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Raleigh, NC
... Prior Authorization Processes, and Switching Infusion Sites as well as Healthcare Providers Reporting and Complying with FDA for Adverse Events and product Complaints, while Educating Patients on Processes of Replacement Doses Working with Biogen ...
- Apr 30
Raleigh, NC
... duties of a clinical and developmental nature in support of multi-center clinical trials to ensure adherence to protocol, FDA, and international guidelines, and to ensure the quality of data received during the start up and maintenance phases of ...
- Apr 11
Garner, NC
... ·Obtained project information, analyzed data, and prepared documents for FDA regulatory submissions. ·Reviewed protocol documentation according to regulatory compliance in preparation for audit review. ·Created work instructions guide and trained ...
- Apr 04
Raleigh, NC
... Drug Safety Alliance, Raleigh, NC 11/2014 – 06/2015 Contract HR Specialist (Contract Completed) Conducted extensive internal record audits to analyze FDA compliance metrics, aligning organizational goals with strategic plan. Assured that vendor ...
- Mar 18
Raleigh, NC
... units Duke Clinical Research Institute (DCRI), Durham, NC March 2017 – July 2017 Contracted Clinical Trials Associate II // Duke Box Committee Member Managed the closing of long-term paper studies, including final QC before FDA and client ...
- Feb 21
Raleigh, NC
... Skills • Proficient in Microsoft Word, PowerPoint, Outlook, and Excel • SAP Super User • Auditing (Internal/External)-BRC, FDA, SQF, FSSC 22000, ISO 9001, AIB, Organic, Halal, Gluten Free, Non-GMO • Lean Six Sigma Methodologies • Total Quality ...
- Feb 04
Raleigh, NC, 27608
... Led the design, implementation, and service of a global SAP data center in a Food and Drug Administration (FDA) regulated environment. The team included project managers, planners, business analysts, technical writers, and system administrators, and ...
- Jan 30
Raleigh, NC
... Attendance of Weekly meetings to guide team for FDA approval. Medtronic, Minneapolis, MN November 2022–July 2023 Senior Clinical Research Associate – Medical Devices (Contract) Served as lead clinical research associate, managing 9+ sites across the ...
- Jan 19
Clayton, NC, 27520
... course Aseptic Certified (Gowning and Clean Room) BioWork Certification Over 15 years of experience working in an FDA regulated environment Mechanically inclined and able to operate and troubleshoot equipment Operates production equipment (i.e. ...
- Jan 07
Raleigh, NC, 27603
... Developed requirements for FDA-compliant hardware infrastructure. Managed and enforced network and software security. Performed regular vulnerability tests, penetration tests, and threat assessments. Supported 4,000 users and developed, validated, ...
- 2023 Nov 27