- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data ... (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level… more
- Lilly (Branchburg, NJ)
- …- $162,800 **Position Description:** The Clinical Trial (CT) Supply Management Associate Director will provide operational leadership of clinical supply ... data , systems, and processes to drive operational excellence and meet Clinical Drug Supply business goals. They will be responsible for driving robust, strategic… 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 global ... Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… 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 ... clinical trials methodology as it relates to clinical development. + Relevant prior data analysis...relates to clinical development. + Relevant prior data analysis planning, execution and delivery experience. + Excellent… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty...execution of strategic global communications programming in support of clinical data and regulatory milestones as well… more
- IQVIA (Bridgewater, NJ)
- …patient lives and advance healthcare innovation across the US and Canada. The Associate Director of Project Management will direct and manage project(s) and/or ... services to address the unique needs of the region. By integrating unparalleled data , advanced analytics, and cutting-edge technology, the US and Canada RBU empowers… more
- IQVIA (Warren, NJ)
- …support of IQVIA (TM) information assets - national, sub-national. patient claims data , channel & specialty offerings across multiple internal and external client ... client relationships across the client organization, including commercial operations, data governance, market research, forecasting, sales operations, IT, and… more
- Lilly (Morristown, NJ)
- …The anticipated wage for this position is $145,500 - $213,400 Scientific and Clinical Experts (SEs/CEs) are individuals who are noted for their expertise in a ... By facilitating scientific exchange between industry and the scientific and clinical communities, MSLs shape the future of healthcare by providing the… more
- AbbVie (Branchburg, NJ)
- …demonstrated, for example, through a peer reviewed publication (preferred) *Effectively analyze pre- clinical and clinical data (required) *Background in ... safety surveillance and authorship of PV documents *Analyze and interpret pre- clinical and clinical safety data and communicate the analysis and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …functions include but are not limited to Clinical Operations, 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,… 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 ... activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. **Responsibilities** **Change Requests for PV Systems** +… 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...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory ... Liaisons to ensure successful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data ....with data manager to ensure high quality data . - Drug Development Strategy: Provides input to multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data ....with data manager to ensure high quality data . + Drug Development Strategy: Provides input to multiple… more
- Sanofi Group (Bridgewater, NJ)
- …and gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical ... Our goal is to lead in patient and scientific knowledge to enhance clinical care. We curate patient and scientific evidence and partner with commercial, regulatory,… more
- Terumo Medical Corporation (Somerset, NJ)
- Director of Sales, North America - PSD Date: Dec 8, 2024 Req ID: 3783 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: PSD Terumo ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. **Functional Expertise:** ... DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure...(CMC) or equivalent preferred **Experience:** + 4+ years of clinical data management medical coding experience in… more
- Haleon (Warren, NJ)
- …innovation and maintenance of business activities, by initially shadowing the Toxicology Associate Director /Sr. Toxicologist. This role will provide support to ... us stand still.** Toxicology is one of five key functions within our Clinical Development (CD) organization where we are the leaders in Consumer-centric Evidence… more