- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory … more
- Merck & Co. (Rahway, NJ)
- …including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business ... regulatory policies that support work that is executed in Global Regulatory Affairs and Clinical Safety .Ensure organizational compliance with global… more
- Merck & Co. (North Wales, PA)
- … compliance colleagues across the Offices of General Counsel- including with US Regulatory Legal and International Legal & Compliance teams - to provide ... Job DescriptionJob ScopeThe Director, Corporate Affairs and Patient Innovation & Engagement Compliance has global compliance responsibility for all areas of… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (North Wales, PA)
- …strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- ... regulatory requirements and ensure patient safety, quality and compliance .-Oversee PV processes: Responsible for overseeing all PV processes, including adverse… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoring. In this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …, reporting to the Senior Director of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and ... Operations team.Ensure inspection readiness and offer prompt support during regulatory , quality, and safety inspections.Address audit findings and identify trends… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The successful candidate must function well ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Merck & Co. (Rahway, NJ)
- …compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations ... a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key… more
- Merck & Co. (Rahway, NJ)
- …development and maintenance of Core and US Labeling for assigned products, ensuring compliance with internal and regulatory standards.You will assist in the ... subject matter expert, providing advice and guidance on labeling to teams.As the regulatory labeling liaison on global Regulatory Affairs subteams, your input… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
- Merck & Co. (Rahway, NJ)
- …non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners ... oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and… more
- Merck & Co. (Rahway, NJ)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule ... development to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program development teams,… 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 ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... and framework for driving Go/No Go decisions on programs and rapid regulatory approvalsFoster collaboration within QP2 to achieve results, remove barriers on… more
- Merck & Co. (Rahway, NJ)
- …the product robustness, rapid response to complex investigations and emerging regulatory expectations, and enterprise leadership of technical priorities in support ... business. Risk Management :-Proactively identify potential technical, operational, and regulatory risks.-Collaborate with technical leaders and partners to develop… more
- Merck & Co. (Rahway, NJ)
- …stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key Attributes:Proven ability… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
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