- J&J Family of Companies (New Brunswick, NJ)
- …Function:** Discovery & Pre- Clinical / Clinical Development **Job Sub** **Function:** Clinical Development & Research - MD **Job Category:** People Leader ... input into pipeline development, TPPs, and lifecycle strategy in collaboration with clinical , regulatory , and commercial teams. **3. Cross-Sector Integration and… more
- AbbVie (Florham Park, NJ)
- …or any other related field with 3 years of relevant experience. Clinical research experience strongly recommended; within pharmaceutical industry preferred. ... conjunction with the appropriate cross functional partners. + Ensures project plan integrates and aligns with the product strategic...a cross functional team and managing scientific personnel in clinical research . Must be able to interact… more
- J&J Family of Companies (Raritan, NJ)
- …companies, universities and consultants to align project strategies with the regulatory , preclinical, and clinical strategies for innovative products to meet ... and other life cycle management activities, own Design History Files for LCM project Design and Process Changes, own Design Requirements Matrices for LCM project… more
- Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ)
- …the compilation of the Pharmacovigilance Master File(PSMF) + As needed, work with the clinical project teams, attend clinical team meetings and safety review ... of a Global team implementing and maintaining a PV system that is regulatory compliant and will also support the development, registration and commercialization of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and epidemiological methods to support evidence generation. + Solid understanding of clinical research data standards, eg CDISC, ADaMs/STDMs. + Experienced with ... **Job Summary** Otsuka is looking for a strong Clinical Statistician in the Medical and Real World...role will manage the timely execution of statistical and research methodological components to meet project objectives… more
- Merck (Rahway, NJ)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... **Primary Activities** **:** + Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- J&J Family of Companies (Titusville, NJ)
- …actively involved in creation of Clinical Study Reports (CSRs), publication of clinical research findings and presentations to relevant FDA, EMA, or other ... (including nurse practitioners, physician's assistants and midwifes) with strong clinical / research background would be considered. + Candidates must… more
- Merck (Rahway, NJ)
- …global regulatory expectations of drug and vaccine development, including clinical trial design, clinical pharmacology, biomarker plans, and model-based drug ... Disease, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Phoenix WinNonlin, Regulatory Approvals, Small Molecules, Vaccine Research Current Employees… more
- Virtua Health (Marlton, NJ)
- …to improve care delivery, use resources effectively, and comply with legal, regulatory and clinical policies and procedures. This program is designed ... Job Information: Job Summary: The Physician Hospice is responsible for providing clinical leadership and expertise to the palliative and hospice teams for the… more
- Sumitomo Pharma (Trenton, NJ)
- …of early- to late-stage investigational assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more ... on LinkedIn. **Job Duties and Responsibilities** + Lead on clinical studies and manage/provide training to team members when...Act as a liaison between statistical programming, subcommittees and project teams as + undefined + May serve as… more