- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing ... centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a... regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), 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...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … 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)
- …and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise: Study ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned ... disorders. **Job Summary:** The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good … more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Clinical Development will have global or ... studies and ensures scientific integrity and interpretation of study data of a clinical development program....based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress. + Manages all aspects of Quality ... quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable...with senior level management, external vendors, collaboration partners and clinical study personnel for clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities + Study Strategy:… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), 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...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing ... centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a... regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields from a ... study protocol + Proficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global… more
- VCA Animal Hospitals (Blairstown, NJ)
- …Doctors and the care team + Opportunities to participate in a robust Clinical Studies program Discover Additional Benefits Benefits | VCA (vcacareers.com) ... Join us as a Medical Director at Blairstown Animal Hospital and you'll quickly...career + Empathetic partners who develop strong client and Associate relationships built on trust **_Total Rewards_** As a… more
- VCA Animal Hospitals (Pen Argyl, PA)
- …US * WOOF University, offering abundant CE for Doctors and Staff. * Robust Clinical Studies program. * Opportunities to give back through strong Shelter ... highly experienced Veterinarian to lead our team as Medical Director . This is an outstanding opportunity to continue practicing...care discounts and more **If you are a current associate , you will need to apply through our internal… more
- Sanofi Group (Bridgewater, NJ)
- …Join our **Biostatistics Immunology & Inflammation as Statistical Project Leader ( Associate Director )** and you'll provide statistical leadership and guidance ... responsibilities:** + Expert level of statistical and scientific contribution to clinical development plans, studies and submissions activities (when… more
