- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our ... pipeline and drive our strategic priorities.The Director, Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of… more
- Merck & Co. (Rahway, NJ)
- …candidate review Education BS or MS with a minimum of 10 years of relevant drug development experience with majority in regulatory orM.D. or PhD/PharmD with a ... minimum of 7 years relevant drug development experience with five years in ...Regulatory AffairsNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement , all… more
- Novo Nordisk Inc. (Boulder, CO)
- …is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... teams.Lead, develops, coordinates, and provides biostatistical support for related drug /vaccine projects in Late Development Statistics.Lead the interaction with… more
- Merck & Co. (North Wales, PA)
- …drug /vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …new formulations and development of robust and scalable processes for parenteral drug products within the small molecule and synthetic modality pipeline.The Director ... scientists.- The main responsibilities include leading the small molecule parenteral drug product team that designs and executes experiments to support formulation… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for a strong candidate ... of Principal Scientist (R5) within the team focused on developing parenteral drug products of small molecule and/or intermediate modalities. The successful candidate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining ... procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release… more
- Merck & Co. (Boston, MA)
- …internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global ... phases (I - IV) of development, including formulation or device changes, drug - drug interaction studies, and studies in special populationsProviding early… more
- Merck & Co. (Rahway, NJ)
- …drug substance manufacture, and authoring of relevant sections of regulatory filingsExperience in excipient, drug product intermediates, formulation ... for physical characterization and crystallization of complex molecules and drug products involving synthetic peptides, oligonucleotides, drug -linkers in… more
- Merck & Co. (South San Francisco, CA)
- …complex in vitro/ex vivo assays and mechanistic experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate ... screening, as well as mechanistic studies to advance a diverse drug discovery pipeline targeting obesity, immune-metabolic, and cardiovascular disorders. In… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed… more
- Merck & Co. (Rahway, NJ)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Build deep fundamental knowledge around the drug ... skillsThe candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/… more
- Merck & Co. (South San Francisco, CA)
- …is seeking a highly experienced and innovative cell pharmacologist with extensive drug discovery expertise in cardiovascular and metabolic diseases to join our ... in vitro/ex vivo assays as well as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... of generating early clinical development plan and Investigational New Drug applications;Developing of clinical development strategies for investigational or marketed… more
- Merck & Co. (Rahway, NJ)
- …strategic thinking skills and an eagerness to learn scientific processes, drug discovery and development processes, regulatory requirements as necessary ... other RaDS architecture and engineering team members.Ensure ongoing compliance with regulatory safety, Good Practice (GxP) and Validation requirements when required.… more
- Merck & Co. (South San Francisco, CA)
- …South San Francisco. The candidate will contribute to Our Company's biologics, drug conjugates, and novel modality discovery and development pipeline. The ideal ... enable FIH translation, and compile non-clinical packages to support regulatory filings. The candidate will collaborate effectively with cross-functional partners… more
- Merck & Co. (South San Francisco, CA)
- …clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and ... Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and… more
- Merck & Co. (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... with ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics and pharmacology… more
