- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the… more
- Bayer (Washington, DC)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Director , Regulatory Affairs , Molecular Imaging** Join Bayer's ... Candidate. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director , Regulatory Affairs , Molecular Imaging, are to: +… more
- Roche (Indianapolis, IN)
- …Director is done in close collaboration with the global research and development, regulatory affairs and US commercial and access teams to ensure alignment ... Join Roche, where every voice matters. **The Position** **Scientific Strategy Director (Infectious Disease - Molecular Diagnostics)** **The Opportunity:** The… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules ... medicines that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing… more
- Veterans Affairs, Veterans Health Administration (Castle Point, NY)
- …of the EDRP application. Responsibilities VA Careers - Microbiology/ Molecular Medical Technologist: https://youtube.com/embed/eSDGhIwZKdw Total Rewards of a Allied ... of laboratory disciplines: bacteriology, Chemistry (including endocrinology and toxicology), molecular biology, coagulation hematology, Histology, immunology, immunohematology, serology, and… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... is preferred. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance, etc.) is required.… more
- Boehringer Ingelheim (Duluth, GA)
- …new product and marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls (CMC) function for ... with regulatory standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during manufacturing site inspections,… more
- J&J Family of Companies (Spring House, PA)
- …and external human data resources. + Partner with Clinical Development, Global Regulatory Affairs , Data Science, Patient Reported Outcomes, Statistics and other ... step of the way. We are searching for a ** Director , Computational Multiomics, Neuroscience,** to be located at one...& Imaging) to contribute to holistic measurement plans (across molecular , imaging, digital, clinical and other measures) for our… more
- J&J Family of Companies (Spring House, PA)
- …and early and late-stage clinical development, ensuring scientific rigor and regulatory compliance. + Collaborate with internal molecular pathology, biomarker ... discovery, translational research, computer vision, clinical development, medical affairs , diagnostics, regulatory , and commercial teams to assess feasibility,… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs , project management, finance, legal, quality assurance, quality ... Leadership, Medicines and Device Development and Regulation, Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific… more
- Guidehouse (Mclean, VA)
- …FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct ... research and technical evaluation panels. You'll also advise on clinical, regulatory , and manufacturing aspects of medical product development, ensuring alignment… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical Development to ensure ... **Job Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial… more
- Astellas Pharma (Northbrook, IL)
- …in developing strategy for analyzing and assessing biomarker imaging data and molecular biomarker data, including genomics and proteomics, to support decision making ... Lead statistical strategy and representation for biomarker-related topics for regulatory responses and meetings. **Mentorship and Capability Development:** + Mentor… more
- Lilly (Indianapolis, IN)
- …teams, including medicinal chemistry/genetic medicines/bioproducts, toxicology/ADME, bioinformatics, and regulatory affairs , to integrate data and drive ... opinion leaders, and potential partners. + Contribute pharmacology data to regulatory filings, including Investigational New Drug (IND) submissions. + Support… more
- Danaher Corporation (San Francisco, CA)
- …stakeholders, including the US market access team, Data/Analytics, Enablement, Government Affairs , HEOR colleagues, marketing, sales, regulatory and clinical ... life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get… more
- J&J Family of Companies (Spring House, PA)
- …Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Risk Management, Safety Audits, Safety ... strong scientific input regarding potential mechanisms of toxicity in molecular pathways and propose appropriate follow-up. Maintain up-to-date knowledge regarding… more
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