- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...positive interactions with colleagues. Essential Functions Therapeutic Area: Assist Manager/ Director in review of labeling for marketed products and… 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director...procedures and oversees the quality of the data and safety of the patients. Communicates deviations from the protocol,… 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... Value Proposition: Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Scientific Associate Director , DMPK Project Representative** Challenging. Meaningful. ... drug-interaction potential of drug candidates. Working closely with drug safety and clinical pharmacology, Dev DMPK plays...across the globe. PCO is looking for a Scientific Associate Director to join the Dev DMPK… more
- Catalent Pharma Solutions (Somerset, 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
- Bristol Myers Squibb (Princeton, NJ)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing ... support of BMS medicines and all phases of associated clinical trials. The RAD oversees their regional team to...timelines + Contributes to managing external communication when significant safety issues arise, with the well-being of patients being… 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 (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , Worldwide Oncology Communications, Corporate Affairs The ... Associate Director will be an integral member of the Worldwide...engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the… more
