- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …an integral part of the Lovelace Leadership Team, the Vice President of Preclinical Research & Development will develop and lead the all of the Institute's ... Vice President will play a critical role in driving the execution of research and business development initiatives, ensuring operational excellence and fostering… more
- 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)
- … 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. (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. (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)
- …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
- Leica Biosystems (Miami, FL)
- …design and development team to support both IVD medical device and Research Use Only (RUO) product development and sustainment.This position reports to the ... about the Danaher Business System which makes everything possible.The Senior Regulatory Affairs Specialist I is responsible for for pre-market regulatory… 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)
- … regulatory filings.Collaborate with key stakeholders across the organizations ( Research Division / Manufacturing Division) to drive key capability evaluations / ... Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants,… 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
- 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
- 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
- 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. (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
- 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
- Merck & Co. (South San Francisco, CA)
- …for leading the diagnostics strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development . The successful candidate will ... strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role… 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
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