| Resume alert | Resumes 1 - 10 of 523 |
Drug Safety
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
... 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
Digital Innovation - Strategic Partnerships
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
... 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
Administrative Assistant Executive
Billerica, MA
... Researched FDA websites, printed documents, emailed to requesting individuals. Contact person for department; interfaced with parent company representatives. Contacted German headquarters for inquiries, sent FedEx packages, scheduled meetings. ... - Mar 28
... Researched FDA websites, printed documents, emailed to requesting individuals. Contact person for department; interfaced with parent company representatives. Contacted German headquarters for inquiries, sent FedEx packages, scheduled meetings. ... - Mar 28
Regulatory Compliance Quality Assurance
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
... 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
Clinical Research Regulatory Affairs
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
... 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
Project Manager Marketing Communications
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
... 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
Quality Lead
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
... 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
Project Management
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
... 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
Electro Mechanical Technology Solutions
Lowell, MA
... New Age Technologies, Attleboro MA March 2006 - December 2012 Test Technician ●FDA 21CFR820; DOD-STD-1686; IPC J-STD-001; IPC-A-610 Certified, Class II and III workmanship. ●Perform final test of specific products at clients site testing including ... - Mar 01
... New Age Technologies, Attleboro MA March 2006 - December 2012 Test Technician ●FDA 21CFR820; DOD-STD-1686; IPC J-STD-001; IPC-A-610 Certified, Class II and III workmanship. ●Perform final test of specific products at clients site testing including ... - Mar 01
Regulatory Affairs Supply Chain
Boston, MA
... PROJECTS Constructed a Risk-Benefit Analysis framework for the weight loss medication "Belviq," enhancing understanding of safety data in accordance with FDA and EMA guidelines, analyzing adverse events and beneficial effects. Apr 2023 – Jun 2023 • ... - Feb 29
... PROJECTS Constructed a Risk-Benefit Analysis framework for the weight loss medication "Belviq," enhancing understanding of safety data in accordance with FDA and EMA guidelines, analyzing adverse events and beneficial effects. Apr 2023 – Jun 2023 • ... - Feb 29