| Resume alert | Resumes 1 - 10 of 323 |
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
Electrical Engineer Product Development
Taunton, MA
... Documentation of hardware designs, tests, specifications, requirements and simulation results as required by FDA. Altera Cyclone FPGA using Altera IDE tools and timing simulation. Create requirements in DOORS, DFMEA and Fault Tolerant Analysis. ... - Apr 21
... Documentation of hardware designs, tests, specifications, requirements and simulation results as required by FDA. Altera Cyclone FPGA using Altera IDE tools and timing simulation. Create requirements in DOORS, DFMEA and Fault Tolerant Analysis. ... - Apr 21
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
Territory Sales Account Manager
Milford, MA
... - 5/07 • Successfully launched new technology in 6 hospitals and 2 physician’s offices within 6 months • Promoted the first FDA approved human implantable microchip to identify chronic illnesses such as, Diabetes, COPD and Alzheimer's HILL-ROM INC, ... - Apr 04
... - 5/07 • Successfully launched new technology in 6 hospitals and 2 physician’s offices within 6 months • Promoted the first FDA approved human implantable microchip to identify chronic illnesses such as, Diabetes, COPD and Alzheimer's HILL-ROM INC, ... - Apr 04
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
Health Economics Market Access
Brookline, MA
... Industrial Pharmacy, Biostatistics, Pharmacy Practice RESEARCH EXPERIENCE Advancing Breast Cancer Care: Unveiling the Latest FDA Triumph Capstone Project Jan 2024 - Present • Addresses a comprehensive evaluation of AstraZeneca's breast cancer tablet ... - Feb 19
... Industrial Pharmacy, Biostatistics, Pharmacy Practice RESEARCH EXPERIENCE Advancing Breast Cancer Care: Unveiling the Latest FDA Triumph Capstone Project Jan 2024 - Present • Addresses a comprehensive evaluation of AstraZeneca's breast cancer tablet ... - Feb 19
Computer Science Etl Developer
Waltham, MA
... Active Ingredients in Medications • Personal Project • GitHub • October 2023 • Developed an ETL pipeline on AWS EC2 instance, extracting products data of top 10 active ingredients from FDA API. • Utilized Python Pandas for data transformation and ... - Feb 15
... Active Ingredients in Medications • Personal Project • GitHub • October 2023 • Developed an ETL pipeline on AWS EC2 instance, extracting products data of top 10 active ingredients from FDA API. • Utilized Python Pandas for data transformation and ... - Feb 15
Qa Analyst Quality Assurance
Belmont, MA
... oWell versed with FDA 21CFR 820, ISO 13485:2016, ISO 14971:2019, 2017/745, GAMP5, and IEC 62304 oStrong testing skills in Salesforce Mobile App, Salesforce standard object, custom objects, custom fields, page layouts, custom Tabs, Reports and ... - Jan 31
... oWell versed with FDA 21CFR 820, ISO 13485:2016, ISO 14971:2019, 2017/745, GAMP5, and IEC 62304 oStrong testing skills in Salesforce Mobile App, Salesforce standard object, custom objects, custom fields, page layouts, custom Tabs, Reports and ... - Jan 31