2 jobs found in Paramus, NJ

 CMC Writer Paramus, NJ CMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA/MAA CTD, EU (IMPD and MAA), US-FDA, FDA, IND, BLA, NDA, eCTD, Project Management, Pharmaceutical  If you post this job on a job board, please do not use company name or salary.  Experience level: Mid-senior Education level: Bachelor’s degree Job function: Health Care Provider Industry: Pharmaceuticals Pay rate : $49 per hour  Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No SUMMARY: A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control. JOB DESCRIPTION: Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing...

Business Analyst with Healthcare Domain   Hackensack, NJ Experience: 12 Years Duration    :  Long term Contract   Need LinkedIn & Passport No with the profile   MANDATOR SKILLS: HEALTHCARE DOMAIN, EHR/EMR systems, healthcare interoperability standards,    HIPAA, HITECH, CMS   Job Description: - Working across functional areas. Demonstrating expertise in clinical electronic information systems for data extraction and reporting. Interpreting business data, analyzing results using statistical techniques, and providing ongoing reports. Collaborating with the Clinical Intelligence and IT teams, as well as subject matter experts, to define reporting solutions. Facilitating project groups in developing survey tools, metrics, dashboards, reports, and oncology monitoring plans with an analytical and statistical focus. Critically evaluating information gathered from...