- Merck & Co. (Rahway, NJ)
- …, including study design, initiation, execution,- monitoring, analysis, regulatory reporting, publication, and presentation at national and international ... clinical study reports, or publication;Participation in internal and joint internal/external research project teams relevant to the development of new… more
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …device development strategy and design controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance ... of materials for program presentations for management review and regulatory submission.Contribute to the development , implementation, and...above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- … research portfolio and building long-term, high-impact relationships.The Pre-Clinical Development Officer will play a critical role in driving revenue growth, ... research , operational, and executive teams to support program development , client acquisition, and strategic partnerships.Responsibilities include: Strategic Leadership:… more
- Merck & Co. (South San Francisco, CA)
- …Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for planning and ... management of an important inflection point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues… 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. (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. (Boston, MA)
- Job DescriptionBe part of a dynamic team that is dedicated to accelerating research and innovation.- We are seeking a passionate and knowledgeable Senior Specialist ... In this position, you will be playing a pivotal role in advancing research by linking our stakeholders with scientific and medical information resources. A… 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
