- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study ... provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies.Partner with ... Project Management, Clinical Operations and other functional groups to ensure budgets are always maintained and accurate.Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the control and reporting of approved budgets.OR Functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study ... protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compound(s) and therapeutic areas (TA), under the guidance of the Associate Director, GOMA Scientific Engagement.Contribute to the management and execution of ... community to enable flow of information from/to medical community. Assists Associate Director, GOMA SE in developing Scientific Engagement strategies for the… more
- Abbott (Englewood, NJ)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Clinical Associate ** **About Abbott** Abbott is a global healthcare leader, ... work; monitors performance and reports status to manager. + Acts as a clinical interface between the medical community and the business. + Demonstrates ability to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Senior Clinical Research Associate (CRA) will act as a liaison between BD (the study Sponsor) and the sites/clinics that conduct ... sealants, as well as hernia repair mesh and fixation systems. The Senior Clinical Research Associate (CRA) will act as a liaison between BD (the study Sponsor)… more
- IQVIA (Parsippany, NJ)
- **Position Summary** The Clinical Research Associate (CRA) will be responsible for designing, planning, coordinating, and conducting all activities involved in ... and Knowledge Requirements** + ≥2 years of experience as a Clinical Research Associate , with specific in vitro diagnostics study experience + CRA certification… more
- Fairleigh Dickinson University (Teaneck, NJ)
- …University School of Pharmacy and Health Sciences seeks applicants for a Clinical Assistant/ Associate Professor of Pharmacy Practice within the Department of ... concurrent Master's degree program to qualified pharmacy students. The clinical faculty position is a full-time, 12-month, non-tenure track...at large. This position will be affiliated with a clinical practice site that is seeking a clinical… more
- Fairleigh Dickinson University (Teaneck, NJ)
- Job Summary: Clinical Assistant/ Associate Professor, Physician Assistant Program, participates in teaching didactic and/or clinical courses in the PA ... the Program Director of the Physician Program and carries clinical faculty status within the School of Pharmacy and...scheduling individually and as a team for didactic and clinical courses; coordinates the distribution of lecture hours for… more
- Kean University (Union, NJ)
- …Department of Physician Assistant Studies** **Physician Assistant Studies (12 Month Clinical Assistant/ Associate Professor) -** the MS in Physician Assistant ... 2025. The position below is a twelve-month, full-time, tenure-track Clinical Faculty assignment at the rank of Assistant or... Faculty assignment at the rank of Assistant or Associate Professor. Teaching assignments may be assigned at any… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director, Clinical Pharmacology - Virology** **_*This is a ... **POSITION OVERVIEW:** With considerable independence, you will typically lead clinical pharmacology studies of increasing complexity in Virology focusing on… more
- IQVIA (Parsippany, NJ)
- …with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. * ... letters and other required study documentation. * Act as a mentor for clinical staff including conducting co-monitoring and training visits. * Collaborate and liaise… more
- IQVIA (Parsippany, NJ)
- **Job Overview** Join our team as a Clinical Research Site Manager, where you'll play a crucial role in ensuring our study sites operate seamlessly and adhere to all ... selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. +… more
