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Resume alert |
Resumes 1 - 10 of 451 |
Natick, MA
... Electronic CTD submissions to the FDA. Electronic Lab Notebook. • International project manager for Cisco VOIP deployment. • Vendor management for enterprise applications, infrastructure, data and voice. SLA contractual agreements and negotiations. ...
- Apr 23
Boston, MA
... Extensive knowledge of pharmacy operations, FDA regulatory affairs, clinical trials of GCP, GMP & GLP, and quality assurance. Proven track record of proper customer advisement and an empathetic attitude towards customers. Superior training and ...
- Apr 22
Brookline, MA
... Regulatory Affairs GPA: 4.0/4.0 Relevant Courses: Regulatory Compliance, FDA Pharmaceutical Regulation, Regulatory Strategy for Product development and lifecycle management, Safety sciences, Human experimentation: methodological issues fundamentals. ...
- Apr 20
Brockton, MA
... Authored company-wide Work Instruction (WI) - Reviewed and processed serious and non-serious product complaints of AEs, including those associated with a medical device, for the FDA, Health Canada and ROW; Initiated and completed the monthly reports ...
- Apr 10
Cambridge, MA
... Draft Business plan with M&A opportunities, FDA/CMS regulations, and ISV market analysis. Revenue N/A CommonWealth Care enterprise Medicare, Medicaid Cloud platform. Gather requirements and manage ISV partners for Enrollment, Reconciliation and ...
- Apr 08
Boston, MA
... Conducted a thorough review and presented research on studies conducted for Sotorasib by referencing multidisciplinary review from Drugs@FDA Drafting IND and NDA documents as per eCTD format in compliance with 21 CFR 312. Mumbai University Jan 2021 ...
- Mar 27
Boston, MA
... Proven track record in improving therapeutic outcomes and streamlining drug therapy processes, demonstrating a solid grasp of GCP, GLP and FDA regulations. EDUCATION: Master of Science in Regulatory Affairs Expected Graduation - December 2024 ...
- Mar 22
Salem, MA
... Babson Development Office (US top Executive diplomacy) Straumann US (dental medical device sales materials generation and research support involving FDA compliance); communications instruction posting in Japan, and Trinity Biotech, Inc., ...
- Mar 12
Waltham, MA
... Provided leadership during shutdowns, product transfer, and start-up processes while adhering to FDA, cGMP, and other regulatory requirements. Experienced in Process Qualification and Execution (IQ, OQ, and PQ), Computer System Validation, Change ...
- Mar 07
Boston, MA
... CERTIFICATION Udemy course on 3d printing from Zero to Hero using FDA/FSLA filament Jul 2018 Professional Training for Building Information Modelling (BIM) by Elephant Creations Apr 2019 Registered Architect with Council of Architecture (COA), India ...
- Mar 03