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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS
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About Company
Lori Steiner has 4 Jobs in Science & Biotech

Science & Biotech - Durham, NC 27710

Provide Management oversight of people, policies, and service delivery for clinical research funtions and studies. Provides SME, leads business development efforts for clinical trail engegements and manages projects as required. Serves as CPM for studies and engagements as needed Provide SME on technical issues, business development and project requirmenets Oversee the process of evaluaing client requirments and expectations Manage and oversee CPMs and CRAs including rescourcing, qc of project deliverables, and timely delivery of project delive...

View Director, Clinical Operations - Remote - CRO Job - Durham, NC 27710
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 - 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
Science & Biotech - Virginia Beach, VA 23324

Will support national and international client relationships for clinical studies across all therapeutic areas by developing and facilitating the proposal/grant process for specific clients/sponsors. Responsibilities will include budget and pricing development, proposal writing, contract negotiations, and involvement in coordinating client presentations. Grants pre award experience is highly preferred WORK PERFORMED Proposals and Proposal Revisions • Develop proposals and proposal revisions for investigator-initiated studies, industry-s...

View Contract/Grant and Proposal Development Job - Virginia Beach, VA 23324