- Actalent (Raleigh, NC)
- …burn with the support of more senior specialists Skills: Contract, clinical research , contracts, negotiation, Regulatory Top Skills Details: Contract, ... Description: * Develop awareness of regulatory legislation, guidance and practice in the assigned...practice in the assigned countries with the support from senior staff * Assist senior staff to… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …pancreatic or advanced solid tumor? We have a role for you! Job Duties: As a Senior Clinical Research Associate, you will monitor clinical trial programs ... experience. + Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and… more
- J&J Family of Companies (Raleigh, NC)
- …of Johnson & Johnson's Family of Companies, is recruiting for a Medical Director/ Senior Medical Director- Clinical Research -Prostate. They will be a member ... Medical Director/ Sr. Med Director, Clinical Research - Prostate - 2406167483W...content for regulatory documents. + Works with senior clinical staff, establishes credible relationships with… more
- J&J Family of Companies (Raleigh, NC)
- …Be passionate about Regulatory Affairs impact in support of the research , development, clinical , marketing, and production of state-of-the-art class III ... Senior Regulatory Affairs Specialist - 2406193618W...Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance * Ability… more
- IQVIA (Durham, NC)
- …of Project management practices and terminology. Req * Requires good knowledge of applicable clinical research regulatory requirements ie, Good Clinical ... Job Overview Senior Clinical Leads are an integral...clinical trial conduct, and skill in applying applicable clinical research regulatory requirements ie… more
- United Therapeutics (Durham, NC)
- … clinical trial material (CTM) is available for sites and/or Contract Research Organizations (CRO); Lead final clinical study report writing to summarize ... duties as required **For this role you will need** Minimum Requirements + For Senior ( Clinical ) Product Development Scientist level: + Bachelor's degree with at… more
- United Therapeutics (Durham, NC)
- …biopharmaceutical research & development or CRO + Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and ... II level: + 8+ years of experience in biopharmaceutical research & development or CRO + For Senior...and department processes + Experience with training and mentoring clinical research staff + Experience with … more
- ThermoFisher Scientific (Morrisville, NC)
- …for cancer. **How will you make an impact?** The **Sr. Director, Procurement - Clinical Research Group (CRG)** is the global leader responsible for developing ... agencies. + Requires strategic business partnering with Medical Affairs, Regulatory , Clinical Operations, Project Management, Patient Advisory Services and… more
- Edwards Lifesciences (Raleigh, NC)
- …+ Bachelor's Degree + A minimum of 4 years' experience related experience in clinical research , data management, software programming or related field + Ability ... your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …about evolving regulatory requirements with regard to use of observational research in the life sciences sector, ensuring that conduct of RWE practices comply ... Overview:** The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and… more
- Merck (Raleigh, NC)
- …of our end-to-end pipeline support in one of the world's most research -intensive biopharmaceutical companies. Senior Specialists in QP2-I/O will work in ... for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency interactions. You will also… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …statistical software) * Works with internal teams (eg, marketing, managed markets, clinical development) to support outomes research , quality of life, and ... and Outcomes Research (HEOR) in support of existing and new clinical applications in coordination with Global and US: Commercial, Medical Affairs, Clinical… more
- IQVIA (Durham, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... a specific CDM task (eg Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where… more
- IQVIA (Durham, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... relationship with colleagues within and outside the department + Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory … more
- IQVIA (Durham, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... **Job Level:** Senior Biostatistician within DSSS **Location:** Home-based in the...ADS and ad hoc analysis specifications. + Contributes to clinical study reports and other regulatory documents… more
- IQVIA (Raleigh, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... a specific CDM task (eg, Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where… more
- Prime Therapeutics (Raleigh, NC)
- …Program Pharmacist is responsible for contributing to the strategy and development of clinical products. This role will provide research , analysis, and reporting ... sight of that. It fuels our passion and drives every decision we make. **Job Posting Title** Clinical Program Pharmacist- REMOTE **Job Description** The Clinical … more
- IQVIA (Raleigh, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where… more
- IQVIA (Durham, NC)
- …degree is strongly preferred. Experience + 4+ years of recent involvement in clinical research or drug development in an academic or industry environment ... and priority per the Operational Execution Plan (OEP) and clinical study protocol. The Senior Study Leader...leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences… more
- Evolent Health (Raleigh, NC)
- …calls) with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request. + Utilizes medical/ clinical review ... the culture. **What You'll Be Doing:** As a Physician Clinical Reviewer, Hematology and Medical Oncology you will be...the Senior Medical Director. May assist the Senior Medical Director in research activities/questions. **Qualifications… more