- University of Colorado (Aurora, CO)
- …interpersonal communication, interdisciplinary collaboration, problem resolution, decision-making and project /change management. + Ability to integrate clinical , ... and APP training. + Supports the conduct of high-quality research within the Division. + All faculty are asked...Ambulatory team, and Inter-Division leadership as needed to support clinical care, clinic operations, and quality and regulatory… more
- Mount Sinai Health System (New York, NY)
- …and validation of clinical research statistics. + Provides consultation to the clinical research project team on statistical issues related to the ... + 5 years of biostatistics or related experience in clinical research . Non Bargaining Unit, 857 -...life science projects. + May respond to questions from regulatory authorities on statistical issues. + Prepares statistical analysis… more
- J&J Family of Companies (Spring House, PA)
- …collaborate closely with nonclinical safety, pharmacokinetic (PK) and discovery biology project leads, medical writers, global regulatory dossier leaders, and ... improvement; maintain adherence to Standard Operating Procedures (SOPs) and regulatory requirements in partnership with nonclinical, statistical, clinical ,… more
- IQVIA (Durham, NC)
- …SKILLS AND ABILITIES** + In depth knowledge of applicable global, regional, and local clinical research regulatory requirements; ie Good Clinical ... effective relationship building skills. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …HR, Medical Affairs, Specialty Clinical , + Pre- Clinical /Pharmacology, Regulatory , Pharmacovigilance, Health Economics & Outcomes Research , Generics, and ... have strong healthcare industry knowledge, including knowledge and experience working with Clinical and Pre- Clinical Research , Generics, Medical Affairs,… more
- Sanofi Group (Morristown, NJ)
- …Ophthalmology TA, from clinical development plan inception to approval by regulatory bodies as applicable, ensuring project teams are provided with strong ... TA Biostatistics.** You will be leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on … more
- Sanofi Group (Swiftwater, PA)
- … regulatory specifications and strategic messaging to support the clinical development, marketing applications and lifecycle management of the Vaccine portfolio. ... the Medical Writing function in different strategic meetings (eg Clinical and Regulatory Strategic forum (CRSF), CTD...of business considerations (basic finance, human resources). + Extensive project and/or clinical experience in a global… more
- Merck (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... Act as a key collaborator with statistical programming, statistics, regulatory and other project stakeholders. + Responsible...ideas and information into simple readable form. + Solid project management skills. + Familiarity with clinical … more
- Stony Brook University (Stony Brook, NY)
- …in a clinical or research setting. Experience in academic or clinical research imaging. Familiarity with PET research -related documents and SOPs. ... a certified and licensed PET/CT Technologist to provide per diem coverage in a clinical research setting. The ideal candidate must hold active certification in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, ... into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead… more