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Data Entry Pharmacovigilance Scientist

Lexington, MA
... • Knowledge about FDA regulations, pre-clinical and clinical requirements, IND submissions and meetings with FDA, cGMP requirements, FDA MedWatch programs. • Gained knowledge on how to review product labelling for compliance with global labelling ... - 2022 Dec 14

Pharmacovigilance/drug safety

West Roxbury, MA, 02132
... Assisted with FDA inspections within drug safety department. Education Widener University, Chester, PA - Pre-med Biology Universidad Iberoamericana, Santo Domingo, RD - Bachelor of Science, Health Science Washington University of Health and Sciences ... - 2022 Nov 30

Time Delivery Software Engineer

Boston, MA
... Comfortable with defining software verification and validation procedures in an FDA regulated environment. Skilled at resolving technical issues and conducting risk analysis activities. Accomplished communicator focused on strengthening ... - 2022 Nov 30

Equipment Operator Assembly Technician

Lowell, MA
... II Applies technical knowledge and excellent hand/eye coordination to assemble semiconductor laser diode components, subassemblies, and other products according to approved drawings and written procedures while complying with FDA, ISO & ... - 2022 Nov 04

Office Assistant Prior Authorization

Billerica, MA
... Circle Award 2019 Served On: Inside Sales Advisory Board 2021 Outstand Prior Authorization Approval 2019 Project: DASH LMR FDA LMR Launch 2018 Quota Attainment Award 2019 Project: Pharmacy First Initiative Program 2020-2021 Winners Circle 2020 ... - 2022 Oct 12

Technical Writer Document Control

Ipswich, MA
... Arena: Pharmaceutical, Biotech, Medical Device, Consumer Goods Organizations: OSHA, ANSI/ISO/ASQC, FDA, Title 21 CFR, ICH, HACCP Concentration: R&D, Quality Assurance, QA Validation, Remediation, SAE, Manufacturing, Logistics, Distribution, Plastics ... - 2022 Oct 12

Data Scientist Research Assistant

Brighton, MA
... Inc, (Atrium Payroll Services), Boston, MA • Deep dived into Pre-Clinical Data generated by Lab and FDA and did Data cleaning, Data Preprocessing, and relevant Data Extraction from database, SharePoint, Web mining using Python and SQL. ... - 2022 Sep 28

Tech skills, design, prototyping, writing, communicating, leadership

North Billerica, MA, 01862
... In 2014 Soteria Medical received marketing approval from the FDA for the first noninvasive diagnostic method for early detection of generalized atherosclerosis. The FDA gave our successful marketing approval submission an A++ rating. We sold Soteria ... - 2022 Sep 27

Postdoctoral Fellow Engineering Manager

Brookline, MA
... Minimally invasive surgery, Pulmonary function testing, Non-invasive monitoring of physiological signals Regulations and Quality: IEC 62304, ISO 13485, IEC 60601, FDA 510(k) System architecture: Complex systems, Multi-domain architecture, Hardware ... - 2022 Sep 24

Account Manager Distribution Specialist

Newtonville, MA
... Sarasota, NY US Business Manager/Consultant 06/2021 – Present Create awareness and “mind share” with end user MD’s and Medical Distributors/Wholesalers for 2 NEW FDA pending diagnostic tests Gather and coordinate “Field Intel” on the market and the ... - 2022 Aug 17
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