- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- Develop DSI programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety , contract research organizations ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Merck & Co. (Rahway, NJ)
- …effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter expert in CDISC Controlled ... boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety... clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ... on clinical studies and programs. May be responsible to manage one or more clinical scientists. As an Associate Director , a typical day may include the… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Project...day to day management of one or more global clinical studies, in compliance with department safety ... Scientist - 2406187180W **Description** Johnson & Johnson is currently seeking an Associate Director , Clinical Project Scientist to join the Oncology Global… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …national origin, protected veteran status, disability or any other legally protected status. Associate Director Clinical Development Base Salary range $175K ... respect in all we do, create and deliver. The Associate Director / Director Clinical ...as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites… more
- Catalent Pharma Solutions (Hillside, NJ)
- ** Associate Director , Regulatory Affairs** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical ... through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The...consumer and Catalent employee. The primary duty of the ** Associate Director , Regulatory Affairs** is to support… more
- The Mount Sinai Health System (New York, NY)
- … safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for ... The Clinical Research Associate is an integral...The Clinical Research Associate is an integral part of the research...collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB of clinical … more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **SUMMARY** + The Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and ... + Assess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director Regulatory Process Development - 2406185269W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare ... https://www.jnj.com/. **Johnson & Johnson Innovative Medicine, is recruiting for an Associate Director , Regulatory Process Development (RPD).** The position can… more
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... institutional campaigns. + Proven aptitude to analyze and interpret efficacy and safety data. + Experience communicating and negotiating with OPDP/APLB is a plus.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory...effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and 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… more
