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Resume alert |
Resumes 101 - 110 of 526 |
Cambridge, MA
... overall Project Management of multi-center Neurological Disorders Clinical Research Trials • Member of multiple study trial teams, working with PI’s to develop protocols, amendments, consent forms and revisions in line with IRB and FDA regulations. ...
- 2020 Nov 17
Brookline, MA
... CSR, Synoptic CSR, and Supplemental CSR), IB updates, FDA briefing Documents, PRAC Response to Questions (RTQs), Risk Management Plan (RMPs), Risk Evaluation and Mitigation Strategy (REMS), Clinical Overview documents, PSURs, DSURs and PBRER. ...
- 2020 Nov 16
Lowell, MA
... Maintain inventory locations within an FDA compliant warehouse. Pick internal build orders for manufacturing. Pick, pack and ship external customer parts orders utilizing FedEx and DHL. Participate in cycle counting activities. Shipper & Receiver ...
- 2020 Oct 27
Waltham, MA
... Decisions Followed the industry regulations, GXPs, and FDA controls into Supply Chain optimizations using Sage Therapeutics guidelines Worked with vendors RFQ, RFP, SOWs and MSAs for performing the deployment of the Marketing Cloud (SFMC) (VEEVA). ...
- 2020 Oct 21
Boston, MA
... Coursework: The FDA Regulations, Therapeutics Product Development, Human Experimentation, Legal Issues in International Pharmaceutical Regulations (EMA), Global Impact of (eCTD) Submissions, Australia, Canada, Asian and Latin American regulatory ...
- 2020 Oct 13
Concord, MA
... Skills Familiarity with clinical research documentation, ICH-GCP, FDA regulations Ability to multi-task, manage strategic deadlines in a fast-paced environment and work independently with minimal supervision Knowledge of Google Suite, Microsoft Word ...
- 2020 Oct 13
Cambridge, MA
... Researched and developed vital quality assurance documentation, including Food Defense Program and Hazard Communication Program, in compliance with FDA, OSHA, and US Army Bioterrorism regulations for food safety. Communicated with customers and ...
- 2020 Oct 08
Billerica, MA
... of vaccine vials • Evaluated data and prepared reports for component specifications in compliance with cGMP, cGLP and FDA by using Microsoft Excel spreadsheet • Ensured batch uniformity and integrity by communicating and submitting analysis ...
- 2020 Sep 30
Dracut, MA
... with Agile, Forth shift, MAX, EPDM Windchill, PLM, PDM, SAP, STL, DXF, ANSI Y 14.5 and GD&T, Mil Spec, GMP, GDP, ISO 9000, UL, FDA Tooling, Fixture & Enclosure design Working with vendors in machine and sheet metal shops Machining and Sheet metal ...
- 2020 Sep 29
West Roxbury, MA, 02132
... Provide quick statistical programming supports for requiring from FDA and other teams. Create the program to create table, listing and graph for data cleaning, edit check and Ad-hoc requires. Validate and produce TFLs for publications, IND annual ...
- 2020 Sep 03