- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key staff members including senior management, the global functional leads, Regulatory Intelligence , and Policy and company trade association group ... members.Training raises awareness of the topic of clinical trial information disclosure within the company globally. Designs and implements programs to deliver sustainable learning.Provides oversight for the end to end processes across the trial disclosure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Artificial Intelligence (AI) Product Lead is a strategic role focused on defining and driving the ... productivity, customer experience and operational efficiency. Consults with legal and regulatory affairs to address legal considerations and ensure AI solutions… more
- Merck & Co. (Rahway, NJ)
- …intellectually curious, join us-and start making your impact today.-Overview: The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory ... Safety- Operations Process and Systems-(GRACS-OPS) is responsible for the execution of regulatory strategy to get and keep products on the market through the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...relevant science, competitive landscape and policy including detailed competitive intelligence and is viewed as an expert in its… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Merck & Co. (North Wales, PA)
- …and interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors, ... Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... Science and Advanced Analytics functions globally (eg R&D, Clinical, Medical & Regulatory , Finance, Commercial, etc.), in order to effectively increase maturity of… more
- Merck & Co. (Rahway, NJ)
- …Services, this position works closely with Marketing and our company's Animal Health Intelligence Team to provide guidance from a medical perspective on strategy and ... and drivers, customer needs and areas of interest, market and regulatory trends, competitive dynamics, and emerging companies or technologies.Develop a strategy… 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 ... pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
- Merck & Co. (Rahway, NJ)
- …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory … 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external Benchmarking Study Submissions and seeking out external competitive intelligence to provide line of sight to outside environment.Responsibilities:Metrics, ... for End User Education and Dashboards adoption.External Benchmarking Competitive Intelligence . Leverage public source data (Citeline , CMR ,...GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This person is… 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 ... with ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics and pharmacology principles… more
- Merck & Co. (Rahway, NJ)
- …including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at … 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 ... Specialist will develop and execute data science strategies leveraging artificial intelligence (AI), machine learning (ML) and natural language processing (NLP)… more
- Merck & Co. (Rahway, NJ)
- …at the right time? Are you passionate about Digital Pathology/Artificial Intelligence /Machine Learning and how it can revolutionize patient selection? Are you ... internal stakeholders across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic & device… more
- Merck & Co. (North Wales, PA)
- …to drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc. Our US marketing team has adopted an Agile operating ... shared stakeholders across business priorities Collaborating with market research, competitive intelligence , and analytics teams to generate key insights that inform… more
- Merck & Co. (Rahway, NJ)
- …leader in shelter, non-profit and rescue groups.-Collect and analyze market intelligence to identify customer needs, competitive trends, and opportunities within the ... with internal and external stakeholders, including key opinion leaders, regulatory agencies, and industry associationsDemonstrated ability to draw appropriate and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... under adversity Operational mindset and continuous improvement: Considers compliance, regulatory , quality assurance and other requirements when supporting all… more
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