- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory ... Ophthalmology. The individual functions with a degree of independence and provide regulatory oversight for assigned products in order to optimize product labeling… more
- Merck & Co. (North Wales, PA)
- … Data Management ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...Affairs Compliance , Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , … more
- Repligen (Waltham, MA)
- …customer interactions, as necessary, including acting as spokesperson for Repligen Regulatory Compliance with governmental entities and global regulators. The ... OverviewThe Senior Director , Global Regulatory Affairs will report...ability to effectively communicate Regulatory Compliance , risk and mitigations to Senior… more
- Pall (Miami, FL)
- …related field or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ... innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and guidance to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and industry standards concerning ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV... and Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative… more
- Merck & Co. (Rahway, NJ)
- …to help drive our privacy strategy, implement our global privacy program, ensure compliance with global data protection laws, enable innovation in an evolving and ... other team drives program governance and privacy operations, supporting privacy compliance through the development and maintenance of program strategy, processes,… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
- Eisai, Inc (Raleigh, NC)
- …more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial, ... more complex with the launch of biologic products and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (South San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Merck & Co. (Boston, MA)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical...and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology,… more
- Merck & Co. (Lower Gwynedd, PA)
- …Staff, Modeling Simulations, Molecular Biology, Pharmaceutical Analysis, Pharmacokinetics, Regulatory Compliance , Results-Oriented {+ 5 more}-Preferred ... at Spring House Innovation Park (SHIP) is seeking a Director to join our company and lead a team...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (North Wales, PA)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director , Quantitative Systems Pharmacology (QSP) . QP2-IO team is part of the ... of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative,… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... pharmacodynamic endpoints/platforms, and early phase vaccine trials.Reporting to the Executive Director and Head of TMS (in EDS/BARDS), the incumbent will manage… more
