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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS

About Company
Lori Steiner has 6 Jobs in Science & Biotech

Science & Biotech - Durham, NC 27707

Responsibilities: • Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage • Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials • Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific...

View Director, Medical Monitoring - Remote Job - Durham, NC 27707
Science & Biotech - Durham, NC 27710

Description: Candidate will be responsible for actively developing new pharma and biotech business to drive new revenue growth in the U.S. Responsibilities include but not limited to acquiring new business and developing relationships through individual’s pre-existing contacts, and may possibly include taking over existing client work. Candidate must be technically independent much of the time, be well experienced in compiling and writing RFP proposals, working in depth with internal core teams and clients for successful technical transfers, have a s...

View Sr. Director Business Development - Remote Job - Durham, NC 27710
CDMO, CMC Manufacturing,
Science & Biotech - Durham, NC 27707

Responsibilities: Conduct research efforts to develop cell and cell/based products and assays for identification of therapeutic targets. Experience Needed: BS-MS Biochemistry, Molecular Biology or Similar Biological Science degree 2-5 years GLP/GMP experience Mammalian Cell culture Aseptic Techniques Flow Cytometry Cell Characterization 2D and 3D cell culture to support tissue regeneration Upstream Process Development Large scale cell culture via Bioreactors Transfer to scale up

View Cell Culture Associate Job - Durham, NC 27707
Science & Biotech - RTP, NC 27707

Responsibilities Maintaining significant knowledge in regulatory requirements and ICH GCP principles. Preparing audit plans for individual audits and audit/risk mitigation plans for larger projects and programs, as needed. Leading and/or assisting with audit activities including sponsor audits, clinical site audits, key document audits and software and system validation documentation audits. Conducting audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG, IP management and distribution, IRB ...

View Sr. QA Auditor - GCP Job - RTP, NC 27707
Science & Biotech - Durham, NC 27703

5+ years' experience as a CRO SAS Programmer CDISC experience (SDTM, ADaM, Define.xml) Experience leading multiple studies across multiple TAs. Experience with Sponsor interaction and bid process activities Experience leading a project team Conduct QC/Validation of SAS code Expertise in SAS language options including Macro language, BASE SAS, SAS/STAT and SAS/GRAPH BS/MS Math, Statistics, Computer Science, or related field

View SAS Programmer - Remote! Job - Durham, NC 27703
Science & Biotech - Durham, NC 27707

The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up,maintenance, and completion activities and develop [Global]Data Management Plans and Quality Management (QM) plans that will deliver accurate, timely, consistent, and quality clinical data. Additional responsibilities include: • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate in the development ...

View Lead Clinical Data Manager - REMOTE! Job - Durham, NC 27707