- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures.Understanding ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device...deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing… more
- IQVIA, Inc. (Durham, NC)
- …Management (Associate) Director will play a critical role in supporting the Regulatory Affairs and Drug Development Solutions (RADDS) team-not through direct ... alignment to help drive success. This is role focuses on the Drug Development & Regulatory Strategy (DDRS) offerings within RADDS. The individual will be focused… more
- Merck & Co. (Rahway, NJ)
- …model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams. Collaborate with other functional areas, as well ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. Educational background in… more
- Merck & Co. (Rahway, NJ)
- …Skills: Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (San Francisco, CA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... Pharmacokinetics, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills: Drug Discovery Process, Global Regulatory , Machine Learning,… more
- Merck & Co. (North Wales, PA)
- …processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Boston, MA)
- … 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory /business… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Rahway, NJ)
- …process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems. Reporting to the Director responsible for this area, ... equipment and processes for clinical and commercial manufacture of drug -device combination products.Hands on troubleshooting in a manufacturing environment with… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... of generating early clinical development plan and Investigational New Drug applicationsDeveloping of clinical development strategies for investigational or marketed… more
- Merck & Co. (North Wales, PA)
- …scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for approval of drug /vaccine products; Prior experiences with ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck & Co. (South San Francisco, CA)
- …you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and ... AI/ML to support efforts in transforming the way PDMB leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… 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 ... Responsibilities :Develops, coordinates, and provides biostatistical support for related drug /vaccine projects under supervision in Late Development Statistics. --Interacts… more
