- Merck & Co. (Rahway, NJ)
- …complementary areas of Analytical Research and Development , Biologics Process Research and Development , CMC and Regulatory in aspects of control ... teams to enable pipeline decisions. -The Executive Director, Biologics Analytical Research and Development (B-AR&D) is responsible for providing strategic and… more
- Merck & Co. (North Wales, PA)
- … Development , Data Management, Epidemiology, Health Economics, Health Outcomes Research , Health Sciences Research , Health Technology Assessment (HTA), ... reviews and meta-analyses, and economic modelling. Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers,… more
- Merck & Co. (North Wales, PA)
- …guidance of an Executive Director, within the Value and Implementation, Outcomes Research the incumbent has the following responsibilities:1.) development of the ... drugs and/or vaccines on a worldwide basis and 3.) development and implementation of Outcomes Research (OR)...plans for in-line and developmental products based on the regulatory , marketing and reimbursement environments on a worldwide basis,… more
- Merck & Co. (Rahway, NJ)
- …reviews and meta-analyses, and economic modelling. Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers, ... The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, commercial and country affiliates.… more
- Merck & Co. (North Wales, PA)
- …DescriptionRole SummaryThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research , position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research , and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position… more
- Merck & Co. (Rahway, NJ)
- … Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories ( Research & Development ) by:Developing an active ... Skills:Required:Global Regulatory experience required across various modality types.M.D. or PhD with >20 years relevant experience preferably with >15 years in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion ... to enhance the value of our oncology pharmaceutical products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary: This position manages ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Rahway, NJ)
- …across the organizations ( our Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC, and technical functions, to ... in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics… more
- Insmed Incorporated (San Diego, CA)
- …evaluating method characteristics like specificity, sensitivity, accuracy, and precision. Manages research and process development samples, manages a group that ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've...analysis are also key duties. Collaboration with R&D, Process Development , Quality Control, and Regulatory Affairs is… more
- Eisai, Inc (Nutley, NJ)
- …company that is breaking through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many ... III studies, and prepare related documentation for submissions.This position will lead a development team with approximately 2-3 MD's or PhD 's, reporting to this… more
- Merck & Co. (Rahway, NJ)
- …Combination Product Working Groups to ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and ... years of combined experience in medical device and combination product development . PhD degree in Mechanical Engineering, Biomedical Engineering, Industrial and… more
- Merck & Co. (North Wales, PA)
- …senior therapeutic area content expert within the company, providing input into research and business development priorities and prioritization of clinical ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Pediatrics will focus on driving strategy, development , and… more
- Insmed Incorporated (San Diego, CA)
- …team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 ... Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you will… more
- Merck & Co. (Rahway, NJ)
- …programs using fed-batch and continuous manufacturing platforms. The Director, Biologics Process Development (BPD) within the Biologics Process Research and ... leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and late-stage pipeline… more
- Merck & Co. (North Wales, PA)
- …position involves interaction with Medical, Data Coordination, Statistical Programming, Research Laboratories scientists and Regulatory staffs in designing ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Eisai, Inc (Exton, PA)
- …company that is breaking through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many ... compliant with regulations and to ensure the successful transfer of new products in development . Requirements Education: BS, MS or PhD in biological sciences or… more
- Merck & Co. (Rahway, NJ)
- … Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs… more
- Formation Bio (New York, NY)
- …and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs ... because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach… more
- Merck & Co. (South San Francisco, CA)
- …Language Processing (NLP), Python (Programming Language), Software Development , Stakeholder Relationship Management, Waterfall ModelPreferred Skills: Research ... leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development ? The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) department… more
