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FDA resumes in Watertown, MA

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Resume alert Resumes 1 - 10 of 549

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

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

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

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

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

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

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

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

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

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
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