- Merck (North Wales, PA)
- …mitigation measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead ... product withdrawal. + Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of… more
- J&J Family of Companies (Horsham, PA)
- …event data collection across trials; and where appropriate, incorporation into obligatory regulatory documents Clinical Project Scientist for TA IIS program ... Manager, Clinical Project Scientist - 2406183870W **Description** Johnson & Johnson Innovative...contributor will be a part of the US Medical Affairs Immunology Clinical Operations & Program Management Team and… more
- Lilly (Indianapolis, IN)
- …operational support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology ... need them all over the world. We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part...and obtaining global product marketing registrations + Development of regulatory strategy to ensure alignment with current… more
- Novo Nordisk (Plainsboro, NJ)
- …personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist /Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents for inclusion in these applications + Review of regulatory strategy documents; eg, provides supervisor with… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Senior Advisor/Director, Global Regulatory Affairs - CMC, Small Molecules** At Eli Lilly, we create ... all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Small Molecules will...molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Clinical Design Scientist - Clinical Design** **Purpose** Clinical Design provides clinical program and trial ... solutions to Lilly's drug development needs. The purpose of the **Clinical Design Scientist ** is to provide Medical and scientific leadership in the clinical program… more
- Abbott (Santa Clara, CA)
- …with other departments including Global Clinical Operations, Research & Development, Regulatory Affairs , and Biostatistics. + Writes, study protocols, protocol ... in more than 160 countries. **Job Title** Sr. Research Scientist **Working at Abbott** At Abbott, you can do...agency meetings. + Works collaboratively with R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group… more
- Abbott (Santa Clara, CA)
- …other departments including Global Clinical Operations, Research & Development (R&D), Regulatory Affairs , Safety and Biostatistics. + Writes study protocols, ... regulatory agency meetings. + Works collaboratively with R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs , Quality Control and Manufacturing Operations by providing ... candidates, supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical… more
- Merck (West Point, PA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late stage Clinical Research… more
- GRAIL (Columbus, OH)
- …, RWE will build and maintain cross-functional relationships with Medical Affairs , Clinical Development, Regulatory , and business teams; and collaborate ... . GRAIL is seeking a talented and experienced Prinicipal Scientist , Real World Evidence (RWE). In this leadership role...registries, etc.), linking & processing this data, and generating regulatory -grade RWE in support of GRAIL's mission to detect… more
- Reynolds American (Winston Salem, NC)
- …External Affairs ) + Provide support for product and process-related regulatory strategies and advocacy efforts, associated regulatory applications, and ... Sr Scientist Heated Product Submissions Reynolds American is evolving...**Global Life Sciences, Product Development, Marketing, Legal and External Affairs , and other SR&D Divisions** **Geographic Scope** Local **Travel… more
- dsm-firmenich (Princeton, NJ)
- …cycle. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group. At dsm-firmenich, being a force for good is not ... Toxicologist/ Scientist Princeton, NJ Hybrid As Toxicologist/ Scientist ,...represent dsm-firmenich in Industry associations. + Support project teams, regulatory affairs , product management, marketing, and product… more
- J&J Family of Companies (Malvern, PA)
- Senior Scientist , Early Development Analytical Scientific Integrator - 2306147399W **Description** Janssen Research & Development, LLC, a division of Johnson & ... Johnson's Family of Companies, is recruiting for a Senior Scientist , Early Development Analytical Scientific Integrator (1 of 2). The position is located in Malvern,… more
- Kelly Services (Raritan, NJ)
- Kelly is hiring for a Contract Data Scientist with our pharmaceutical client in Raritan, NJ. This position is preferred hybrid with 3 days on site a week in Raritan, ... NJ The Contract Data Scientist , Market Access Analytics and Real-World Evidence (MAA &...Analytics and Real-World Evidence group within the Global Commercial Strategy Organization (GCSO) and will work closely with Global… more
- AbbVie (North Chicago, IL)
- …expertise across CMC disciplines to generate collaborations with drug product development and regulatory affairs to further program goals. + The ideal candidate ... a strong understanding of modern organic chemistry and mechanistic theory, control strategy development and regulatory starting material strategies. + An… more
- Bristol Myers Squibb (Princeton, NJ)
- …pharmaceutical industry or other relevant experience + Should be experienced in Medical Affairs , preferred Medical Strategy , for minimum 5 years. + Prior ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Director Medical Scientist works in the US Medical organization as a central part of… more
- Amgen (Washington, DC)
- …execution of R&D strategic imperatives, which span discovery, development, patient safety, regulatory affairs , and our medical affairs . Data scientists ... innovative, driven professionals in this meaningful role. **Senior Data Scientist ** Amgen is on a mission to unlock the...at all stages of drug development. The R&D AI Strategy & Execution (RAISE) team was recently established to… more
- Merck (Kenilworth, NJ)
- …GMP laboratories, Biologics Process Research and Development, Global Quality and Regulatory Affairs -CMC, and our partners in in the commercial/manufacturing ... our Company Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …shape the future of medical science. POSITION SUMMARY We are seeking a Senior Data Scientist to join our Research & Development team. The ideal candidate will have a ... skills to solve complex problems in medical diagnostics. As a Senior Data Scientist , you will lead projects to develop and implement advanced analytics solutions… more