clinical trials, both in paper and electronic format, including transitions and conversions. To follow records management tasks, policies and procedures protecting record integrity by ensuring full compliance to GCP principles and client SOPs. "www.KatalystHLS.com"
https://goo.gl/4Oz9Ez

Clinical Research Associate job - Katalyst HealthCares & Life Sciences - Daly City, CA.

March 16, 2017 - Clinical Research Associate - p b Responsibilities: /b /p ul li The Clinical Research Associate reports to the Director for Clinical Operations and is a key member of the Clinical Research and Development team. Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more of the Clinical Development management teams, scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/contracts from CROs, tracking and managing distribution of non-clinical supplies throughout the course of the study.
https://www.indeed.com/viewjob?t=clinical+research+associate&jk=f5dece491d656ae2&_ga=1.174095010.1459745034.1489780381

Risk Management Plan Writer, Pharmacovigilance - Katalyst HealthCares & Life Sciences - Remote.

March 16, 2017 - Risk Management Plan Writer - p b Responsibilities: /b /p ul li Contribute as a part of the Risk Management Plan group within the regulatory writing group. Participate in the development, writing, and management of Risk Management Plans (RMPs) including EU-Risk Management Plans (EU-RMPs) and local RMPs for drug and biologic products
https://www.indeed.com/viewjob?t=risk+management+plan+writer&jk=82a9980fd9dc191e&_ga=1.182549030.1459745034.1489780381

Data Manager - Katalyst HealthCares & Life Sciences, NJ.

March 16, 2017 - Data Manager - p b Responsibilities: /b /p ul li Must be a Senior Level Person and familiar and experienced in all aspects of Data Management Responsibilities. Develop or lead in the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, CRF flow, data queries, manual checks, coding, SAE reconciliation, third party vendor reconciliations, specification of data listings needed to facilitate data cleaning in accordance to a Data Review Plan, data lock and archiving, etc.
https://www.indeed.com/viewjob?t=data+manager&jk=28e10daa404cee6d&_ga=1.111195524.1459745034.1489780381

SAS Programmer - Katalyst HealthCares & Life Sciences, WA.

March 16, 2017 - SAS Programmer - p b Responsibilities: /b /p ul li Experienced SAS Programmer will need to have expert level experience with SAS/MACRO and interfacing with Excel. SAS is running on a UNIX in a GRID environment.
https://www.indeed.com/viewjob?t=sas+programmer&jk=035f9788665fe03c&_ga=1.208351762.1459745034.1489780381

Packaging Validation Engineer job - Katalyst HealthCares & Life Sciences, CA.

March 16, 2017 - Packaging Validation Engineer - p b Responsibilities: /b /p ul li Packaging Validation Engineerswho are good with fill line and / or solid dose packaging qualification /li li
https://www.indeed.com/viewjob?t=packaging+validation+engineer&jk=cbb8a8d708dd7d88&_ga=1.154745400.1459745034.1489780381

Turning Pfizer Discards Into Novartis Gold: The Story Of Ziarco || Katalyst HLS ||

Mike was told in the fall of 2010 that Pfizer was closing the Allergy & Respiratory diseases programs and his own role as the CSO of this group was being eliminated. Rather than seek employment elsewhere, Mike had others ideas.
https://www.forbes.com/sites/johnlamattina/2017/03/15/turning-pfizer-discards-into-novartis-gold-the-story-of-ziarco/#705216187572

Clinical Program Manager job - Katalyst HealthCares & Life Sciences - Edison, NJ.

March 16, 2017 - Clinical Program Manager - p b RESPONSIBILITIES: /b /p ul li The Clinical Program Manager provides the scientific and operational expertise required to conduct clinical
https://www.indeed.com/viewjob?t=clinical+program+manager&jk=5c75665470bfd57b&_ga=1.142103858.1459745034.1489780381

Labelling Service Coordinator, Senior job - Katalyst HealthCare's & Life Sciences - South Plainfield, NJ ||

March 14, 2017 - Labelling Service Coordinator, Senior - Responsibilities: Lead trainer (process & system) to all business partners involved in the labelling approval process, to develop training and communication materials related to the labelling process, to support tracking, publishing and monitoring departmental operational metrics/KPI.
https://www.indeed.com/viewjob?t=labelling+service+coordinator+senior&jk=9b7dbf63c62f0ad3&_ga=1.217258512.723732116.1488996662

REMS Manager job - Katalyst HealthCare's & Life Sciences - Chicago, IL | Indeed.com

March 8, 2017 - REMS Manager - Responsibilities: The Manager, Risk Evaluation and Mitigation Strategy (REMS) is responsible for directing and managing the REMS Department including developing product safety activities as well as any additional Risk Management activities. Katalyst HealthCare's & Life Sciences - www.KatalystHLS.com
https://www.indeed.com/viewjob?t=rems+manager&jk=df6e731e0cafb1b5&_ga=1.137696182.723732116.1488996662

Medical Writer job - Katalyst HealthCare's & Life Sciences - Princeton, NJ.

February 28, 2017 - Medical Writer - Responsibilities: The Medical Writer authors, edits and provides high-quality clinical documents from planning and coordination through delivery of final drafts for regulatory fulfillment of assigned therapeutic areas and/or products in Clinical Development to US and other global health authorities using appropriate processes, tools and technology. Katalyst HealthCare's & Life Sciences; www.KatalystHLS.com
https://www.indeed.com/viewjob?t=medical+writer&jk=769030c1505cb2f0&_ga=1.53177518.723732116.1488996662