| Resume alert | Resumes 21 - 30 of 710 |
Computer System Validation
Edison, NJ
... Evaluates validation activities and documentation to ensure that they meet FDA standards, User Requirements, deliverables such as Validation Plan, Test Plan Protocols, Validation Summery report, Risk Assessments Reports, Experience in generating, ... - Feb 21
... Evaluates validation activities and documentation to ensure that they meet FDA standards, User Requirements, deliverables such as Validation Plan, Test Plan Protocols, Validation Summery report, Risk Assessments Reports, Experience in generating, ... - Feb 21
Human Resources Patient Care
Edison, NJ
... Clinical Quality Program Standards Drug Utilization Review Medication Therapy Management Medicare and Medicaid Processes FDA Drug Safety Guidelines and SOP for operations Soft Skills: Detail-oriented, time management, collaborative, teamwork, ... - Feb 19
... Clinical Quality Program Standards Drug Utilization Review Medication Therapy Management Medicare and Medicaid Processes FDA Drug Safety Guidelines and SOP for operations Soft Skills: Detail-oriented, time management, collaborative, teamwork, ... - Feb 19
Regulatory Affairs Project Management
Bridgewater, NJ
JEAN HALLORAN 908-***-**** (Cell) ad3q98@r.postjobfree.com PROFESSIONAL SUMMARY Experienced and dedicated Regulatory Professional with over sixteen years of Regulatory experience in the pharmaceutical industry with a strong focus on FDA Submissions. ... - Feb 19
JEAN HALLORAN 908-***-**** (Cell) ad3q98@r.postjobfree.com PROFESSIONAL SUMMARY Experienced and dedicated Regulatory Professional with over sixteen years of Regulatory experience in the pharmaceutical industry with a strong focus on FDA Submissions. ... - Feb 19
Software Development Management Process
Edison, NJ
... Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements. Celgene Inc. – Summit, NJ (http://www.celgene.com) IT Consultant February 2005 – April 2006 IT Projects – ... - Feb 17
... Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements. Celgene Inc. – Summit, NJ (http://www.celgene.com) IT Consultant February 2005 – April 2006 IT Projects – ... - Feb 17
Database Administrator Sql Server
Princeton, NJ
... Created multiple Oracle instances for Argus Safety & Risk management application according FDA regulations. Setup and Configure HA solution using Oracle physical standby database. Recover standby database as and when required. Monitor and ... - Feb 14
... Created multiple Oracle instances for Argus Safety & Risk management application according FDA regulations. Setup and Configure HA solution using Oracle physical standby database. Recover standby database as and when required. Monitor and ... - Feb 14
Medical Reviewer Drug Safety
Edison, NJ
... Well versed with regulations related to prescribed products and medical devices and current with the regulatory requirements and expectations including EMA ICH GVP Modules, FDA IND and NDA reporting requirements and global risk management ... - Feb 09
... Well versed with regulations related to prescribed products and medical devices and current with the regulatory requirements and expectations including EMA ICH GVP Modules, FDA IND and NDA reporting requirements and global risk management ... - Feb 09
Quality Assurance Control/Production Management
Parlin, NJ
... * Reviewed and approved Batch documentations for FDA regulated products. * Document control coordinator for the organization, keeping track of procedures and their lifecycle, issue new procedures and archive old when no longer needed. * Setup ... - Feb 06
... * Reviewed and approved Batch documentations for FDA regulated products. * Document control coordinator for the organization, keeping track of procedures and their lifecycle, issue new procedures and archive old when no longer needed. * Setup ... - Feb 06
Supply Chain General Manager
Somerset, NJ
... P&L Management - *Technical:* Project Management, Hazmat Certified, 5S & LEAN, Microsoft Suite - *Regulatory:* DOT, FDA, OSHA, Safety & Security Control **Professional Experience:** **United Parcel Services (UPS) - Transportation Department* ... - Jan 23
... P&L Management - *Technical:* Project Management, Hazmat Certified, 5S & LEAN, Microsoft Suite - *Regulatory:* DOT, FDA, OSHA, Safety & Security Control **Professional Experience:** **United Parcel Services (UPS) - Transportation Department* ... - Jan 23
Consultant in CNS drug development, substance use disorder treatments.
New Brunswick, NJ, 08989
... external studies supporting risk mitigation strategies Led global efforts in automation of data capture and Robust Study Design for In Vivo Studies Provided post-marketing support to FDA queries on older small molecules as well as the HIV portfolio. ... - Jan 22
... external studies supporting risk mitigation strategies Led global efforts in automation of data capture and Robust Study Design for In Vivo Studies Provided post-marketing support to FDA queries on older small molecules as well as the HIV portfolio. ... - Jan 22
Medical Affairs and Medical Information Post-Doctoral Fellow
Princeton, NJ
... (KOL) as aligned with medical strategy ● Experienced in promotional review committees to ensure medically supported data through commenting, improving, approving, or rejecting material based on established company practice and FDA regulation. ... - Jan 22
... (KOL) as aligned with medical strategy ● Experienced in promotional review committees to ensure medically supported data through commenting, improving, approving, or rejecting material based on established company practice and FDA regulation. ... - Jan 22