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Resume alert |
Resumes 1 - 10 of 743 |
Montville, NJ
... and site assessment Individual and large group training on EDC methods and best practices Liaison between sponsors, the FDA and research sites Responsibilities included a Phase III dermatology NDA, a pre-market maintenance study for a new ...
- Apr 30
Kendall Park, NJ
... EDUCATION Master’s of Science in Regulatory Affairs & Health Policy MCPHS University Boston, MA Dec 2017 GPA:3.91/4.00 Bachelor’s of Science in Pharmacy Veer Narmad South Gujarat University India May 2005 GPA: 3.25/4.00 EDUCATION DETAILS • FDA ...
- Apr 29
Morristown, NJ
... Strong understanding of IT Governance (SOX ITGC) for FDA and global/global regulatory audits. Excellent interpersonal skills to manage multiple priorities in a dynamic environment. Experience in ITSM tools such as ServiceNow to manage global ...
- Apr 22
Hopatcong, NJ
... Supply Chain FDA inspection subject matter expert. • Created and optimized scheduling methodology for an immunotherapy product line. • Responsible for the development and maintenance of production schedules for both commercial and clinical products. ...
- Apr 21
Plainsboro, NJ
... sales and marketing and opinion leaders to develop and implement products labelling strategy to meet the requirements of the FDA and other regulatory agencies to achieve enhanced FDA’s agreements to company’s approval desires based on products ...
- Apr 21
North Plainfield, NJ
... Dayton, NJ • Managed arriving vessels for spice company overseeing and serving as the company’s liaison • Handled the compliance of Customs regulations, in addition to coordinating with FDA and clearing Customs with Brokers • Generated purchase ...
- Apr 15
Piscataway, NJ
... scales for weight verification, and calculators for accurate counts Strict adherence to SOP's which are in compliance with the FDA, CGMP, ISO regulations and company health and safety procedures This includes line clearances, set up of batch records ...
- Apr 14
Frenchtown, NJ
... Common Technical Documents (eCTD) submissions for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research, Activity & Support Diagrams, validation and testing of clinical trial systems ...
- Apr 09
Irvington, NJ
... Skills Quality Assurance and Regulatory Compliance as per the relevant regulations Product Development ICHQ8R2, US FDA, WHO, EMA, MHRA Regulatory submission like CAPA reports, CTDs, monthly updates in inspection report response CAPA writing ...
- Apr 07
Plainsboro, NJ
... Implemented new processes that maintain a highly FDA regulated site and a network security design to ensure adherence of HIPPA regulations. Redesigned computer network. Effectively executed new network policies and procedures. Responsible for ...
- Apr 04