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Resumes 31 - 40 of 391 |
Durham, NC
... These are some of the projects I oversaw while at JHMRAD: US Dept of Health and Human Services - DHHS Rockville, MD Document Conversion, Reprographics and Microfilming US Food and Drug Administration - FDA Rockville, MD Document Conversion, ...
- 2023 Aug 22
Wake Forest, NC
... (SOP) System Development Lifecycle (SDLC) Endless abundance of curiosity Workflow optimization Health Information Management FDA Real World Experience (RWE) Regulatory, Risk & Compliance Key Performance Indicators (KPIs) High-energy, agile and ...
- 2023 Aug 21
Cary, NC
... • Experience in Government, Healthcare, HHS, Local and State Governments (US, India and Europe) with delivery experience on GDPR, GXP, HIPPA, FDA, FIMSA and SOX. Information and Solution Architecture, pre-sales and Delivery Management • Develop and ...
- 2023 Aug 07
Durham, NC
... ●Familiar with GxP guidelines, interfaced with business owners and quality assurance organization to ensure that all the documents satisfied GxP and FDA requirements ●Functional consultant with a background in product implementation for various Life ...
- 2023 Jul 30
Durham, NC
... Regulatory maintenance requirements and following SOPs • Submit study start-up regulatory documents to Sponsors such as FDA 1572, Financial Disclosure Forms, CVs, Medical Licenses, Protocol Signature Page, Investigator Brochure Signature Page, etc. ...
- 2023 Jul 11
Durham, NC
... ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements Managing of MBR Leading the Board of Change Managed supplier CAPAs Utilized GxP Ensured the Good Clinical Practices Conducted risk management Utilized Good Lab Practices Utilized ...
- 2023 Jul 07
Cary, NC
... I also have worked in an FDA regulated environment particularly in as aseptic area of class 100, 10K, and 100K. Also, I have had interactions with FDA personnel and inspections. Highly trained and attention to detail have excelled my skills in all ...
- 2023 Jun 16
Durham, NC
... Relevant Regulatory/Clinical Development Experience: ---Special Government Employee (Two Terms): Role: Voting consultant on FDA Gastrointestinal Drug Advisory Committee ---FDA Advisory Committee Presentations ---Label negotiations with FDA ---Active ...
- 2023 May 16
Raleigh, NC
... 1986 Relevant Coursework • Batch Record Issuance/ Approval • Environmental Health & Safety, Industrial Maintenance • Pharmaceutical Quality Control and FDA Regulations, Validation/Protocol Practical Training •Environment Impact analysis• Six Sigma ...
- 2023 Apr 10
Morrisville, NC, 27560
... Possess extensive knowledge about FDA drug safety guidelines, prescription interactions, and pharmacy laws. Exemplary skills in medication dispensation, drug inventory management, and TPN monitoring. Proven ability to advise patients of side effects ...
- 2023 Apr 07