| Resume alert | Resumes 1 - 10 of 538 |
Information Technology Project Management
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
... 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
Quality Assurance Clinical Trials
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
... 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
Clinical Research Regulatory Affairs
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
... 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
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