- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be Responsible ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- …Maintains personal awareness of developments in the fields of medical information, regulatory policy , adverse event reporting, information storage and retrieval, ... Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... you ready to make a difference? The Position Novo Nordisk is seeking a Senior Scientist to join our RNAi Chemical Development group in Boulder, Colorado. You will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Principal Scientist, Sterile and Specialty Products The Sterile and Specialty Products (SSP) group is responsible for ... Our team is looking for a strong candidate for the position of Senior Principal Scientist (R6) within the Biologics product development group. Primary duties: Be… more
- Merck & Co. (Rahway, NJ)
- …join the-Quantitative Pharmacology and Pharmacometrics --Immune/Oncology-(QP2-IO)-team in the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical ... support in one of the world's most research-intensive biopharmaceutical companies. Senior Specialists in QP2-I/O-will work in collaborative teams with more… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... publicationsUnderstand, coordinate, and document adherence to internal, external, and regulatory compliance requirementsCollaborate extensively and troubleshoot issues by providing… more
- Merck & Co. (North Wales, PA)
- …to other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... in life sciences, preferred.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to… more
- Merck & Co. (North Wales, PA)
- …any study specific partners and/or vendors.Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... in life sciences, preferred. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this … more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...benefit programs including medical, dental and vision coverage; life insurance ; disability insurance ; 401(k) savings plan; flexible… 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
- Novo Nordisk Inc. (New York, NY)
- 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)
- …engage senior leadersNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this ... within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within the company, providing input into research… more
- Merck & Co. (Rahway, NJ)
- …Sciences and will be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position is accountable ... bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… more
- Merck & Co. (Rahway, NJ)
- …marketing execution and budget management.Ensure planning and readiness for senior business and strategy reviews and stakeholder engagement.Engagement with ... chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and reimbursement and… more
- Merck & Co. (North Wales, PA)
- …clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Evaluating pre-clinical and translational work ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …interact with internal and external stakeholders at all levels, including senior management and vendor partnersPossesses a strong understanding of relevant ... regulatory guidelines and compliance requirements pertaining to Medical Affairs...Excel, PowerPoint, Visio)NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage user access and… more
