- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands the ... territory for clinical research , finding and developing new-sites. Participates in internal meetings...monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring ... relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional group in our company's Research Laboratories. Since its ... years of quantitative leadership in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …communication, detailed protocol transfer, quality agreements, regular updates, secure data transfer, regulatory compliance, and effective collaboration.Handling ... therapeutic areas and all phases of clinical development at our company's Research laboratories. TMB laboratories leverage a diverse array of technologies to develop… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Merck & Co. (Washington, DC)
- …not limited to: Research and provide analysis of federal legislation, regulatory proposals, government data , third party stakeholder activities, and other ... Director will monitor, analyze, and communicate internally about federal legislative and regulatory activities and initiatives.- The Associate Director will also… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate … more
- Merck & Co. (Rahway, NJ)
- … data management concepts.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is… more
- Merck & Co. (Rahway, NJ)
- …changing processes and increased reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process ... and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop… more
- Aequor (Thousand Oaks, CA)
- …review, and data verify technical documents such as protocols, reports, regulatory documents, etc. Clearly and consistently communicate data in progress ... and a positive attitude. Critical thinking, problem solving, and independent research skills. Good organizational skills with strong attention to detail. Excellent… more
- Merck & Co. (North Wales, PA)
- … data management concepts.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division,… more
- Eisai, Inc (Nutley, NJ)
- …to healthcare professionals (HCP) and consumers across our Alzheimer's ecosystem.The Associate Director is responsible for building successful, data and ... to partner with internal stakeholders including Brand team, IT, analytics/market research , sales leaders, sales training, legal, regulatory and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell...development. Work with team members and cross-functional teams include research , clinical, and regulatory teams to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThe Site Contracts ... or contracted activities utilizing both performance and quality measurements.The Associate Director, SCBM Financial Reporting & Strategy position provides leadership… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Principal Scientist, Small Molecule Research & DevelopmentIn your role as Associate Principal Scientist, you will be part of a team ... combination products and modalities through analytical characterization, imaging tools, and data analysis. You would also contribute towards regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Regulatory Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The primary… more
