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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS
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About Company
Science & Biotech - RTP, NC 27710

The Senior Manager RA will serve as the primary liaison with US regulatory authorities and is responsible for assisting with the development and implementation of regulatory strategy • Regulatory life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports, facility/product registrations) • Timely management and preparation of high quality regulatory documents and submissions • Act as the company's primary point of contact for FDA • Establish effective working relationships...

View Sr. Manager, Regulatory Affairs Job - RTP, NC 27710
Science & Biotech - Morrisville, NC 27560

Key Responsibilities of Role • Oversight of Documentation in eDMS MasterControl. o Including uploading documents o Creating Infocards o Collaboration and Quality Checks o Training employees on use of MasterControl o Creation of courses for document training purposes o Writing SOP’s and Work Instructions o Administration of MasterControl • Processing Product Quality Complaints in IQVIA SmartSolve. o Reviewing complaints o Approving Evaluations and Investigations o Corresponding with Suppliers • Review and Approve Product Change, Rewo...

View QA Specialist Job - Morrisville, NC 27560
Science & Biotech - Durham, NC 27710

Perform site monitoring duties assigned for one or more trials. Participate in Study-specific training program, including review key study documents, participate in training sessions Conduct pre-study site qualification visits Conduct on-site study initiation visits to inspect and inventory clinical supplies, review protocol, AE reporting, Site Files, eCRFs and other study related documents Conduct on-site monitoring visits Participate in site escalation process as needed, including root cause analysis, CAPA, and follow through to resolution. ...

View Remote Clinical Research Associate - IVD Job - Durham, NC 27710